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Enhancing Recovery in Coronary Heart Disease (ENRICHD) Patients

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ClinicalTrials.gov Identifier: NCT00000557
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : April 14, 2016
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Study Description
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Brief Summary:
To evaluate the effect of psychosocial intervention on mortality and reinfarction in coronary heart disease patients at high psychosocial risk.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Coronary Disease Depression Heart Diseases Myocardial Infarction Myocardial Ischemia Behavioral: social support Phase 3

Detailed Description:

BACKGROUND:

As medical treatments for coronary heart disease have become more sophisticated, they have also become more costly. Evidence concerning the effects of medical and rehabilitative therapies on post-myocardial infarction patients' quality of life, including return to work and to normal levels of functioning, has been mixed. At the same time. recent data suggest that psychosocial factors, such as social isolation and depression, are important predictors of morbidity and mortality in coronary heart disease patients. These studies suggest that interventions which provide psychological support to myocardial infarction patients may enhance both the psychosocial and physical recovery of these patients. To the extent that supportive interventions can be shown to impact favorably on survival and health-related quality of life in myocardial infarction patients, the human and financial costs associated with coronary heart disease can be reduced. The initiative originated in the Working Group on Psychosocial Interventions which met in June 1992.

The initiative was given concept clearance by the October 1993 National Heart, Lung, and Blood Advisory Council. The Request for Proposals was released in September 1994.

DESIGN NARRATIVE:

The study design compared a psychosocial intervention group, in which patients were provided with social and psychological treatment designed to decrease social isolation and depression, with a standard medical care group. The combined endpoint was death and reinfarction, measured for up to 4.5 years following hospital discharge. Secondary endpoints included assessment of health quality of life (HQL).

The protocol was approved in May 1996. Recruitment began in October 1996 and ended on October 31, 1999 with 2,481 patients enrolled.

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Prevention
Study Start Date : September 1995
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women coronary heart disease/myocardial infarction patients, hospitalized for enzyme-documented MI and who are depressed and/or have low social support. Patients must be enrolled with 28 days of the index MI.
Contacts and Locations
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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): NCT00000557


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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OverallOfficial: Diane Catellier University of North Carolina
More Information
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Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: ENRICHD
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
Study Protocol  This link exits the ClinicalTrials.gov site
Manual of Procedures  This link exits the ClinicalTrials.gov site

Publications:

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ClinicalTrials.gov Identifier: NCT00000557    
Other Study ID Numbers: 101
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: January 2008
Additional relevant MeSH terms:
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Cardiovascular Diseases
Myocardial Infarction
Heart Diseases
Coronary Disease
Myocardial Ischemia
 Infarction
Ischemia
Pathologic Processes
Necrosis
Vascular Diseases