Heart and Blood Diseases

All Conditions

Symptoms and General Pathology

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Coronary Artery Disease

Myocardial Ischemia

Ischemia

Lung Neoplasms

Arrhythmias, Cardiac

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Heart Diseases

Vascular Diseases

Jahangir A Khan, MD, PhD

Kati Helleharju, RC

Jahangir Khan, MD, PhD

Jahangir Khan

Lung cancer surgery causes significant changes in the small circulation as well as changes in the intrathoracic anatomy. The effects of lung cancer surgery on electrocardiography and the cardiac stress associated with the procedures have not been previously extensively studied. The aim of the present study is to ascertain whether modern mini-invasive lung cancer surgery causes changes in the electrocardiogram, and whether these changes are transitory during short-term follow-up. Furthermore, the study aims to describe whether lung cancer surgery causes significant cardiac stress detectable by intraoperative electrocardiography.

Lung cancer surgery causes significant acute changes in the small circulation as well as both transient and permanent changes in the intrathoracic anatomy. The electrocardiographic changes as well as their associations with postoperative recovery associated with modern mini-invasive lung cancer surgery have not been extensively studied.

The aims of the study are:

1. To define in detail the electrocardiographic changes and their duration caused by lung cancer surgery, both perioperatively and in the early postoperative period
2. To assess, whether perioperative electrocardiographic changes are associated with the postoperative recovery of these patients.

Altogether 100 patients with planned mini-invasive lung cancer surgery in the Tays Heart Hospital, Tampere, Finland, will be prospectively recruited for the study between the years 2021 and 2028.

The 12-lead rest electrocardiogram will be recorded from each patient preoperatively as well daily postoperatively and during follow-up out-patient clinic visit two weeks postoperatively. The perioperative continuous multi-lead electrocardiogram will be recorded. Laboratory examinations (cardiac troponins and natriuretic peptides) indicating cardiac stress will be obtained from the patients preoperatively and repeatedly postoperatively. The variables included in the electrocardiography analysis include cardiac rhythm, heart rate variability, PQ-time, QRS duration, P-, QRS, and T-wave amplitudes and axles, as well as ST-level variations.

Postoperative complications, including cardiac arrhythmias and myocardial ischemia and the duration of postoperative air leak and postoperative chest tube drainage, will be recorded. The associations between lung cancer surgery and electrocardiographic changes, their duration, as well as their associations with postoperative recovery will be analyzed using statistical methods.

A local study registry will be established for the study adhering to the legislature and protocols for clinical studies, including data security. Institutional ethics board committee approval has been obtained. The study will be registered in ClinicalTrials.gov prior to patient enrollment. The study does not include any interventions beside the normal treatment of these patients. Written informed consent will be obtained from each patient. The results of the study will be published in international medical journals.

The Cardiac Stress and Electrocardiographic Changes Caused by Lung Cancer Surgery

The Cardiac Stress and Electrocardiographic Changes Caused by Lung Cancer Surgery.

Amplitude changes in the 12-lead rest electrocardiography in millimeters, analyzed daily postoperatively.

The duration of the QRS-complex in milliseconds in the electrocardiogram, measured daily postoperatively using 12-lead rest electrocardiogram.

Changes in the PQ-delay in milliseconds in the 12-lead rest electrocardiogram measured daily postoperatively.

The duration of QT-interval in milliseconds in the 12-lead rest electrocardiogram measured daily postoperatively.

New complete or partial bundle branch blocks, such as RBBB, in the 12-lead rest electrocardiogram.

ST-level changes in millimeters in the 12-lead rest electrocardiogram

The occurrence and type of P-wave, QRS-complex, and T-wave axle changes in the postoperative 12-lead rest electrocardiogram

Postoperative heart rate variability in continuous electrocardiographic monitoring

Arrhythmia rate as well as their type during the early postoperative period detected by continuous electrocardiogram monitoring

The occurrence, duration (in minutes) as well as the magnitude (in millimeters) of perioperative ST-elevation or depression in the continuous perioperative electrocardiographic monitoring.

