Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Heart and Blood Diseases

Breast Neoplasms

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Anticoagulants

Bone Density Conservation Agents

Other Dietary Supplements

Calcium

Citric Acid

Sodium Citrate

Calcium, Dietary

Citrate

After signing the informed consent form, patients who meet all eligibility criteria will be enrolled in the Study. After execution of the CT scan the patient will be contacted to discuss the CT scan result. In case of high calcium score values, patients will be performing a cardiological medical examination, ECG, and further diagnostic investigations, as clinically indicated

Each enrolled patient performs:

* preventive clinical cardiology assessment visit, addressed to individualized risk profile assessment and addressed to chest CT scan.
* a blood sampling (1 citrate tube of 5 ml) will be done the same day just the chest CT scan and analyzed locally also for future research of biomarker discovery (single sample, for those patients who agree in ICF)
* CT scan

CT scan and blood sample collection

Daniela Trabattoni, MD

This is a no-profit, national, monocenter, retrospective, and prospective low-intervention study. It is a low-intervention study in terms of diagnostic additional procedure (CT scan). It is planned to recruit a maximum of 100 women diagnosed with early-stage breast cancer and treated with adjuvant breast radiotherapy from 2010 to 2017 at the European Institute of Oncology who meet all the inclusion and exclusion criteria. The aim of the Study is to analyze a population of breast cancer patients treated by adjuvant whole breast radiotherapy to identify the most important cardiovascular (CV) risk factors linked to coronary artery disease (CAD) development, in a cure-without-complications oncology strategy.

In the present study a pre-screening activity is planned, that will be conducted by the European Institute of Oncology (IEO) at the Division of Radiotherapy. It will be done to identify and select from the IEO's database about 100 women diagnosed with early-stage breast cancer and treated with adjuvant breast radiotherapy, from 2010 to 2017, and with a \> 5 years clinical Follow up (FU). All patients, who present pre-specified RT treatment, in terms of radiation exposure, and radiation protocol (IORT excluded as well as previous RT treatments), will be proposed to participate in the Study. The researcher of the IEO will contact by phone each identified patient (eligible patients) to request her interest in participating in the present study and to obtain her availability to be contacted by the Investigator of Centro Cardiologico Monzino (CCM) to define all aspects and activities planned in the protocol.

Patients who meet all eligibility criteria, after signing the informed consent form, at Centro Cardioogico Monzino, will be enrolled in the study. After execution of the CT scan the patient will be contacted to discuss the CT scan result. In case of high calcium score values, patients will be performing a cardiological medical examination, ECG, and further diagnostic investigations, as clinically indicated.

Women diagnosed with early-stage breast cancer and treated with adjuvant breast radiotherapy from 2010 to 2017 at European Institute of Oncology

Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT or Breast Cancer

Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT for Breast Cancer. A Gender-based Preventive Medicine Approach

Coronary calcium (CAC) assessment and its relationship with left-side or right-side breast radiation therapy and previously known cardiovascular risk factors. The quantification of CAC will be performed according to the Agatston score by multiplying the total CAC area in mm2 by a density factor ranging from 1 to 4 (1 for lesions with a density of 130-199 HU; 2 if the lesion has a density of 200-299 HU; 3 for lesions with a density of 300-399 HU; 4 for densities ≥400 HU)

Evaluate circulating markers, mostly related to radiation-induced oxidative stress and correlate them to previous CV events and CT data obtained. Patients will undergo a blood sample withdrawal focused on evaluation of albumin isoforms in human plasma and protein signatures.

Albumin thiolation: Mercaptoalbumin (HSA-SH) and thiolated albumin (+120 ± 2 Da, Thio-HSA) will be detected and their intensities used to calculate the relative abundances. Targeted Proteomics will be performed and relative quantitation will be expressed in Normalized protein expression (NPX), Normalized Protein eXpression, is Olink's arbitrary unit which is in Log2 scale. It is calculated from Ct values and data pre-processing (normalization) is performed to minimize both intra- and inter-assay variation. NPX data allows users to identify changes for individual protein levels across their sample set, and then use this data to establish protein signatures.

Incidence of CV events in relationship to left vs right-side breast radiation

Istituto Europeo di Oncologia

Centro Cardiologico Monzino

Symptoms and General Pathology

Fatigue

Breast cancer patients receiving non-anthracycline or anthracycline chemotherapy Cardiac MRIs will be performed baseline, 3 months (for cancer patients only), and 24 months.

Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, on 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers.

Measurements will be repeated at 3±1, 12±2 and 24±2 months after initiation of chemotherapy treatment.

Non-Cancer Controls Cardiac MRIs will be performed baseline and 24 months. Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers.

Measurements will be repeated at 3±1, 12±2 (after the completion of radiation) and 24±2 months after initiation of baseline activities.

Breast Cancer Patients Cardiac MRIs will be performed baseline, 3 months (for cancer patients only), and 24 months.

Non-Cancer Controls Cardiac MRIs will be performed baseline and 24 months.

Cardiac MRI

Gregory Hundley, MD

This study is being done to see if patients receiving chemotherapy for breast cancer affects the heart, the ability to exercise and fatigue when compared to patients who do not have cancer.

840 women aged ≥18 years old scheduled to receive chemotherapy for Stage I-III breast cancer and a comparison population of 160 women without cancer (1,000 total). Equal numbers of women will be recruited aged \< 52 vs. \> 52. At baseline, innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, on 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers will be collected.

Measurements will be repeated at 3±1, 12±2 and 24±2 months. This study will assess the relevance of pre-existing factors such as age, black/white race, hypertension, smoking (yes/no), diabetes, coronary artery disease, menopause status, CV medications, and physical activity on the study outcomes. Also, this study will assess dynamic change in modifiable CV risk factors (including BMI, blood pressure, serum lipids, serum glucose, physical activity, psychosocial factors, lifestyle behaviors), and the cancer treatment including chemotherapy, radiation therapy, immunotherapy, and surgery.

Understanding and Predicting Breast Cancer Events After Treatment

Understanding and Predicting Breast Cancer Events After Treatment (UPBEAT)

Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.

Serum BNP as a predictor of exercise intolerance

Acquired to determine associations between troponin levels during therapy and the onset of cardiac and vascular dysfunction, exercise capacity, and fatigue.

Participants rate the degree to which each item applies in the past 7 days prior to Baseline using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.

Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.

The exam will measure left ventricular volumes, ejection fraction, myocardial strain/strain rate, mass, mapping, aortic pulse wave velocity and aortic wall thickness. The exam will take 10 - 15 minutes to complete.

The purpose of this test is to find out how far the participant can walk in 6 minutes.

A summed scale asking how often over the prior two weeks four aspects of stress were experienced (1=never to 5=very often)

o weeks four aspects of stress were experienced (1=never to 5=very often)

A 14-item scale used to assess the effect of hostility associated with cardiovascular risk factors.

Minimum Score: 0 Maximum Score: 13 Higher values indicate greater hostility.

SF-36 consists of 36 items measuring the following 8 domains: physical function, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional health problems, and mental health. These 8 domains also provide two summary scores.

Screening questionnaire assessing depressive symptoms during the last week

Main process measure of physical activity participation

Assess time course and risk factors associated with sleep disturbance and fatigue

Minimum Score: Raw: 8, T-score: 28.9 Maximum Score: Raw: 40, T-score: 76.5 Higher values represent greater sleep disturbance.

Measurement of different aspects of cognitive functioning.

PROMIS Applied Cognitive Abilities Short Form 8A

- Minimum Score: Raw: 8, T-score: 27.0 Maximum Score: Raw: 40, T-score: 64.8 Higher values represent better cognition.

Applied Cognition General Concerns Short Form 8A

- Minimum Score: Raw: 8, T-score: 23.3 Maximum Score: Raw: 40, T-score: 62.7 Higher values represent better cognition.

Comprised of six items and will be included as a measure of exercise capacity

Participants will be first asked to stand from a sitting position without using their arms. If they can perform the task, they will then be asked to stand up and sit down five times as quickly as possible. The time to complete the task will be recorded.

Participants will be asked to maintain balance for up to 30 seconds in three positions characterized by a progressive narrowing of the base support.

Participants will be instructed to start at a marked walking course with toes touching the start line and when cued to start, will begin walking at their ususal speed. The time to walk from the starting line to the end of the 4-meter walk will be recorded.

Grip strength is assessed with an isometric handgrip dynamometer while the participant is sitting with the head facing straight ahead. The elbow should be bent at a 90 degree angle and the wrist should be at the mid-prone position.

Range of motion at the shoulder joint will be assessed with shoulder flexion and shoulder abduction with a goniometer.

