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Delayed Postconditioning (PRIME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01483755
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : July 29, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Myocardial Reperfusion Injury Procedure: Postconditioning Procedure: Percutaneaous intervention Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Delayed Angioplasty Postconditioning in STEMI Patients
Study Start Date : July 2009
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Contractile functional recovery [ Time Frame: 6 months after reperfusion ]
    Contractile functional recovery estimated by echocardiography at 6th month versus before discharge.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 1, 2011    Key Record Dates
Last Update Posted: July 29, 2013
Last Verified: July 2013

Keywords provided by Hospices Civils de Lyon:
Myocardial infarction
Postconditioning

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