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Sponsored by: |
National Institutes of Health Clinical Center (CC) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00005671 |
This study will examine the health-related quality of life in patients being treated for chronic heart disease.
Patients 18 years or older with chronic ischemic heart disease and left ventricular dysfunction enrolled in protocols in the National Heart Lung and Blood Institute's Cardiology Branch may participate in this study.
Participants will complete five questionnaires at 3 separate times during the study-once during hospitalization at the NIH Clinical Center and again at home 6 months and 1 year later. The questionnaires, described below, require a total of about 30 minutes to complete.
All information provided in the questionnaires will be kept confidential. Upon request, patients will be sent a summary of the study results when the study is completed.
Condition |
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Ischemic Heart Disease Myocardial Ischemia |
Study Type: | Observational |
Official Title: | Quality of Life in Chronic Ischemic Heart Disease With Left Ventricular Dysfunction |
Estimated Enrollment: | 105 |
Study Start Date: | May 2000 |
Estimated Study Completion Date: | May 2002 |
A majority of the research in patients with chronic ischemic heart disease and left ventricular dysfunction deals with increasing patient survival rates and years. Very little research has focused on patients' perceptions of living with this chronic debilitating disease. The purpose of this naturalistic, prospective study is to assess the Health Related Quality of Life (HRQOL), anginal symptoms and symptom distress experienced by patients with chronic ischemic heart disease and left ventricular dysfunction. The relationship between underlying cardiac condition, anginal symptoms, symptom distress and HRQOL will be examined. The trend in HRQOL across time versus treatment group will be evaluated. The question, does HRQOL, anginal frequency and symptom distress at baseline predict mortality and cardiac related hospitalization during the year following assessment will also be addressed.
Patients who are enrolled in protocols in the Cardiology Branch of the National Heart Lung and Blood Institute (NHLBI) and diagnosed with chronic ischemic heart disease and left ventricular dysfunction will be asked to participate in this HRQOL study. Patients will complete measures of HRQOL (Medical Outcomes Short Form 36 Survey; Minnesota Living with Heart Failure Questionnaire) and symptom measures (anginal frequency subscale of the Seattle Angina Questionnaire; cardiopulmonary subscale of the Heart Transplant Symptom Checklist). Underlying cardiac condition will be assessed using exercise thallium imaging parameters (METS and perfusion defects) and positron emission tomography (PET) imaging parameter (viability). A sample size of 90 subjects is desired for this study. Data will be analyzed using multivariate statistics. It is expected that this study will provide new information regarding how patients with ischemic heart disease and left ventricular function feel their chronic illness and its corresponding treatment(s) affects their HRQOL.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Known coronary artery disease.
Left ventricular ejection fraction less that or equal to 45%.
Signed informed consent.
Must be able to read written English.
Study ID Numbers: | 000131, 00-CC-0131 |
Study First Received: | May 24, 2000 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00005671 History of Changes |
Health Authority: | United States: Federal Government |
Angina Condition Specific Heart Failure Symptom Distress |
Revascularization Coronary Artery Disease Ischemic Heart Disease |
Coronary Disease Ventricular Dysfunction Heart Failure Heart Diseases Myocardial Ischemia Vascular Diseases |
Angina Pectoris Quality of Life Ventricular Dysfunction, Left Ischemia Coronary Artery Disease |
Ventricular Dysfunction Pathologic Processes Heart Diseases Myocardial Ischemia |
Vascular Diseases Ventricular Dysfunction, Left Cardiovascular Diseases Ischemia |