NCT01208727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

Same day

First QC Date

September 23, 2010

Last Update Submit

December 13, 2025

Conditions

Keywords

Myocardial infarctionPostconditioningMicrovascular obstructionNo reflowMRI

Outcome Measures

Primary Outcomes (1)

  • 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

    5 days

Secondary Outcomes (1)

  • Size of the myocardial infarction

    5 days

Study Arms (2)

Control

NO INTERVENTION

22 controls patients without post conditionment

Intervention

EXPERIMENTAL

22 posconditioned patients

Procedure: postconditioning

Interventions

Direct postconditioning (brief repeated cycle of 4 occlusion and desocclusion of the initially occluded culprit coronary artery) after primary direct stenting.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Myocardial Reperfusion InjuryMyocardial Infarction

Interventions

Ischemic Postconditioning

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesReperfusion InjuryPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsInfarctionIschemiaNecrosis

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Pierre CROISILLE, MD

    Hospices Civils de Lyon

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2010

First Posted

September 24, 2010

Study Start

April 1, 2009

Primary Completion

April 1, 2009

Study Completion

March 1, 2011

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations