Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000533
Status:
COMPLETED
Last Update Posted:
2015-12-29
First Post:
1999-10-27
Brief Title:
Montreal Heart Attack Readjustment Trial M-HART
Sponsor:
McGill University
Organization:
McGill University
Study Overview
Official Title:
Montreal Heart Attack Readjustment Trial M-HART
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 1376 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
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 andor 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 1376 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL047330 | NIH | None | httpsreporternihgovquickSearchR01HL047330 |