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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00119847
First received: July 6, 2005
Last updated: February 22, 2006
Last verified: February 2006
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
Official Title: Electrophysiologic Effects of Late PCI (OAT-EP)

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

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

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

Estimated Enrollment: 300
Study Start Date: September 2002
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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119847

Locations
United States, Maryland
University of Maryland Baltimore Professional Schools
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Investigators
Study Chair: Eric J. Rashba, MD University of Maryland Baltimore Professional Schools
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00119847     History of Changes
Other Study ID Numbers: 221, R01 HL72906
Study First Received: July 6, 2005
Last Updated: February 22, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Infarction
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
Angiotensin-Converting Enzyme Inhibitors
Adrenergic Antagonists
Adrenergic beta-Antagonists
Platelet Aggregation Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014