Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005217
Status:
COMPLETED
Last Update Posted:
2016-01-28
First Post:
2000-05-25
Brief Title:
Intermittent ST Depression and Prognosis After Myocardial Infarction
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-01
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 determine if intermittent ST depression STD had an independent impact on survival among myocardial infarction patients who participated in the Beta-Blocker Heart Attack Trial BHAT
Detailed Description:
BACKGROUND
In 1988 coronary heart disease was the leading cause of death in the United States accounting for some 500000 lives annually The search continued for non-invasive ways of improving risk-detection in the population prior to and after manifest disease Detection of silent ischemia as indicated by the presence of asymptomatic intermittent ST depression detected by ECG monitoring was accomplished by non-invasive means and data analysis was determined with current automated analysis programs However there were insufficient data to assign definite prognostic import to intermittent STD The studies addressing this question were in selected populations and yielded conflicting results This was in part due to the small size of the populations previously studied The size of this studys population permitted examination of additional criteria for ST changes in relation to prognosis A finding that transient ischemia adversely affected prognosis in a large group of patients who had myocardial infarction would therefore give confidence to the medical community in an accessible non-invasive technique to identify those at highest risk This would have an important impact on patient management Impetus would also be given toward studying asymptomatic STD among high risk patients hypertensives hypercholesterolemics smokers and diabetics without clinical coronary heart disease to determine if its presence increased the risk of developing myocardial infarction or sudden death
The BHAT trial was a double-blind randomized trial of the effects of propranolol on survival after acute myocardial infarction The total group numbered 3837 patients aged 30-69 Patients were excluded from the study if they had medical contraindications to propranolol a history of severe congestive heart failure or asthma as an adult or if they had or were likely to undergo cardiac surgery Clinical and personal characteristics and ECG data including the results of 24-hour monitoring from the baseline reference examination were completed while patients were hospitalized prior to randomization Patients were seen at regular intervals and a random sample of 1000 patients had a second 24-hour monitoring at 6 weeks Also at this visit a psychosocial stress questionnaire was completed for 2320 men Patients were followed for a minimum of one and up to three years after index myocardial infarction Official follow-up was terminated at 3 years on the recommendation of the Policy Monitoring Board The main finding of improved survival among patients taking propranolol has been widely reported
DESIGN NARRATIVE
This was a case-control study The main issue examined was whether intermittent STD contributed significantly to mortality when other prognostic variables such as prior myocardial infarction heart failure arrhythmia and diabetes were simultaneously controlled for Using BHAT computer and ECG tapes 326 deaths observed during the BHAT follow up were compared to 326 controls
Substudy I examined the joint impact of psychosocial stress and intermittent STD on survival utilizing records of 200 cases or deaths and 200 controls who had the psychosocial stress interview in the BHAT
Substudy II examined whether propranolol had a favorable impact on STD status from baseline to repeat examination The design of this substudy was prospective One hundred fifty patients treated with propranolol and 150 untreated controls were randomly selected from among the 1000 patients who had repeat 24-hour Holter monitoring at the six week follow-up visit Patients were followed from baseline to repeat monitoring at six weeks with the STD durations at baseline and repeat monitoring being followed for each patient
An univariate substudy examined the prevalence of STD in approximately 180 patients from the substudy II cohort who had completed a psychosocial stress interview in order to determine if elevated psychosocial stress was associated with STD A second univariate substudy examined the effect of diabetes on the prevalence of STD A third univariate substudy examined the effect of STD on the prevalence of arrhythmia
Dr Richard Crow at the University of Minnesota was responsible for the reading of the 24-hour Holter tapes Computer analyses were done at Dalhousie University Halifax Nova Scotia Canada
In 1988 coronary heart disease was the leading cause of death in the United States accounting for some 500000 lives annually The search continued for non-invasive ways of improving risk-detection in the population prior to and after manifest disease Detection of silent ischemia as indicated by the presence of asymptomatic intermittent ST depression detected by ECG monitoring was accomplished by non-invasive means and data analysis was determined with current automated analysis programs However there were insufficient data to assign definite prognostic import to intermittent STD The studies addressing this question were in selected populations and yielded conflicting results This was in part due to the small size of the populations previously studied The size of this studys population permitted examination of additional criteria for ST changes in relation to prognosis A finding that transient ischemia adversely affected prognosis in a large group of patients who had myocardial infarction would therefore give confidence to the medical community in an accessible non-invasive technique to identify those at highest risk This would have an important impact on patient management Impetus would also be given toward studying asymptomatic STD among high risk patients hypertensives hypercholesterolemics smokers and diabetics without clinical coronary heart disease to determine if its presence increased the risk of developing myocardial infarction or sudden death
The BHAT trial was a double-blind randomized trial of the effects of propranolol on survival after acute myocardial infarction The total group numbered 3837 patients aged 30-69 Patients were excluded from the study if they had medical contraindications to propranolol a history of severe congestive heart failure or asthma as an adult or if they had or were likely to undergo cardiac surgery Clinical and personal characteristics and ECG data including the results of 24-hour monitoring from the baseline reference examination were completed while patients were hospitalized prior to randomization Patients were seen at regular intervals and a random sample of 1000 patients had a second 24-hour monitoring at 6 weeks Also at this visit a psychosocial stress questionnaire was completed for 2320 men Patients were followed for a minimum of one and up to three years after index myocardial infarction Official follow-up was terminated at 3 years on the recommendation of the Policy Monitoring Board The main finding of improved survival among patients taking propranolol has been widely reported
DESIGN NARRATIVE
This was a case-control study The main issue examined was whether intermittent STD contributed significantly to mortality when other prognostic variables such as prior myocardial infarction heart failure arrhythmia and diabetes were simultaneously controlled for Using BHAT computer and ECG tapes 326 deaths observed during the BHAT follow up were compared to 326 controls
Substudy I examined the joint impact of psychosocial stress and intermittent STD on survival utilizing records of 200 cases or deaths and 200 controls who had the psychosocial stress interview in the BHAT
Substudy II examined whether propranolol had a favorable impact on STD status from baseline to repeat examination The design of this substudy was prospective One hundred fifty patients treated with propranolol and 150 untreated controls were randomly selected from among the 1000 patients who had repeat 24-hour Holter monitoring at the six week follow-up visit Patients were followed from baseline to repeat monitoring at six weeks with the STD durations at baseline and repeat monitoring being followed for each patient
An univariate substudy examined the prevalence of STD in approximately 180 patients from the substudy II cohort who had completed a psychosocial stress interview in order to determine if elevated psychosocial stress was associated with STD A second univariate substudy examined the effect of diabetes on the prevalence of STD A third univariate substudy examined the effect of STD on the prevalence of arrhythmia
Dr Richard Crow at the University of Minnesota was responsible for the reading of the 24-hour Holter tapes Computer analyses were done at Dalhousie University Halifax Nova Scotia Canada
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 |
|---|---|---|---|
| R01HL039641 | NIH | None | httpsreporternihgovquickSearchR01HL039641 |