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Post Cond No Reflow

Primary Purpose

Myocardial Reperfusion Injury

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
postconditioning
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, Microvascular obstruction, No reflow, MRI

Eligibility Criteria

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

Inclusion Criteria:

  • Patients > 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 IVA or RCA (not CA).
  • Artery guilty with TIMI flow = 0

Exclusion Criteria:

  • cardiac arrest before the angioplasty,
  • Cardiogenic shock
  • Occlusion of the artery circumflex responsible for the infarction
  • Magnetic resonance imaging: contre indication

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

22 controls patients without post conditionment

22 posconditioned patients

Outcomes

Primary Outcome Measures

Extent of the area of microvascular obstruction
Extent of the area of microvascular obstruction defined on post-gadolinium CMR images realized 48-72 hours after admission in each group

Secondary Outcome Measures

Size of the myocardial infarction
Size of the myocardial infarction defined on post-gadolinium CMR images realized 48-72 hours after admission in each group.

Full Information

First Posted
September 23, 2010
Last Updated
May 7, 2013
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01208727
Brief Title
Post Cond No Reflow
Official Title
The POSTCONDITIONING and THE NO REFLOW Phenomenon in Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
March 2011 (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
After having shown that postconditioning allowed a significant 36% reduction of infarct size as assessed by blood levels of myocardial enzymes in acute myocardial patients, the investigators objective is to assess the effect of postconditioning in acute myocardial infarction (AMI) patients on microvascular obstruction lesions defined by cardiac MRI images.

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, Microvascular obstruction, No reflow, MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
22 controls patients without post conditionment
Arm Title
Intervention
Arm Type
Experimental
Arm Description
22 posconditioned patients
Intervention Type
Procedure
Intervention Name(s)
postconditioning
Intervention Description
Direct postconditioning (brief repeated cycle of 4 occlusion and desocclusion of the initially occluded culprit coronary artery) after primary direct stenting.
Primary Outcome Measure Information:
Title
Extent of the area of microvascular obstruction
Description
Extent of the area of microvascular obstruction defined on post-gadolinium CMR images realized 48-72 hours after admission in each group
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Size of the myocardial infarction
Description
Size of the myocardial infarction defined on post-gadolinium CMR images realized 48-72 hours after admission in each group.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients > 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 IVA or RCA (not CA). Artery guilty with TIMI flow = 0 Exclusion Criteria: cardiac arrest before the angioplasty, Cardiogenic shock Occlusion of the artery circumflex responsible for the infarction Magnetic resonance imaging: contre indication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre CROISILLE, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Study Director
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22676937
Citation
Thuny F, Lairez O, Roubille F, Mewton N, Rioufol G, Sportouch C, Sanchez I, Bergerot C, Thibault H, Cung TT, Finet G, Argaud L, Revel D, Derumeaux G, Bonnefoy-Cudraz E, Elbaz M, Piot C, Ovize M, Croisille P. Post-conditioning reduces infarct size and edema in patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2012 Jun 12;59(24):2175-81. doi: 10.1016/j.jacc.2012.03.026.
Results Reference
derived

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Post Cond No Reflow

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