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Quality of Life in Patients With Chronic Ischemic Heart Disease

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ClinicalTrials.gov Identifier: NCT00005671
Recruitment Status : Completed
First Posted : May 25, 2000
Last Update Posted : March 4, 2008
Information provided by:

Study Description
Brief Summary:

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.

  1. Demographic Information Sheet -General information such as age, marital status, employment, education, and history of cardiac medical procedures.
  2. General Health Survey -Patient's self-assessment, on a rating scale, of physical and emotional well being. Questions are related to the ability to perform work and daily living activities, mood and state of mind, limitations on social activities, energy level, pain level, general quality of life, etc.
  3. Heart Disease Survey - Patient's self-assessment, on a rating scale, of the level of physical, social, emotional and functional well being related to his or her heart condition. Questions concern fatigue level, emotional outlook, social well being, etc.
  4. Angina Survey - Information on the frequency of chest pain, chest tightness, or angina.
  5. Symptom Distress Survey - Patient's ranking of the degree of symptom distress from chest discomfort, difficulty breathing, heart rate irregularities, wheezing and coughing.

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 or disease
Ischemic Heart Disease Myocardial Ischemia

Detailed Description:

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.

Study Design

Study Type : Observational
Estimated Enrollment : 105 participants
Official Title: Quality of Life in Chronic Ischemic Heart Disease With Left Ventricular Dysfunction
Study Start Date : May 2000
Estimated Study Completion Date : May 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005671

United States, Maryland
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
More Information

ClinicalTrials.gov Identifier: NCT00005671     History of Changes
Other Study ID Numbers: 000131
First Posted: May 25, 2000    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: May 2002

Keywords provided by National Institutes of Health Clinical Center (CC):
Condition Specific
Heart Failure
Symptom Distress
Coronary Artery Disease
Ischemic Heart Disease

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases