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Clinical Trials/NCT01483755
NCT01483755
Completed
Phase 2

Delayed Angioplasty Postconditioning in STEMI Patients

Hospices Civils de Lyon5 sites in 1 country72 target enrollmentJuly 1, 2009

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Myocardial Reperfusion Injury
Sponsor
Hospices Civils de Lyon
Enrollment
72
Locations
5
Primary Endpoint
Size of the infarct
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

The investigators previously reported that angioplasty postconditioning reduces infarct size (cardiac enzyme release) in STEMI patients with a fully occluded coronary artery at hospital admission. Animal studies have suggested that the time window for applying brief episodes of ischemia and reperfusion aimed at triggering postconditioning's protection is very narrow, i.e. does not expand beyond 1 minute after reflow. We sought to address whether this window might be larger in humans, i.e. whether STEMI patients might be protected several minutes after undergoing spontaneous reperfusion before admission coronary angiography.

Therefore, STEMI patients (onset of chest pain less than 12 hours) with a TIMI flow grade > 1 were eligible for that study. Angioplasty postconditioning was completed as already published and infarct size was assessed by measuring cardiac enzymes release.

Registry
clinicaltrials.gov
Start Date
July 1, 2009
End Date
June 1, 2012
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient \> 18 years old
  • Male or female
  • Presenting first myocardial infarction, with the beginning of pains \< 12 hours,
  • Requiring a revascularisation by primary angioplasty or " rescue " (after failure of thrombolysis) on LAD or RCA (not Circumflex coronary artery).
  • TIMI flow grade at admission of 2 or 3
  • LV angiography (RAO30°) before angioplasty.

Exclusion Criteria

  • Cardiac arrest before the angioplasty
  • Cardiogenic shock
  • Occlusion of the artery circumflex responsible for the infarction
  • Visible collaterals to the area at risk
  • Magnetic resonance imaging: contra indication

Outcomes

Primary Outcomes

Size of the infarct

Time Frame: Day 5 post reperfusion

Size of the infarct estimated by magnetic resonance imaging at day 5 post-reperfusion

Secondary Outcomes

  • Contractile functional recovery(6 months after reperfusion)

Study Sites (5)

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