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Montreal Heart Attack Readjustment Trial (M-HART)
This study has been completed.
Study NCT00000533   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: October 27, 1999   Last Updated: June 23, 2005   History of Changes

October 27, 1999
June 23, 2005
February 1992
 
 
 
Complete list of historical versions of study NCT00000533 on ClinicalTrials.gov Archive Site
 
 
 
Montreal Heart Attack Readjustment Trial (M-HART)
 

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

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.

Phase III
Interventional
Educational/Counseling/Training, Placebo Control
  • Cardiovascular Diseases
  • Coronary Disease
  • Heart Diseases
  • Myocardial Infarction
  • Myocardial Ischemia
Behavioral: social support
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
December 1996
 

Men and women myocardial infarction patients.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00000533
 
76
National Heart, Lung, and Blood Institute (NHLBI)
 
Investigator: Nancy Frasure-Smith McGill University
National Heart, Lung, and Blood Institute (NHLBI)
March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP