Montreal Heart Attack Readjustment Trial (M-HART)
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Heart Diseases
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
social support
Sponsored by
About this trial
This is an interventional trial for Cardiovascular Diseases
Eligibility Criteria
Men and women myocardial infarction patients.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000533
First Posted
October 27, 1999
Last Updated
December 28, 2015
Sponsor
McGill University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000533
Brief Title
Montreal Heart Attack Readjustment Trial (M-HART)
Official Title
Montreal Heart Attack Readjustment Trial (M-HART)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
February 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 1996 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
McGill University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To examine the impact of a monitoring and social support intervention upon survival of myocardial infarction patients.
Detailed Description
BACKGROUND:
Despite evidence that social support and various aspects of negative affect may influence prognosis after a myocardial infarction, the impact of psychosocial supportive interventions had not been demonstrated. Further, little was known about the impact of psychosocial and/or interventions among women patients. Previous work by Nancy Frasure-Smith and colleagues suggested that a one-year post-myocardial infarction program of monthly telephone monitoring of psychological stress symptoms, coupled with home nursing visits for patients reporting high stress levels, had an impact on one-year cardiac mortality and long-term myocardial infarction recurrences among men. However, methodological difficulties prevented drawing firm conclusions. A trial which corrected for these difficulties was conducted involving 948 post-myocardial infarction patients. However, the project was too small to study enough patients to assess program impact separately for men and women. The trial was supported by Canadian sources. The NHLBI supplemented the study in order to expand the sample size from 948 patients to 1,376 patients to allow gender analysis.
DESIGN NARRATIVE:
Randomized, with a multi-hospital design. At the time of discharge from the hospital following a documented myocardial infarction, patients were randomized to treatment and control groups. The control group received usual care from their physicians. In addition to usual care, treatment patients were phoned monthly and responded to a standardized index of psychological symptoms of stress. Those with high stress levels received home nursing visits to reduce their stress. Patients in both groups took part in three interviews: in the hospital, at three months, and at one year post-discharge. Interviews assessed depression, anxiety, anger, self-perceived stress, social support, medication compliance, and cardiac risk factors. Salivary cortisol, a physiological indicator of stress, was assessed on the evening following each interview. Indicators of residual myocardial infarction, ischemia, and arrhythmias were obtained from hospital charts. Outcome data were obtained from hospital charts, death certificates, and Quebec Medicare data and were blindly classified by study cardiologists.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
7. Study Design
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
social support
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Men and women myocardial infarction patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Frasure-Smith
Organizational Affiliation
McGill University
12. IPD Sharing Statement
Citations:
PubMed Identifier
8542512
Citation
Frasure-Smith N. The Montreal Heart Attack Readjustment Trial. J Cardiopulm Rehabil. 1995 Mar-Apr;15(2):103-6. doi: 10.1097/00008483-199503000-00002. No abstract available.
Results Reference
background
PubMed Identifier
9274583
Citation
Frasure-Smith N, Lesperance F, Prince RH, Verrier P, Garber RA, Juneau M, Wolfson C, Bourassa MG. Randomised trial of home-based psychosocial nursing intervention for patients recovering from myocardial infarction. Lancet. 1997 Aug 16;350(9076):473-9. doi: 10.1016/S0140-6736(97)02142-9.
Results Reference
background
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Montreal Heart Attack Readjustment Trial (M-HART)
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