Independently measures the patient's perception of their health status which includes heart failure symptoms (frequency and burden), physical and social limitations, and how their heart failure impacts their QOL within a 2-week recall period.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Nervous System Diseases

Diabetes Mellitus

Syndrome

Cognitive Dysfunction

Myocardial Infarction

Infarction

Neoplasm Metastasis

Metabolic Syndrome

Angina Pectoris

Angina, Unstable

Ischemia

Necrosis

Heart Diseases

Vascular Diseases

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Pain

Chest Pain

Neurologic Manifestations

Herbal and Botanical

Olive

Dietary Intervention with a Low fat diet: \<30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; \<10% saturated fatty acids)

Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; \<10% saturated fatty acids).

Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; \<10% SAT).

Mediterranean Diet

Low fat diet: \<30% fat (12% MUFA; 6-8%PUFA; \<10% SAT)

Low Fat Diet

Francisco Perez-Jimenez, MD,PhD

The purpose of this study is to compare the effects of the consumption of two different dietary patterns (low fat versus Mediterranean Diet) on the incidence of cardiovascular events of persons with coronary disease.

Randomized clinical trial involving 1002 patients with coronary disease that are undergoing one of two diets in a randomized design (two groups; Mediterranean Diet 502 patients, Low Fat 500 patients) for 7 years. The two diets are: a)Low fat diet: \<30% fat (12-14% monounsaturated fatty acids (MUFA); 6-8% polyunsaturated fatty acid (PUFA) ; \<10% SAT) and b) Mediterranean Diet: \>35% fat (22% MUFA; 6% PUFA ; \<10% SAT).

Primary Objective:

Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death).

Secondary Objectives:

Those related in the Outcome Measures section of this webpage

CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention

Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease

Endothelium response to ischemia in the brachial artery. Area under the curve, flow peak and time to maximum flow will be performed

Influence of genetic data in the development clinical outcomes

Postprandial lipemia study based on oral fat tolerance test depending on clinical and genetic variables

Clinical events not qualifying as primary endpoint nor in the secondary objectives 1 and 2, especially those associated with cardiovascular disease

Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function

Additional secondary objectives will be carried out in light of current and/or future knowledge of ischemic heart disease risk factors, prognostic factors and pathophysiological pathways, and will include, but not be limited to, endothelial function, inflammation, cell biology, molecular biology, proteomics, genetics and epigenetics

Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years.

Data from clinical and/or diagnostic tests will be analyzed

Concentration of LDL cholesterol in blood samples

Comparison of Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL during the study

Study of the metabolism of carbohydrates during the trial

Study of blood pressure in response to the study

Cognitive decline will be evaluated by validated questionnaires

Incidence of cardiac death, myocardial infarction, angina event, coronary revascularization or cardiac transplant, stroke, symptomatic heart failure, or any other clinical manifestation of cardiovascular event.

Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest

Incidence of type 2 Diabetes Mellitus during the study

Clinical features of metabolic disease: Metabolic Syndrome, Metabolic Phenotypes of Obesity or other classifications based on anthropometric features will be assessed during the study

Changes in the percentage of different families of Microbiota will be analyzed during the study, and their impact on clinical events.

Study of relationship between existing or new Arrhythmias on clinical events

Individual apparition of hard cardiovascular events:

* myocardial infarction
* revascularization
* ischemic stroke
* documented peripheral artery disease
* cardiovascular death

Global metabolomics in plasma, as well as techniques targeting specific sets of metabolites such as lipid-based lipid species, protein by proteomics, etc.

Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc

Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc

Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied

Metabolism of advanced glycation end products.

Impact of mineral metabolism on atherosclerosis

Cardiac function studies by Echocardiography at baseline and during the study

Study of endothelial microparticles (vesicles formed from endothelial cells membrane after injury). The quantification of the EPCs and EMPs will be performed by flow cytometry

27. Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function

Hospital Universitario Reina Sofia de Cordoba

Chief of Internal Medicine Unit

Antineoplastic Agents

Anti-Infective Agents

Antirheumatic Agents

Dermatologic Agents

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Central Nervous System Depressants

Everolimus

Cyclosporine

Cyclosporins

Prednisolone

Mycophenolic Acid

Methylprednisolone

Basiliximab

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Calcineurin Inhibitors

Benzocaine

Glycyrrhetinic Acid

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Clotrimazole

Miconazole

Antifungal Agents

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Protective Agents

Antineoplastic Agents, Hormonal

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Tannic Acid

Simulect + cyclosporine + Myfortic + steroid stop at 3 months

Simulect + cyclosporine (decrease dose in one week at month 3 and replace by Everolimus (Certican)) + Myfortic + steroid maintenance

Cyclosporine (Group 1):

basiliximab dose: 1x20 mg IV on Day 0 and 1x20 mg IV on Day 4

Cyclosporine: 8 mg/kg PO given before surgery, followed by 2x4 mg/kg/d. C-0h levels: month 1: 150-250 ng/ml; month 2: 100-200 ng/ml; month 3: withdrawal steroids: 100-150 ng/ml.

