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Delayed Postconditioning (PRIME)

Primary Purpose

Myocardial Reperfusion Injury

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Postconditioning
Percutaneaous intervention
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Reperfusion Injury focused on measuring Myocardial infarction, Postconditioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Service de Cardiologie, CHU d'Angers
  • Service d'explorations Fonctionnelles Cardiovasculaires, Hôpital Cardiologique Louis Pradel
  • Service de Cardiologie, Hôpital Arnaud de Villeneuve
  • Service de Cardiologie, Hôpital Emile Müller
  • Service de Cardiologie, Hôpital Rangueil

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Postconditionned

Conventional intervention

Arm Description

36 postconditionned patients

36 control patients with conventional primary percutaneaous intervention (PCI)

Outcomes

Primary Outcome Measures

Size of the infarct
Size of the infarct estimated by magnetic resonance imaging at day 5 post-reperfusion

Secondary Outcome Measures

Contractile functional recovery
Contractile functional recovery estimated by echocardiography at 6th month versus before discharge.

Full Information

First Posted
November 30, 2011
Last Updated
July 26, 2013
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01483755
Brief Title
Delayed Postconditioning
Acronym
PRIME
Official Title
Delayed Angioplasty Postconditioning in STEMI Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Reperfusion Injury
Keywords
Myocardial infarction, Postconditioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Postconditionned
Arm Type
Experimental
Arm Description
36 postconditionned patients
Arm Title
Conventional intervention
Arm Type
Sham Comparator
Arm Description
36 control patients with conventional primary percutaneaous intervention (PCI)
Intervention Type
Procedure
Intervention Name(s)
Postconditioning
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Percutaneaous intervention
Intervention Description
Conventional primary percutaneaous intervention
Primary Outcome Measure Information:
Title
Size of the infarct
Description
Size of the infarct estimated by magnetic resonance imaging at day 5 post-reperfusion
Time Frame
Day 5 post reperfusion
Secondary Outcome Measure Information:
Title
Contractile functional recovery
Description
Contractile functional recovery estimated by echocardiography at 6th month versus before discharge.
Time Frame
6 months after reperfusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Service de Cardiologie, CHU d'Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Service d'explorations Fonctionnelles Cardiovasculaires, Hôpital Cardiologique Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Service de Cardiologie, Hôpital Arnaud de Villeneuve
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Service de Cardiologie, Hôpital Emile Müller
City
Mulhouse
ZIP/Postal Code
68051
Country
France
Facility Name
Service de Cardiologie, Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24585265
Citation
Roubille F, Mewton N, Elbaz M, Roth O, Prunier F, Cung TT, Piot C, Roncalli J, Rioufol G, Bonnefoy-Cudraz E, Wiedemann JY, Furber A, Jacquemin L, Willoteaux S, Abi-Khallil W, Sanchez I, Finet G, Sibellas F, Ranc S, Boussaha I, Croisille P, Ovize M. No post-conditioning in the human heart with thrombolysis in myocardial infarction flow 2-3 on admission. Eur Heart J. 2014 Jul 1;35(25):1675-82. doi: 10.1093/eurheartj/ehu054. Epub 2014 Feb 28.
Results Reference
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Delayed Postconditioning

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