Delayed Postconditioning

Myocardial Reperfusion Injury Clinical Trial

— PRIME  

Official title:

Delayed Angioplasty Postconditioning in STEMI Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483755
• Other study ID #: 2008.536/37
• Status: Completed
• Phase: Phase 2
• First received: November 30, 2011
• Last updated: July 26, 2013
• Start date: July 2009
• Est. completion date: June 2012

Study information

• Verified date: July 2013
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myocardial Reperfusion Injury
• Reperfusion Injury

Intervention

Procedure:
• Postconditioning
Postconditioning consists of four cycles of one minute balloon inflation followed by one minute of balloon deflation, with the initial inflation being started within the first minute after reopening of the culprit coronary artery.
• Percutaneaous intervention
Conventional primary percutaneaous intervention

Locations

Country	Name	City	State
France	Service de Cardiologie, CHU d'Angers	Angers
France	Service d'explorations Fonctionnelles Cardiovasculaires, Hôpital Cardiologique Louis Pradel	Bron
France	Service de Cardiologie, Hôpital Arnaud de Villeneuve	Montpellier Cedex 5
France	Service de Cardiologie, Hôpital Emile Müller	Mulhouse
France	Service de Cardiologie, Hôpital Rangueil	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of the infarct	Size of the infarct estimated by magnetic resonance imaging at day 5 post-reperfusion	Day 5 post reperfusion	Yes
Secondary	Contractile functional recovery	Contractile functional recovery estimated by echocardiography at 6th month versus before discharge.	6 months after reperfusion	Yes