Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Wounds and Injuries

Breast Neoplasms

Fractures, Stress

Fractures, Bone

Breast Diseases

Skin Diseases

Despite increased access to early detection and the availability of more effective therapeutic strategies, African American women continue to experience excess rates of morbidity and mortality from breast cancer. An emerging hypothesis about breast cancer disparities is that social conditions and physiological responses to social stressors influence biological processes that are important to the initiation and progression of disease. This hypothesis is based on data from animal studies which have shown that rats that are exposed to social stressors such as isolation are likely to develop mammary tumors that are histologically and etiologically similar to those that develop among African American women. The HPA axis plays a central role in regulating the physiological stress response; dysregulation of the HPA has been suggested as a mechanism through which social and biological factors contribute to racial disparities in breast cancer outcomes. Many African Americans experience stressful life events and circumstances, including economic, discriminatory, and other stressors. These social factors may contribute to an increased risk of advanced stage disease, but not all African American women who are exposed to adverse social factors develop advanced stage disease and those who have a limited number of psychosocial stressors can develop advanced stage breast cancer, regardless of early detection. This may be because stress reactivity, or one's physiological and psychological responses to a stressor, is highly individualized and dependent on psychological and social determinants as well as genetic factors. But, these biological and psychosocial pathways have not been examined among women at increased risk for disparities. Therefore, this study will characterize stress reactivity and emotional regulation among African American breast cancer survivors and measure the association between these responses and decisions about cancer control and treatment compliance. As part of providing empirical data on biological and psychological pathways that contribute to breast cancer disparities, the investigator's study will identify novel intervention targets that can be used to improve self-management in a population that is at risk for limited cancer control.

Dysregulation of the HPA has been suggested as a mechanism through which social and biological factors contribute to racial disparities in breast cancer outcomes.The HPA axis plays a central role in regulating the physiological stress response;a prolonged and elevated glucocorticoid (GC) response following a social stressor predicts tumor growth rates and the development of mammary cancer in rats that histologically and etiologically resembles human disease.Many African Americans experience stressful life events and circumstances, including economic, discriminatory, and other stressors. These psychosocial factors may contribute to an increased risk of advanced stage breast cancer among African American women, but not all African American women who are exposed to adverse psychosocial and social stressors develop advanced stage breast cancer and African American women who have a limited number of stressors also develop advanced stage breast cancer, regardless of early detection. This may be because stress reactivity, or one's physiological and psychological responses to a stressor, is highly individualized and dependent on psychological and social determinants. However, empirical data are not available on stress reactivity among African American breast cancer survivors and how these reactions vary among women based on their exposure to chronic stressors and psychological characteristics. Empirical data are also lacking on the association between stress reactivity and cancer control behaviors among African American breast cancer survivors even though prior studies have shown that these women are less likely than whites to engage in health behaviors that are important to cancer control and research is now being conducted to understand how stress affects these behaviors.This research is testing the hypothesis that stress: (1) promotes temporal discounting; (2) has an adverse effect on self-efficacy, and (3) reduces executive functioning (e.g., goal setting, planning). However, stress reactivity, and the association between these responses and cancer control behaviors (e.g., diet, physical activity, and treatment compliance), have not been examined among African American breast cancer survivors. Prior studies have shown that African Americans have a dysregulated stress response as a result of persistent exposure to chronic and acute and stressors; this may alter stress responses and lead to high levels of allostatic load. In order to develop effective behavioral interventions for African American breast cancer survivors, an important first step is to verify that the mechanisms (e.g., temporal discounting, self-efficacy) involved in health behaviors for cancer control (e.g., diet, physical activity, treatment compliance) are associated with stress reactivity among these women. Therefore this study will characterize stress reactivity among African American breast cancer survivors and validate the association between these responses and targeted mechanisms of behavior change.

Blood samples, urine samples, and saliva samples

Due to the nature of this study, only women who were born biologically as female will be eligible to participate in this study. Men who develop breast cancer have a different pathophysiology than women, and therefore, will not be included in this sample.

Stress Reactivity Among African American Breast Cancer Survivors

The Science of Behavior Change in African American Breast Cancer Survivors

Conduct an A Tier Social Stress Test (TSST)with patients to induce a stress response. Cortisol is being examined as a stress biomarker and will be measured at baseline, at multiple timepoints (n=3) during the TSST, and immediately after the TSST to assess changes in cortisol levels.

