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Montreal Heart Attack Readjustment Trial (M-HART)
This study has been completed.
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00000533
  Purpose

To examine the impact of a monitoring and social support intervention upon survival of myocardial infarction patients.


Condition Intervention Phase
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Behavioral: social support
Phase III

MedlinePlus related topics: Coronary Artery Disease Heart Attack Heart Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Educational/Counseling/Training, Placebo Control

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: February 1992
Estimated Study Completion Date: December 1996
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Men and women myocardial infarction patients.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000533

Sponsors and Collaborators
Investigators
Investigator: Nancy Frasure-Smith McGill University
  More Information

Publications:
Study ID Numbers: 76
Study First Received: October 27, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00000533  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Infarction
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009