Status:
COMPLETED
Electrophysiological Effects of Late PCI After MI
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Heart Diseases
Eligibility:
All Genders
Phase:
NA
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00119847
Start Date
September 1 2002
End Date
December 1 2006
Last Update
May 18 2022
Active Locations (1)
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1
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794