Viewing Study NCT00119847



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Study NCT ID: NCT00119847
Status: COMPLETED
Last Update Posted: 2022-05-18
First Post: 2005-07-06

Brief Title: Electrophysiological Effects of Late PCI After MI
Sponsor: University of Maryland Baltimore
Organization: University of Maryland Baltimore

Study Overview

Official Title: Electrophysiological Effects of Late PCI OAT-EP
Status: COMPLETED
Status Verified Date: 2022-05
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: The purpose of this study is to determine if opening blocked arteries with heart balloons and stents prevents heart rhythm problems in individuals 3 to 28 days after a heart attack
Detailed Description: BACKGROUND

There is now unequivocal evidence that early coronary reperfusion using either thrombolytics or primary angioplasty results in a long-term mortality reduction among individuals who have had a heart attack The benefit of early reperfusion less than 6 hours after the heart attack was initially attributed to myocardial salvage and the resultant preservation of left ventricular function However it is now known that the survival benefit associated with thrombolytic therapy is not consistently associated with a major improvement in left ventricular ejection fraction LVEF These observations led to the formulation of the late open artery hypothesis which suggests that clinical outcomes can potentially be improved by late reperfusion after a heart attack Observational clinical studies have suggested that late patency of the infarct-related artery IRA after thrombolysis is associated with a survival benefit that is independent of LVEF and therefore cannot be solely explained by salvage of myocardium Definitive proof of the late open artery hypothesis is currently lacking however because previous studies that have evaluated late percutaneous transluminal coronary angioplasty PTCA of occluded IRAs after a heart attack have produced conflicting results

These findings led to the organization of the Occluded Artery Trial OAT an international NHLBI-funded randomized trial of 2200 participants OAT is testing the hypothesis that mechanical reperfusion of an occluded IRA with PTCA and percutaneous coronary intervention PCI 3 to 28 days after a heart attack in high-risk individuals will reduce mortality recurrent heart attacks and hospitalization for class IV congestive heart failure Enhancement of electrical stability is one of the major mechanisms that has been proposed to explain the association of an open IRA with an improved prognosis independent of myocardial salvage

DESIGN NARRATIVE

This study is an ancillary study of OAT It will characterize the effects of late PCI of occluded IRAs on the most important and clinically relevant noninvasive markers of vulnerability to malignant ventricular arrhythmias heart rate variability T wave variability and signal-averaged electrocardiography These analyses will be performed in 300 participants at baseline 30 days and 1 year following a heart attack in order to determine the effects of late PCI on the autonomic nervous system ventricular repolarization and ventricular conduction abnormalities

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HL072906 NIH None httpsreporternihgovquickSearchR01HL072906