Electrophysiological Effects of Late PCI After MI

NCT ID: NCT00119847

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2006-12-31

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 2,200 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.

Conditions

Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Arrhythmia; Ventricular Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PCI+MED

Percutaneous Coronary Intervention (PCI) with angioplasty and stenting of the infarct-related artery and optimal medical therapy

Group Type: EXPERIMENTAL

PCI

Intervention Type: PROCEDURE

Optimal Medical Therapy

Intervention Type: DRUG

Guideline-directed drug therapies after MI

MED

Optimal medical therapy alone

Group Type: EXPERIMENTAL

Optimal Medical Therapy

Intervention Type: DRUG

Guideline-directed drug therapies after MI

Interventions

PCI

Intervention Type: PROCEDURE

Optimal Medical Therapy

Guideline-directed drug therapies after MI

Intervention Type: DRUG

Other Intervention Names

Angioplasty and stenting of the infarct-related artery

Eligibility Criteria

Inclusion Criteria

• Has experienced a heart attack 3 to 28 days prior to study entry
• Persistently occluded IRA defined as either: 1) Thrombolysis in Myocardial Infarction (TIMI) 0, with no flow beyond the site of occlusion; or 2) TIMI 1, with penetration of dye beyond the site of occlusion without dye reaching the distal vessel
• LVEF less than 50% or proximal occlusion in a large vessel
• Normal sinus rhythm
• QRS duration less than 120 ms
• Able to return for follow-up assessment of arrhythmia markers one month and one year after study entry

Exclusion Criteria

• Has a clinical indication for revascularization (post-heart attack angina at rest; significant inducible ischemia; or significant left main or triple vessel disease requiring PTCA or CABG)
• Current serious illness or condition that limits 3-year survival
• Severe valvular disease
• Chronic total occlusion
• New York Heart Association Class III-IV congestive heart failure
• Prior left ventricular aneurysm in the recent heart attack location
• Is a poor candidate for PTCA/stent on the basis of angiographic or clinical criteria
• Cannot medically survive anticoagulation during PTCA/stent or antiplatelet therapy after stent
• Pregnant

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Eric Rashba

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric J. Rashba, MD

Role: STUDY_CHAIR

Stony Brook University Medical Center

Locations

Stony Brook University Medical Center

Stony Brook, New York, United States

Countries

United States

References

Rashba EJ. Assessment of ventricular repolarization abnormalities in congenital long QT syndrome. J Cardiovasc Electrophysiol. 2004 May;15(5):557-9. doi: 10.1046/j.1540-8167.2004.04022.x. No abstract available.

Reference Type: BACKGROUND

PMID: 15149425 (View on PubMed)

Rashba EJ. Should T-wave alternans testing be used to risk stratify candidates for prophylactic implantable cardioverter-defibrillator therapy? Heart Rhythm. 2005 Mar;2(3):242-4. doi: 10.1016/j.hrthm.2004.12.015. No abstract available.

Reference Type: BACKGROUND

PMID: 15851311 (View on PubMed)

Rashba EJ, Lamas GA, Couderc JP, Hollist SM, Dzavik V, Ruzyllo W, Fridrich V, Buller CE, Forman SA, Kufera JA, Carvalho AC, Hochman JS; OAT-EP Investigators. Electrophysiological effects of late percutaneous coronary intervention for infarct-related coronary artery occlusion: the Occluded Artery Trial-Electrophysiological Mechanisms (OAT-EP). Circulation. 2009 Feb 17;119(6):779-87. doi: 10.1161/CIRCULATIONAHA.108.808626. Epub 2009 Feb 2.

Reference Type: RESULT

PMID: 19188505 (View on PubMed)

Other Identifiers

R01HL072906

Identifier Type: NIH

Identifier Source: secondary_id

View Link

221

Identifier Type: -

Identifier Source: org_study_id