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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
McGill University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Cardiovascular Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Men and women myocardial infarction patients.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    December 28, 2015
    Sponsor
    McGill University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    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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