Collect vital assessments that include heart rate and systolic and diastolic blood pressure at baseline, during the course of the Trier Social Stress Test (TSST), and immediately after the TSST in order to examine changes in vitals as it relates to stress responses during the TSST.

Characterize the nature and distribution of stress reactivity among African American breast cancer survivors based on socioeconomic, clinical, and social stressors. Socioeconomic status will be collected via self-report utilizing household income and education items from the Behavioral Risk Factor Surveillance System (BRFSS) tool. Financial strain will be evaluated using the Comprehensive Score for financial Toxicity (COST) tool. Social stress will be assessed by levels of social isolation using the loneliness scale. Clinical variables relating to disease stage will be extracted from the patient's electronic medical record.

A blood sample will determine circulating levels of neutrophils, lymphocytes, and monocytes to determine glucocorticoid sensitivity.

The Kirby Delay Discounting Task conducted immediately (10 minutes) or longer (20 minutes) following exposure to the Trier Social Stress Test to examine temporal discounting.

Self-reported diet behaviors will be associated with levels of stress reactivity 1-month following stress induction.

Self-reported physical activity behaviors will be associated with levels of stress reactivity 1-month following stress induction.

Medical University of South Carolina

Principal Investigator

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Nervous System Diseases

Symptoms and General Pathology

Heart and Blood Diseases

Musculoskeletal Diseases

Infections

Rare Diseases

Diabetes Mellitus

Depressive Disorder

Syncope

Syncope, Vasovagal

Acute Coronary Syndrome

Syndrome

Fatigue

Hypotension

Depression

Heart Failure

Atrial Fibrillation

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Myocardial Infarction

Infarction

Hypertension

Heart Diseases

Ischemia

Heart Failure, Systolic

Cerebrovascular Disorders

Systolic Murmurs

Fibromyalgia

Myofascial Pain Syndromes

Autonomic Nervous System Diseases

Primary Dysautonomias

Ischemic Attack, Transient

Tachycardia

Fatigue Syndrome, Chronic

Heart Failure, Diastolic

Tachycardia, Sinus

Panic Disorder

Arrhythmias, Cardiac

Necrosis

Vascular Diseases

Muscular Diseases

Rheumatic Diseases

Collagen Diseases

Neuromuscular Diseases

Cardiac Conduction System Disease

Unconsciousness

Consciousness Disorders

Neurobehavioral Manifestations

Neurologic Manifestations

Brain Ischemia

Brain Diseases

Central Nervous System Diseases

Encephalomyelitis

Neuroinflammatory Diseases

Chronic Disease

Disease Attributes

Orthostatic Intolerance

Anxiety Disorders

Mental Disorders

Psychotic Disorders

Tachycardia, Supraventricular

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

Consecutive patients who consult a cardiologist - electrophysiologist since June 2006, regardless of the age or gender in the city of Medellin, Colombia. They could have consulted previously (considered as the enrollment date) if they had, at least, one measurement of their BP in supine position, and an immediate measurement of their BP in standing position that allows diagnosing their group of blood pressure. All patients have a record in paper and/or magnetic file and in OpenClinica.

No interventions.

Luis Eduardo Medina, MD.

Luis E Medina, MD

Jose F Florez, PhD

Jose M Cotes, PhD

The essential arterial hypotension and allostasis registry is a prospective, observational research that has the purpose of demonstrating that essential blood pressure (BP) disorders and the associated comorbidities are a result of the inappropriate allostatic response to daily life stress. This required a functioning brain orchestrating the evaluation of the threat and choosing the response, this is a mind-mediated phenomenon. If the response is excessive it contributes to high BP, if deficient to low BP, and the BP itself will identify the allostatic pattern, which in turn will play an important role in the development of the comorbidities.

To do so, consecutive patients of any age and gender that visit a cardiologist's office in Medellin, Colombia, are recruited. Individuals are classified according to their arterial BP and allostasis and follow them in time to see what kind of diseases develops the most (including BP) in the follow up according to the categorization of the characteristic chosen and after adjustment for confounder's variables. In addition, stress events with their date are registered.

