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Electrophysiological Effects of Late PCI After MI

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

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 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

Resource links provided by the National Library of Medicine


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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119847


Locations
United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
University of Maryland
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: Eric J. Rashba, MD Stony Brook University Medical Center

Publications of Results:
Other Publications:
Responsible Party: Eric Rashba, Associate Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT00119847     History of Changes
Other Study ID Numbers: 221
R01HL072906 ( U.S. NIH Grant/Contract )
First Posted: July 14, 2005    Key Record Dates
Results First Posted: August 23, 2018
Last Update Posted: August 23, 2018
Last Verified: July 2018

Keywords provided by Eric Rashba, University of Maryland:
Stents, myocardial infarction

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Ventricular Fibrillation
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Arrhythmias, Cardiac