C-2h levels: month 1: 900-1100 ng/ml; month 2: 800-1000 ng/ml; month 3: withdrawal steroids: maintain level of 750 ng/ml

Enteric-coated mycophenolate(MPA):720mg PO pre-operatively followed by 1.44 g/day.

Steroids: pre-operatively: 250mg methylprednisolone IV; day 1:125mg IV.

Methylprednisolone:day 2-30:PO 12mg/d; day 31-60:tapered to 8mg/d ,day 61-90 :4mg/d; Month 3:stop

cyclosporine

Everolimus (Group 2):

Basiliximab dose: idem as in group 1

Cyclosporine: first three months idem group 1; month 3: decreased dose by 50%, simultaneously initiate everolimus at a starting dose of 0.75 mg bid.

Once the everolimus blood levels range 6 - 12 ng/ml, cyclosporine will be stopped.

Enteric-coated mycophenolate (MPA) dosing idem as group 1.

Everolimus starting dose: 0.75 mg bid, trough levels: 6-12 ng/ml.

Steroid dosing: idem group 1, but maintained at 4 mg methylprednisolone after day 60.

Jean-Louis Bosmans, MD/PhD

Daniel Abramowicz, MD/PhD

Jacques Sennesael, MD/PhD

Jacques Sennesael, MD

Angelika Jurgens, Study Coord.

Patrick Peeters, MD/PhD

Patrick Peeters, MD

Catherine Bonvoisin, MD/PhD

Catherine Bonvoisin, MD

This study intends to determine whether steroid withdrawal or calcineurin inhibitor withdrawal is superior for graft function and graft survival. Secondary endpoints for this study are: incidence of tumors and cardiovascular events.

The primary objective: To assess if superior graft function (glomerular filtration rate (GFR) difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts of de novo kidney transplant patients treated with Myfortic-everolimus plus steroids compared to Myfortic-cyclosporine.

Methodology:

* A 5-year, multicentre, prospective, randomized, open-label, controlled study

  * Group 1: Simulect + cyclosporine + Myfortic + steroid stop at 3 months
  * Group 2: Simulect + cyclosporine (decrease dose in one week at month 3 and replace by everolimus) + Myfortic + steroid maintenance.
* In both groups MPA AUC monitoring will be done at 5-7 days and at 3 months, to ensure sufficient MPA protection.

Sample size calculations:

A total of 152 patients will be randomized (76 patients per group)

Population:

De novo kidney transplant recipients.

Study duration:

1.5 years inclusion+ follow-up during the first 5 years

Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation

Impact of Cyclosporine or Steroid Withdrawal at 3 Months Post Transplantation on Graft Function, Patient Survival and Cardiovascular Surrogate Markers the First 5 Years After Renal Transplantation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT or Breast Cancer	NCT05775822	Breast Cancer	CT scan and blo...	18 Years - 60 Years	Centro Cardiologico Monzino
Understanding and Predicting Breast Cancer Events After Treatment	NCT02791581	Breast Cancer	Cardiac MRI	18 Years -	Wake Forest University Health Sciences
Understanding and Predicting Breast Cancer Events After Treatment	NCT02791581	Breast Cancer	Cardiac MRI	18 Years -	Wake Forest University Health Sciences
CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention	NCT00924937	Myocardial Infa... Unstable Angina Malignancy Cognitive Decli... Diabetes Mellit... Metabolic Syndr...	Mediterranean D... Low Fat Diet	20 Years - 75 Years	Hospital Universitario Reina Sofia de Cordoba
Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation	NCT00903188	Renal Transplan...	cyclosporine Everolimus	18 Years -	University Hospital, Antwerp
Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT or Breast Cancer	NCT05775822	Breast Cancer	CT scan and blo...	18 Years - 60 Years	Centro Cardiologico Monzino

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