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Quality of Life in Patients With Chronic Ischemic Heart Disease

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00005671
First received: May 24, 2000
Last updated: March 3, 2008
Last verified: May 2002
  Purpose

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
Ischemic Heart Disease
Myocardial Ischemia

Study Type: Observational
Official Title: Quality of Life in Chronic Ischemic Heart Disease With Left Ventricular Dysfunction

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 105
Study Start Date: May 2000
Estimated Study Completion Date: May 2002
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005671

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

Publications:
ClinicalTrials.gov Identifier: NCT00005671     History of Changes
Other Study ID Numbers: 000131, 00-CC-0131
Study First Received: May 24, 2000
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on November 20, 2014