Heart rate levels perioperatively in the continuous perioperative electrocardiographic monitoring.

The occurrence and type of perioperative arrhythmias, such as atrial fibrillation or flutter, or ventricular tachycardia in the perioperative electrocardiographic monitoring.

The amplitude (in millimeters) of possible R- and T-wave amplitude changes in the perioperative electrocardiographic monitoring.

The presence and duration of (in days) postoperative air leak

Need for reoperation due to for example bleeding.

Tampere University Hospital

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Digestive System Diseases

Breast Neoplasms

Osteoporosis

Coronary Disease

Colonic Neoplasms

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Breast Diseases

Skin Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Micronutrients

All Drugs and Chemicals

Bone Density Conservation Agents

Vitamins

Hormones

Estrogens

Vitamin D

Cholecalciferol

Calcium

Progestins

Calcium, Dietary

Trace Elements

Hormone Antagonists

Vitamin D3

Calciferol

hormone replacement therapy

estrogens

progestins

estrogen replacement therapy

diet, fat-restricted

calcium

vitamin D

dietary supplements

Ross Prentice

To address cardiovascular disease, cancer, and osteoporosis, the most common causes of death, disability, and impaired quality of life in postmenopausal women. The three major components of the WHI are: a randomized controlled clinical trial of hormone replacement therapy (HRT), dietary modification (DM), and calcium/vitamin D supplementation (CaD); an observational study (OS); and a community prevention study (CPS). On October 1, 1997, administration of the WHI was transferred to the NHLBI where it is conducted as a consortium effort led by the NHLBI in cooperation with the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Cancer Institute (NCI), and the National Institute on Aging (NIA).

BACKGROUND:

Prior to 1991, little research had focused on health issues unique to, or more common for, women. This was especially the case for studies of chronic diseases and their prevention in mature women. These conditions (coronary heart disease, cancer, and osteoporosis) are the leading causes of impairment of quality of life, morbidity, and mortality in post-menopausal United States women. The WHI, mandated by Congress, was established in 1991 by the National Institutes of Health and located in the Office of the Director (OD). The Clinical Coordinating Center for the clinical trial/observational study was funded in September 1992 and the 16 Vanguard Clinical Centers were funded in March 1993. The initial protocol was developed jointly by the Clinical Coordinating Center and the Program Office and was reviewed and approved by the Investigators Committee on April 20, 1993. Additional clinical centers were funded in 1994.

On October 1, 1997, administration of the WHI was transferred to the NHLBI where it is conducted as a consortium effort led by the NHLBI in cooperation with the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Cancer Institute (NCI), and the National Institute on Aging (NIA).

DESIGN NARRATIVE:

As has been described in the objective, the WHI has three major components: a randomized controlled clinical trial, an observational study, and a study of community approaches to developing healthful behaviors. Recruitment for the WHI began in September 1993 and ended in December 1998. Six clinical centers completed recruitment in January 1997. The remaining 34 centers completed recruitment in December 1998.

CLINICAL TRIAL COMPONENT

The clinical trial component consists of three subtrials: the hormone replacement trial, the dietary modification trial, and the calcium /vitamin D supplementation trial. Approximately 27,500 women aged 50 to 79 are participating in the HRT, which tests whether long-term HRT reduces coronary heart disease and fractures without increasing breast cancer risk. Women with a uterus were randomized to receive either estrogen plus progestin or a placebo. Progestin was added to protect women with a uterus from endometrial cancer. Women who have had a hysterectomy were randomized to receive either estrogen alone or a placebo. The estrogen plus progestin trial was stopped early on July 8, 2002 after an average follow-up of 5.2 years on the recommendation of the Data and Safety Monitoring Board. The estrogen alone study continued unchanged until March 2, 2004 when the NIH instructed participants to stop taking their study pills and to begin the follow-up phase of the study. . Participants in the estrogen alone study will be followed for eight to 12 years and have clinic visits every six months to assure safety and assess their health.