HYPOTHESIS

The causes of the diseases are multifactorial.

Physical, biochemical, psychological, social, and cultural dimensions of development dynamically interact to shape the health development process.

A person´s health depends on their:

1. Biological and physiologic systems
2. External and internal environment (a) physical, b) internal behavioural and arousal state as registered by the brain.
3. Their interaction.

The allostatic mechanisms to the internal and external stressors (allostatic load) involves a network composed by:

1. Functional systems; mediated by:

   1. The Autonomic Nervous System
   2. The endocrine system
   3. The immune system
2. Structural changes: whenever the internal and/or external stressors are long lasting and/or strength enough, they may induce changes in:

   1. Epigenetic, endophenotypes, polyphenism.
   2. Plasticity
3. The interaction between a) and b).

The network response do not affect exclusively the BP, propitiating the development of comorbidities, which may prompt strategies for prevention, recognition and ultimately, treatment.

The allostatic model defines health as a state of responsiveness.

The concept of psycho-biotype: The allostasis is the result of both: biological (allostasis) and psychological (psychostasis) abilities. It is proposed that both components behave in similar direction and magnitude.

Immune disorders may be associated with the development of cancer. High BP population has a higher sympathetic and lower vagal tone, this has been associated with a decrease in the immune´s system function.

Resources and energy depletion: Terms like weathering have been used to describe how exposures to different allostatic loads gradually scrape away at the protective coating that keeps people healthy. It is postulated that High BP individuals have more resources and energy.

Essential Hypotension and Allostasis Registry

Essential Arterial Hypotension and Allostasis Registry

Clinical syncope characteristics (age of first syncope, number of syncope episodes, trauma, duration, clinical score, convulse, sphincter relaxation, etc.) Syncope cause Blood pressure group Adaptability group Prognosis

TTT protocol: describe the protocol, the time at positive response, nitroglycerine use, autonomic and hemodynamic variables.

TTT outcome for syncope: positive or negative TTT other outcomes: 1) Chronotropic incompetence, 2) arterial orthostatic hypotension, 3) carotid hypersensitivity, 4) POTS, 5) IST The relationship between TTT results and Clinical score for syncope in regard to: syncope behaviour and other orthostatic intolerance entities, symptoms and comorbidities.

The relationship between neurally mediated syncope response at the TTT and comorbidities.

EPS variables: AH, AV, CL, sino atrial conduction time (SACT), sinus node recovery time (SNRT), corrected sinus node recovery time (CSNRT), response to Isoproterenol, intrinsic heart rate Diagnosis: control, sick sinus syndrome, IST, chronotropic incompetence at the TTT HR at the ECG HR at the Holter monitoring HR at the TTT HRV at the Holter monitoring Syncope, cardiac or neurally mediated HR at the physical treadmill test Relationship with the blood pressure group Relationship with the adaptability group

Define how the blood pressure group and/or the adaptability group may add to the already known and include in this registry, in the diagnosis of cardiovascular complications as coronary artery disease, cerebrovascular disease, peripheral artery disease, nephropathy.

Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.

Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, COPD, and others.

Mortality

Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.

Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable.

Psychiatric variables:

1. Big Five Questionary (BFQ) for personality.
2. Modify of the Coping Scale (Scale of modified coping strategies)
3. Zung questionary for depression and anxiety
4. MINI in those patients with moderate or severe depression and/or anxiety at the Zung questionary

High sodium intake in the diet is recognized as a risk factor for hypertension development.

Essential hypotension population is advised to increase the sodium (at least 10 grams a day) and water intake (at least 2 liters a day), or as much as possible, several have taken Fludrocortisone (is not a exclusion criteria). Normal blood pressure population are advised to have a normal or low sodium intake. Physical exercise is recommended in both groups.

This registry is a good opportunity to test how important sodium diet is to induce hypertension, or if by the contrary adaptability could prevail over high sodium intake in this registry.

Blood pressure groups: essential hypotension and normotension and those with new essential hypertension. Adaptability groups.

The results will be adjusted for age, gender and BMI.

Consistent bradycardia in the ECG at the office and normal HR in the holter monitoring or the contrary.

There are patients with complaints that may be attributed to bradycardia, low blood pressure, hypothyroidism, or other entities.

