Delayed Postconditioning (PRIME)
This study is currently recruiting participants.
Verified November 2011 by Hospices Civils de Lyon
Sponsor:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01483755
First received: November 30, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
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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.
| Estimated Enrollment: | 72 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483755
Contacts
| Contact: Michel OVIZE, MD, PhD | 472 35 69 08 ext +33 | michel.ovize@chu-lyon.fr |
| Contact: Inesse SAHRAOUI | 472 35 69 08 ext +33 | inesse.sahraoui@chu-lyon.fr |
Locations
| France | |
| Service d'explorations Fonctionnelles Cardiovasculaires, Hôpital Cardiologique Louis Pradel | Recruiting |
| Bron, France, 69677 | |
| Contact: Michel OVIZE, MD, PhD 472 35 69 08 ext +33 michel.ovize@chu-lyon.fr | |
| Principal Investigator: Michel OVIZE, MD, PhD | |
| Service de Cardiologie, Hôpital Arnaud de Villeneuve | Recruiting |
| Montpellier Cedex 5, France, 34295 | |
| Contact: Christophe PIOT, MD | |
| Principal Investigator: Christophe PIOT, MD | |
| Service de Cardiologie, Hôpital Emile Müller | Recruiting |
| Mulhouse, France, 68051 | |
| Contact: Olivier ROTH, MD | |
| Principal Investigator: Olivier ROTH, MD | |
| Service de Cardiologie, Hôpital Rangueil | Recruiting |
| Toulouse, France, 31059 | |
| Contact: Elbaz MEYER, MD | |
| Principal Investigator: Elbaz MEYER, MD | |
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
No publications provided
| 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: | November 30, 2011 |
| 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 Cardiomyopathies Heart Diseases Cardiovascular Diseases |
Myocardial Ischemia Vascular Diseases Postoperative Complications Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013