N/A
N=300
Electrophysiological Effects of Late PCI After MI
Cardiovascular Diseases · Heart Diseases · Myocardial Infarction · Coronary Disease · Arrhythmia
Bottom Line
View on ClinicalTrials.gov: NCT00119847 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Short-termed Fractal Scaling Exponent (Alpha 1) — 0.01; -0.03 unit-less — p=0.34
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PCI (Procedure); Optimal Medical Therapy (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Dec 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short-termed Fractal Scaling Exponent (Alpha 1) |
0.01; -0.03 | 0.34 |
| SECONDARY T-wave Variability |
-6.3; -3.4 | 0.45 |
| SECONDARY Filtered QRS Duration |
1.5; 3.7 | 0.23 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00119847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.