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Delayed Postconditioning (PRIME)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status and phase

Completed
Phase 2

Conditions

Myocardial Reperfusion Injury

Treatments

Procedure: Percutaneaous intervention
Procedure: Postconditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT01483755
2008.536/37

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

Postconditionned
Experimental group
Description:
36 postconditionned patients
Treatment:
Procedure: Postconditioning
Conventional intervention
Sham Comparator group
Description:
36 control patients with conventional primary percutaneaous intervention (PCI)
Treatment:
Procedure: Percutaneaous intervention

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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