Delayed Postconditioning (PRIME)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01483755
First received: November 30, 2011
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Myocardial Reperfusion Injury
Procedure: Postconditioning
Procedure: Percutaneaous intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Delayed Angioplasty Postconditioning in STEMI Patients

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Size of the infarct [ Time Frame: Day 5 post reperfusion ] [ Designated as safety issue: Yes ]
    Size of the infarct estimated by magnetic resonance imaging at day 5 post-reperfusion


Secondary Outcome Measures:
  • Contractile functional recovery [ Time Frame: 6 months after reperfusion ] [ Designated as safety issue: Yes ]
    Contractile functional recovery estimated by echocardiography at 6th month versus before discharge.


Enrollment: 72
Study Start Date: July 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Postconditionned
36 postconditionned patients
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.
Sham Comparator: Conventional intervention
36 control patients with conventional primary percutaneaous intervention (PCI)
Procedure: Percutaneaous intervention
Conventional primary percutaneaous intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483755

Locations
France
Service de Cardiologie, CHU d'Angers
Angers, France, 49933
Service d'explorations Fonctionnelles Cardiovasculaires, Hôpital Cardiologique Louis Pradel
Bron, France, 69677
Service de Cardiologie, Hôpital Arnaud de Villeneuve
Montpellier Cedex 5, France, 34295
Service de Cardiologie, Hôpital Emile Müller
Mulhouse, France, 68051
Service de Cardiologie, Hôpital Rangueil
Toulouse, France, 31059
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided by Hospices Civils de Lyon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01483755     History of Changes
Other Study ID Numbers: 2008.536/37
Study First Received: November 30, 2011
Last Updated: July 26, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Myocardial infarction
Postconditioning

Additional relevant MeSH terms:
Myocardial Reperfusion Injury
Reperfusion Injury
Wounds and Injuries
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014