Some patients very often have bradycardia in the ECG taken in the office and normal HR in the 24 Holter monitoring, the opposite is also possible.

Patients with bradycardia (without medication or physiological condition as exersice affecting heart rate) in at least 2 ECG (less 60 bpm) and at least 2 Holter monitoring will be analyzed,

Other variables to consider are:

Age, gender, blood pressure group, adaptability group, maximum HR in the treadmill test, white coat or masked hypertension, Tilt-Table-test result or syncope cause, Electrophysiological study if available.

The acknowledge of this phenomenon could have clinical implications in the diagnosis of sick sinus syndrome and physiopathological ones.

Bradycardia is the classical presentation form for sinus node dysfunction, mainly when associated with symptoms. Chronotropic incompetence is also a manifestation. Absence of medications with effects on the heart rate (HR) must be ruled out.

Variables

1. HR at the ECG, Holter monitoring, stress text, and at the physical examination previous to pacemaker implantation,
2. Electrophysiological study (EPS): Basic cycle length, Sino-atrial conduction time, Sinus node recovery time, Corrected sinus node recovery time, Intrinsic HR when available 3. Pacemaker variables: HR at day and night or rest time Percentage of stimulation in A and V chambers 4. Syncope: Clinical characteriscs and clinical score Tilt table test results Trans Thoracic Echocardiogram in rest and or stress text Hypothesis: patients with ANSD will start to decrease the percentage atrial stimulation.

A non invasive, beat to beat BP monitoring, with the ability to measure BP, HR, Cardiac Output and Systemic Vascular Resistance (SVR) was started to use in the EHAR registry since May 2017. A description of this variables in the three BP groups will be collected in the data base (DB).

This will allow to characterize whether SVR and/or CO maintain BP. Until now BP levels are related with prognosis. In the prognosis model SVR and CO will be add them to know what matter the most: BP levels, SVR and/or CO? In the EHAR registry a collection of the variables recognized as a risk factor for several comorbidities are available to adjust in multivariable analysis.

Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.

Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others.

Cardiovascular mortality Total mortality

Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others.

Cardiovascular mortality Total mortality

Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.

Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others.

Cardiovascular mortality Total mortality

Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.

Habits: smoke and drink

Anthropometric variables: Body mass index, waist, hip

Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, homoeostasis model assessment (HOMA), total cholesterol, LDL, HDL, triglycerides.

Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone

Electrocardiogram: HR; PR interval, QRS complex, cQT interval

Holter variables: HR, standard deviation of NN intervals (SDNN) and sympathovagal balance, at day, night and 24 hs.

ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.

Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.

Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable.

Habits: smoke and drink

Anthropometric variables: Body mass index, waist, hip

Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides.

Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone

Electrocardiogram: PR interval, QRS complex, Heart rate, cQT interval

Holter variables: HR, SDNN and sympathovagal balance, at day, night and 24 hs.

ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.

Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.

Adaptability group: 1) Hyper adaptable, 2) normal adaptability and 3) hypo adaptable.

Habits: smoke and drink, exercise

Anthropometric variables: Body mass index, waist, hip

Metabolic and other variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides; thyrotropine,

Holter variables: HR, standard deviation of NN intervals (SDNN) and sympathovagal balance, at day, night and 24 hs.

ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.

Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable.

Habits: smoke and drink Anthropometric variables: Body mass index, waist, hip

Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides.

Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone

Electrocardiogram: PR interval, QRS complex, Heart rate, cQT interval

Holter variables: HR, SDNN and sympathovagal balance, at day, night and 24 hs.

ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Stress Reactivity Among African American Breast Cancer Survivors	NCT03881085	Breast Cancer F... Stress Reaction		21 Years - 75 Years	Medical University of South Carolina
Essential Hypotension and Allostasis Registry	NCT02018497	Blood Pressure Depression Panic Attack Fibromyalgia POTS Inappropriate S... Coronary Heart ... Acute Coronary ... Acute Myocardia... Cerebrovascular... Transient Ische... Atrial Fibrilla... Diabetes Mellit... Cancer Systolic Heart ... Diastolic Heart... Chronic Fatigue... Syncope Vasovagal Synco...		-	CES University

Spots Global Cancer Trial Database for allostatic load