Electrophysiological Effects of Late PCI After MI

• ClinicalTrials.gov Identifier: NCT00119847
• Recruitment Status: Completed
• First Posted: July 14, 2005
• Results First Posted: August 23, 2018
• Last Update Posted: November 13, 2019
• Sponsor: University of Maryland, Baltimore
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Eric Rashba, University of Maryland, College Park

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Arrhythmia; Ventricular Fibrillation	Procedure: PCI; Drug: Optimal Medical Therapy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Electrophysiological Effects of Late PCI (OAT-EP)
• Actual Study Start Date: September 2002
• Actual Primary Completion Date: December 2006
• Actual Study Completion Date: December 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: PCI+MED; Percutaneous Coronary Intervention (PCI) with angioplasty and stenting of the infarct-related artery and optimal medical therapy	Procedure: PCI; Other Name: Angioplasty and stenting of the infarct-related artery; Drug: Optimal Medical Therapy; Guideline-directed drug therapies after MI
Experimental: MED; Optimal medical therapy alone	Drug: Optimal Medical Therapy; Guideline-directed drug therapies after MI

Outcome Measures

Primary Outcome Measures :

1. Short-termed Fractal Scaling Exponent (Alpha 1) [ Time Frame: Baseline, one year ]
   Nonlinear measurement of heart rate variability, change between baseline and 1 year is the primary outcome.

Secondary Outcome Measures :

1. T-wave Variability [ Time Frame: Baseline and one year ]
   Variability in T wave morphology, change between baseline and one year
2. Filtered QRS Duration [ Time Frame: Baseline and one year ]
   Signal-averaged ECG

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New York

Stony Brook University Medical Center

Stony Brook, New York, United States, 11794

Sponsors and Collaborators

University of Maryland, Baltimore

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Study Chair: Eric J. Rashba, MD; Stony Brook University Medical Center

More Information

Publications of Results:

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.

Other Publications:

Rashba EJ. Assessment of ventricular repolarization abnormalities in congenital long QT syndrome. J Cardiovasc Electrophysiol. 2004 May;15(5):557-9.

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.

• Responsible Party: Eric Rashba, Associate Professor, University of Maryland, College Park
• ClinicalTrials.gov Identifier: NCT00119847
• Other Study ID Numbers: 221; R01HL072906 ( U.S. NIH Grant/Contract )
• First Posted: July 14, 2005
• Results First Posted: August 23, 2018
• Last Update Posted: November 13, 2019
• Last Verified: November 2019

Keywords provided by Eric Rashba, University of Maryland, College Park:

Stents, myocardial infarction

Additional relevant MeSH terms:

Cardiovascular Diseases; Myocardial Infarction; Heart Diseases; Coronary Disease; Ventricular Fibrillation; Infarction; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Vascular Diseases; Arrhythmias, Cardiac