Balloon Catheters and Stents to Prevent Heart Rhythm Irregularities in Individuals Post-Heart Attack

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00119847
Recruitment Status : Unknown
Verified February 2006 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was:  Active, not recruiting
First Posted : July 14, 2005
Last Update Posted : February 23, 2006
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

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 Drug: Beta Adrenergic Blockers Drug: Platelet Inhibitors Drug: ACE Inhibitors Procedure: PTCA and/or Stents Not Applicable

Detailed Description:


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.


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)
Enrollment : 300 participants
Primary Purpose: Treatment
Official Title: Electrophysiologic Effects of Late PCI (OAT-EP)
Study Start Date : September 2002

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Short-termed fractal scaling exponent (alpha 1) (measured at Year 1)

Secondary Outcome Measures :
  1. Temporal variability in time
  2. Temporal variability in amplitude
  3. Filtered QRS duration
  4. Composite OAT clinical outcome of death, heart attack, and development of class IV congestive heart failure (measured at Year 1)

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT00119847

United States, Maryland
University of Maryland Baltimore Professional Schools
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: Eric J. Rashba, MD University of Maryland Baltimore Professional Schools

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00119847     History of Changes
Other Study ID Numbers: 221
R01HL072906 ( U.S. NIH Grant/Contract )
First Posted: July 14, 2005    Key Record Dates
Last Update Posted: February 23, 2006
Last Verified: February 2006

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Ventricular Fibrillation
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Arterial Occlusive Diseases
Arrhythmias, Cardiac
Adrenergic Agents
Angiotensin-Converting Enzyme Inhibitors
Adrenergic Antagonists
Adrenergic beta-Antagonists
Platelet Aggregation Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors