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Quality of Life in Patients With Chronic Ischemic Heart Disease

Primary Purpose

Ischemic Heart Disease, Myocardial Ischemia

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Ischemic Heart Disease focused on measuring Angina, Condition Specific, Heart Failure, Symptom Distress, Revascularization, Coronary Artery Disease, Ischemic Heart Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Known coronary artery disease. Left ventricular ejection fraction less that or equal to 45%. Signed informed consent. Must be able to read written English.

Sites / Locations

  • Warren G. Magnuson Clinical Center (CC)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 24, 2000
Last Updated
March 3, 2008
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT00005671
Brief Title
Quality of Life in Patients With Chronic Ischemic Heart Disease
Official Title
Quality of Life in Chronic Ischemic Heart Disease With Left Ventricular Dysfunction
Study Type
Observational

2. Study Status

Record Verification Date
May 2002
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

5. 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. Demographic Information Sheet -General information such as age, marital status, employment, education, and history of cardiac medical procedures. 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. 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. Angina Survey - Information on the frequency of chest pain, chest tightness, or angina. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Myocardial Ischemia
Keywords
Angina, Condition Specific, Heart Failure, Symptom Distress, Revascularization, Coronary Artery Disease, Ischemic Heart Disease

7. Study Design

Enrollment
105 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Warren G. Magnuson Clinical Center (CC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9835489
Citation
Lukkarinen H. Quality of life in coronary artery disease. Nurs Res. 1998 Nov-Dec;47(6):337-43. doi: 10.1097/00006199-199811000-00007.
Results Reference
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PubMed Identifier
8888661
Citation
Konstam V, Salem D, Pouleur H, Kostis J, Gorkin L, Shumaker S, Mottard I, Woods P, Konstam MA, Yusuf S. Baseline quality of life as a predictor of mortality and hospitalization in 5,025 patients with congestive heart failure. SOLVD Investigations. Studies of Left Ventricular Dysfunction Investigators. Am J Cardiol. 1996 Oct 15;78(8):890-5. doi: 10.1016/s0002-9149(96)00463-8.
Results Reference
background
PubMed Identifier
1399662
Citation
Grady KL, Jalowiec A, Grusk BB, White-Williams C, Robinson JA. Symptom distress in cardiac transplant candidates. Heart Lung. 1992 Sep-Oct;21(5):434-9.
Results Reference
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Learn more about this trial

Quality of Life in Patients With Chronic Ischemic Heart Disease

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