The dietary modification trial component studies the effect of a low-fat, high fruit, vegetable and grain diet on breast cancer, colorectal cancer and heart disease in 48,000 postmenopausal women. Participants are randomized to a comparison group which maintains usual dietary habits or to a dietary change group. Women in the dietary change group decrease their fat intake to 20 percent of total daily calories, increase fruit and vegetable consumption to five or more servings per day, and increase grains to six or more servings per day. Additionally, they monitor their food intake and attend nutrition group meetings to learn more about changing their diets in the first year. Thereafter they attend four meetings per year.

The calcium/vitamin D supplementation subtrial tests whether calcium and vitamin D supplements reduce the risk of hip and other fractures and colorectal cancer in postmenopausal women. Women in the hormone replacement therapy and the dietary modification trials are encouraged to join the calcium/vitamin D supplementation study. Approximately 45,000 postmenopausal women are randomized into one of two study groups. One group was randomly assigned to receive 1,000 mg of elemental calcium (as calcium carbonate) and 400 International Units of vitamin D₃daily. The second group received a matching placebo.

Women already taking calcium supplements can continue to take them. Participants will be followed for eight to 11 years and contacted by their clinical center every six months to assure their safety and assess their health.

Total number of trial participants in all three subtrials is 68,135.

OBSERVATIONAL STUDY

The several goals of the study include: to give reliable estimates of extent to which known risk factors predict heart disease, cancers, and fractures; to identify new risk factors for these and other diseases in women; to compare risk factors, presence of disease at the start of the study and new occurrences of disease during the WHI in all study components; and to create a future resource to identify biological indicators of disease, especially substances and factors found in blood. The study enrolled 93,726 postmenopausal women and will track them for an average of nine years. Participants fill out periodic health forms and visit the clinic three years after enrollment. They take no medication and do not change their health habits.

COMMUNITY PREVENTION STUDY

The community prevention study consists of 12 separate studies conducted at eight of the Centers for Disease Control and Prevention's (CDC) University-based Prevention Research Centers through a cooperative agreement between NIH and CDC. The 12 studies began in October 1995 and continue for an additional five years. The collaboration supports health promotion and disease prevention research and demonstration projects that are community-based and focus on healthy behaviors that prevent the major causes of death and disability and that promote health practices that lead to more effective public health interventions. Each project provides research dissemination and translation of findings into community interventions. Topics under study include: attitudes towards hysterectomy, oophorectomy, and surgical menopause among African Americans; reducing cardiovascular disease risk among Black women; environmental and policy interventions to increase physical activity among minority women ages 40 to 75; peer support intervention for cardiovascular disease risk among African American women, aged 40 and older; assessing the effectiveness of a brief medical-provider educational intervention for osteoporosis in minority women aged 40 and older; improving the delivery of diabetes care to women in minority groups; and assessment of moderate physical activity among women.

Women's Health Initiative (WHI)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Cancer Institute (NCI)

National Institute on Aging (NIA)

National Heart, Lung, and Blood Institute (NHLBI)

Nervous System Diseases

Ganglion Cysts

Angina Pectoris

Synovial Cyst

Cysts

Arteriosclerosis

Arterial Occlusive Diseases

Pain

Chest Pain

Neurologic Manifestations

Mucinoses

Connective Tissue Diseases

Patients will undergo radiosurgery of the ganglion stellatum (left one or both)

Patients will undergo radiosurgery of ganglion stellatum (left one or both)

Radiosurgery of ganglion stellatum

Jiří Hynčica

Jakub Cvek, Assoc.Prof.,MD,Ing.,PhD

Lukáš Knybel, Ing.,PhD

Miroslav Hudec, MD

Otakar Jiravský, MD

The core hypothesis to be tested is that the radiosurgery of stellate ganglion (left one or both if left-sided without full relief of symptoms) is an effective therapy of refractory angina pectoris in patients with no other therapeutic options - proof of concept study.

Design: prospective, interventional trial (University Hospital Ostrava, Cardiocentre AGEL Podlesi Hospital Trinec)

* radiosurgery of left GS after confirmation of responding to anesthetic blockade
* in case of remaining AP after three months, radiosurgery of right GS in case of response confirmation to anesthetic blockade (patients must be responders of anesthetic blockade of left stellate ganglion)
* Seattle Angina Questionary (SAQ) and amount of nitrate usage for responding confirmation
* Radiotherapy 40 Gy
* 2-year follow-up
* Scheduled follow-up visits: 1, 3, 6, 12, and 24 months (24)

Preliminary examination: selective coronary angiography, transthoracic echocardiography, stress test, 6 min walk test, SAQ (19-item)

Endopoints:

Primary Endpoints: SAQ, safety of the radiosurgery of GS Secondary Endpoints:usage decrease of angina relief drugs, 6 min walk test improvement

Follow-up visits examination, Restage: 6 min walk test, SAQ, amount of nitrate usage, ECG, blood tests incl. NT-proBNP, NSE

Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris

Individual participant data may be made available upon request.

The Seattle Angina Questionnaire is a cardiac disease-related quality-of-life measure with 19 items. A lower score corresponds to a lower level of functioning. The scores are classified as "minimal (scores 75-100), mild (50-74), moderate (25-49), and severe (0-24).

Safety of radiosurgery of ganglion stellatum will be observed and assessed according to the occurrence of adverse events

The change of angina pectoris relief drugs will be evaluated

Change in the six-minute walk test will be evaluated before and after the procedure

Nemocnice AGEL Trinec-Podlesi a.s.

University Hospital Ostrava

Myocardial Infarction

Infarction

Cerebrovascular Disorders

Necrosis

Brain Diseases

Central Nervous System Diseases

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

Aspirin

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Antioxidants

Protective Agents

Tocopherol

Tocotrienol

Vitamin E (600 IU every other day) and aspirin (100 mg every other day)

Vitamin E (600 IU every other day) and placebo

Aspirin (100 mg every other day) and placebo

Participants will receive 100 mg of aspirin every other day.

Participants will receive 600 IU of vitamin E every other day.

Placebo

Julie Buring

The purpose of this study is to evaluate the effects of low-dose aspirin and vitamin E in primary prevention of cardiovascular disease and cancer in apparently healthy women.

BACKGROUND:

Various doses of aspirin have been shown to be effective in preventing thrombosis or vascular occlusion in several clinical conditions. Short-term studies have documented the efficacy of aspirin in preventing occlusion of saphenous vein bypass grants, preventing myocardial infarction in patients with unstable angina, preventing transient ischemic attacks and stroke in men with cerebral vascular disease, preventing occlusion of injured coronary arteries following transluminal angioplasty and aiding in reducing myocardial infarction and total mortality in patients receiving fibrinolytic therapy. Additionally, aspirin has been effective in the secondary prevention of myocardial infarction in subjects with known coronary artery disease. The results of the Physicians' Health Study, a large-scale primary prevention trial of aspirin in male physicians, have shown a decrease in myocardial infarction, a non-significant increase in cerebral vascular events, and no difference in overall mortality. However, few studies have addressed the efficacy of aspirin in vascular diseases in women, and it is possible that the risk to benefit ratio may be different in women. Specifically, there have been no large primary prevention trials in women, who are at risk of coronary heart disease, especially after menopause.

DESIGN NARRATIVE:

