Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005216
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2000-05-25
Brief Title:
Multicenter Study of Silent Myocardial Ischemia MSSMI
Sponsor:
University of Rochester
Organization:
University of Rochester
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 silent myocardial ischemia was associated with an increased risk of cardiac mortality and morbidity during a one to three year follow-up in patients with coronary heart disease
Detailed Description:
BACKGROUND
Reports of unsuspected frequent and prolonged episodes of asymptomatic ST depression ASTD raised important issues for the evaluation and treatment of coronary disease The traditional role of angina as the best indicator of myocardial ischemia had to be reevaluated since several studies had shown that ASTD was much more frequent than symptomatic ischemia in many patients with coronary disease If ASTD reflected clinically meaningful ischemia then overt angina represented only 25 percent of the total ischemic burden Moreover incomplete data suggested that an increased and clinically unsuspected risk might be conferred on a patient with frequent episodes of ASTD In 1988 studies were already in progress to find the most effective drug for treating ASTD If no increased risk was associated with asymptomatic myocardial ischemia there was little value in pursuing further investigations into its detection and therapy But if the risk was increased the detection and treatment of asymptomatic as well as symptomatic myocardial ischemia might completely alter therapy and the outlook for patients with coronary disease The information in 1988 on the increased risk of ASTD was unfortunately scattered and sparse
DESIGN NARRATIVE
A total of 973 patients were enrolled two to six months after hospitalization for an acute coronary event Patients were derived from geographically dispersed centers to enhance generalization of the results to the overall population at risk Ambulatory 24-hour Holter electrocardiographic recordings were used to evaluate the frequency severity and duration of asymptomatic ST depression ASTD as a marker of silent myocardial ischemia during usual daily activities This information was analyzed in conjunction with ST segment depression on treadmill exercise reversible myocardial perfusion defects on stress thallium testing and a limited number of prespecified clinical parameters to assess the contribution which ASTD added to prognostic information from then current diagnostic techniques used to evaluate myocardial ischemia Patients were seen by the study coordinator every four months during the first year then every six months thereafter At each visit the study coordinator interviewed patients to determine interim history functional status symptoms and drug usage At the four month visit a second 24-hour Holter recording was obtained At the 12-month visit and at study termination 12-lead electrocardiograms were recorded and sent to the ECG Core Laboratory for analysis Data analyses were used to assess the predictive usefulness and independence of ASTD in ambulatory patients with established coronary heart disease to evaluate the interactions and associations between the frequency severity and duration of ASTD and other measures of myocardial ischemia to obtain insight into suspected vasoactive and increased myocardial oxygen consumption mechanisms of myocardial ischemia to better understand the interrelationship between myocardial ischemia and ventricular arrhythmias as it related to subsequent cardiac mortality and morbidity
The study was renewed in 1993 for one year in order to fully analyze the prospectively accumulated data on the 973 enrolled patients in the Multicenter Study of Silent Myocardial Ischemia MSSMI The primary goal was to determine the usefulness or the lack thereof of ambulatory electrocardiographic AECG monitoring for identifying coronary patients with jeopardized ischemic myocardium at risk for ischemic cardiac events The aims of the study were 1 to evaluate the reproducibility of then current methods for detecting ischemic-type changes ST depression on AECG 2 to improve the accuracy and reliability of contemporary scanner-interactive methodology that had been utilized for identifying ischemic-type ST-segment changes on the AECG 3 to complete the development on a new innovative and reproducible computer-based technique for automatic operator-independent quantitative identification of beat-to-beat ischemic-type ST depression on the MSSMI AECG tapes 4 to evaluate the clinical utility of the improved and new ST-segment analytic techniques to identify coronary patients at risk for natural cardiac events unstable angina non-fatal myocardial infarction and cardiac death during two year follow-up in the overall MSSMI population in selected subgroups gender age and in prespecified high-risk ischemic subsets and 5 to determine the optimal cost- effective strategy for sequencing the assessment of silent jeopardized ischemic myocardium by clinical variables and non-invasive tests to identify coronary patients at risk for subsequent ischemic cardiac events This research utilized statistical techniques for evaluating reproducibility of detecting ST depression on AECG kappa statistics analyses of variance Cochrans Q-test for determining ischemic risk factors for time-to-cardiac events Cox regression analyses and for cost-effectiveness analyses receiver-operator characteristic curves
