NCT00005671

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. 1.Demographic Information Sheet -General information such as age, marital status, employment, education, and history of cardiac medical procedures.
  2. 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. 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. 4.Angina Survey - Information on the frequency of chest pain, chest tightness, or angina.
  5. 5.Symptom Distress Survey - Patient's ranking of the degree of symptom distress from chest discomfort, difficulty breathing, heart rate irregularities, wheezing and coughing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2000

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2002

Completed
Last Updated

March 4, 2008

Status Verified

May 1, 2002

First QC Date

May 24, 2000

Last Update Submit

March 3, 2008

Conditions

Keywords

AnginaCondition SpecificHeart FailureSymptom DistressRevascularizationCoronary Artery DiseaseIschemic Heart Disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Known coronary artery disease. Left ventricular ejection fraction less that or equal to 45%. Signed informed consent. Must be able to read written English.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Lukkarinen H. Quality of life in coronary artery disease. Nurs Res. 1998 Nov-Dec;47(6):337-43. doi: 10.1097/00006199-199811000-00007.

    PMID: 9835489BACKGROUND
  • 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.

    PMID: 8888661BACKGROUND
  • 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.

    PMID: 1399662BACKGROUND

MeSH Terms

Conditions

Myocardial IschemiaAngina PectorisHeart FailureCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 24, 2000

First Posted

May 25, 2000

Study Start

May 1, 2000

Study Completion

May 1, 2002

Last Updated

March 4, 2008

Record last verified: 2002-05

Locations