The Women's Health Study (WHS) is a randomized, double-blind, placebo-controlled trial using a 2x2 factorial design. The WHS is sponsored by both NHBLI (HL080467) and NCI (CA047988). Approximately 1.75 million female health professionals were contacted by mail to determine if they were suitable for inclusion in the study. A three-month run-in phase was performed to screen out those with poor compliance. Randomization, which began in February 1993 and ended in January 1996, was stratified on five-year age groups. A total of 39,876 participants were randomly assigned to either Vitamin E (600 IU every other day) or placebo; and to aspirin (100 mg every other day) or placebo. IN the 2x2 factorial design, women were randomly assigned to active aspirin and placebo vitamin E (n=9,968), placebo aspirin and active vitamin E (n=9,971), active aspirin and active vitamin E (n=9,966), or placebo aspirin and placebo vitamin E (n=9,971). A description of the characteristics of women in these 4 groups is provided in J Women's Health Gend Based Med 2000;9:19-27. In the main analyses, all women on active aspirin (n=19,934) were compared to women on placebo aspirin (n=19,942); and all women on active vitamin E (n=19,937) were compared to women on placebo aspirin (n=19,939).

As part of the initial trial, pre-randomization blood samples from 28,345 participants were frozen and stored for genetic analysis which has been supported by non-federal sources.

The primary endpoint is the reduction of the risk of all important vascular events (a combined endpoint of nonfatal myocardial infarction, nonfatal stroke, and total cardiovascular death) and a decrease in the incidence of total malignant neoplasms of epithelial cell origin. Secondary endpoints are the individual components of the combined endpoints. Compliance is measured by replies to a questionnaire sent out every year. The trial was completed in 2004 and results were published in 2005 (N Engl J Med 2005;352:1293-304; JAMA 2005;294:47-55; JAMA 2005;294:56-65).

Currently, women are being followed on an observational basis.

Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer

Women's Health Study of Low-dose Aspirin and Vitamin E in Apparently Healthy Women

Brigham and Women's Hospital

Professor of Medicine, Harvard Medical School

Aspirin(100 mg every other day)and placebo vitamin E

Aspirin Only

Placebo aspirin and vitamin E (600 IU every other day

Vitamin E Only

Aspirin (100 mg every other day) and vitamin E (600 IU every other day)

Aspirin + Vitamin E

Both Placebos

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Julie E. Buring

Major cardiovascular event

Stroke

Myocardial infarction

Cardiovascular death

Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Cardiac Stress and Electrocardiographic Changes Caused by Lung Cancer Surgery	NCT05094843	Lung Cancer Surgery Arrhythmia Myocardial Isch...		18 Years -	Tampere University Hospital
Women's Health Initiative (WHI)	NCT00000611	Bone Diseases Breast Neoplasm... Cardiovascular ... Colonic Neoplas... Coronary Diseas... Heart Diseases Myocardial Isch... Osteoporosis Postmenopause	hormone replace... estrogens progestins estrogen replac... diet, fat-restr... calcium vitamin D dietary supplem...	50 Years - 79 Years	National Heart, Lung, and Blood Institute (NHLBI)
Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris	NCT05600751	Coronary Artery... Angina Pectoris Myocardial Isch...	Radiosurgery of...	18 Years -	University Hospital Ostrava
Women's Health Initiative (WHI)	NCT00000611	Bone Diseases Breast Neoplasm... Cardiovascular ... Colonic Neoplas... Coronary Diseas... Heart Diseases Myocardial Isch... Osteoporosis Postmenopause	hormone replace... estrogens progestins estrogen replac... diet, fat-restr... calcium vitamin D dietary supplem...	50 Years - 79 Years	National Heart, Lung, and Blood Institute (NHLBI)
Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer	NCT00000479	Cardiovascular ... Cerebrovascular... Coronary Diseas... Heart Diseases Myocardial Infa... Myocardial Isch... Vascular Diseas...	Aspirin Vitamin E Placebo	45 Years -	Brigham and Women's Hospital
The Cardiac Stress and Electrocardiographic Changes Caused by Lung Cancer Surgery	NCT05094843	Lung Cancer Surgery Arrhythmia Myocardial Isch...		18 Years -	Tampere University Hospital
Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer	NCT00000479	Cardiovascular ... Cerebrovascular... Coronary Diseas... Heart Diseases Myocardial Infa... Myocardial Isch... Vascular Diseas...	Aspirin Vitamin E Placebo	45 Years -	Brigham and Women's Hospital

Spots Global Cancer Trial Database for myocardial ischemia