Twenty-four clinical centers In United States Canada Israel and Japan participated in the study There were also an ECG Core Lab an Exercise Core Lab a Holter Core Lab a Thallium Core Lab and a Coordinating Center
Reports of unsuspected frequent and prolonged episodes of asymptomatic ST depression ASTD raised important issues for the evaluation and treatment of coronary disease The traditional role of angina as the best indicator of myocardial ischemia had to be reevaluated since several studies had shown that ASTD was much more frequent than symptomatic ischemia in many patients with coronary disease If ASTD reflected clinically meaningful ischemia then overt angina represented only 25 percent of the total ischemic burden Moreover incomplete data suggested that an increased and clinically unsuspected risk might be conferred on a patient with frequent episodes of ASTD In 1988 studies were already in progress to find the most effective drug for treating ASTD If no increased risk was associated with asymptomatic myocardial ischemia there was little value in pursuing further investigations into its detection and therapy But if the risk was increased the detection and treatment of asymptomatic as well as symptomatic myocardial ischemia might completely alter therapy and the outlook for patients with coronary disease The information in 1988 on the increased risk of ASTD was unfortunately scattered and sparse
DESIGN NARRATIVE
A total of 973 patients were enrolled two to six months after hospitalization for an acute coronary event Patients were derived from geographically dispersed centers to enhance generalization of the results to the overall population at risk Ambulatory 24-hour Holter electrocardiographic recordings were used to evaluate the frequency severity and duration of asymptomatic ST depression ASTD as a marker of silent myocardial ischemia during usual daily activities This information was analyzed in conjunction with ST segment depression on treadmill exercise reversible myocardial perfusion defects on stress thallium testing and a limited number of prespecified clinical parameters to assess the contribution which ASTD added to prognostic information from then current diagnostic techniques used to evaluate myocardial ischemia Patients were seen by the study coordinator every four months during the first year then every six months thereafter At each visit the study coordinator interviewed patients to determine interim history functional status symptoms and drug usage At the four month visit a second 24-hour Holter recording was obtained At the 12-month visit and at study termination 12-lead electrocardiograms were recorded and sent to the ECG Core Laboratory for analysis Data analyses were used to assess the predictive usefulness and independence of ASTD in ambulatory patients with established coronary heart disease to evaluate the interactions and associations between the frequency severity and duration of ASTD and other measures of myocardial ischemia to obtain insight into suspected vasoactive and increased myocardial oxygen consumption mechanisms of myocardial ischemia to better understand the interrelationship between myocardial ischemia and ventricular arrhythmias as it related to subsequent cardiac mortality and morbidity
The study was renewed in 1993 for one year in order to fully analyze the prospectively accumulated data on the 973 enrolled patients in the Multicenter Study of Silent Myocardial Ischemia MSSMI The primary goal was to determine the usefulness or the lack thereof of ambulatory electrocardiographic AECG monitoring for identifying coronary patients with jeopardized ischemic myocardium at risk for ischemic cardiac events The aims of the study were 1 to evaluate the reproducibility of then current methods for detecting ischemic-type changes ST depression on AECG 2 to improve the accuracy and reliability of contemporary scanner-interactive methodology that had been utilized for identifying ischemic-type ST-segment changes on the AECG 3 to complete the development on a new innovative and reproducible computer-based technique for automatic operator-independent quantitative identification of beat-to-beat ischemic-type ST depression on the MSSMI AECG tapes 4 to evaluate the clinical utility of the improved and new ST-segment analytic techniques to identify coronary patients at risk for natural cardiac events unstable angina non-fatal myocardial infarction and cardiac death during two year follow-up in the overall MSSMI population in selected subgroups gender age and in prespecified high-risk ischemic subsets and 5 to determine the optimal cost- effective strategy for sequencing the assessment of silent jeopardized ischemic myocardium by clinical variables and non-invasive tests to identify coronary patients at risk for subsequent ischemic cardiac events This research utilized statistical techniques for evaluating reproducibility of detecting ST depression on AECG kappa statistics analyses of variance Cochrans Q-test for determining ischemic risk factors for time-to-cardiac events Cox regression analyses and for cost-effectiveness analyses receiver-operator characteristic curves
Twenty-four clinical centers In United States Canada Israel and Japan participated in the study There were also an ECG Core Lab an Exercise Core Lab a Holter Core Lab a Thallium Core Lab and a Coordinating Center
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 |
|---|---|---|---|
| R01HL038702 | NIH | None | httpsreporternihgovquickSearchR01HL038702 |