NCT01483755

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2009

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

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

July 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

2.9 years

First QC Date

November 30, 2011

Last Update Submit

December 13, 2025

Conditions

Myocardial Reperfusion Injury

Keywords

Myocardial infarctionPostconditioning

Outcome Measures

Primary Outcomes (1)

  • Size of the infarct

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

    Day 5 post reperfusion

Secondary Outcomes (1)

  • Contractile functional recovery

    6 months after reperfusion

Study Arms (2)

Postconditionned

EXPERIMENTAL

36 postconditionned patients

Procedure: Postconditioning

Conventional intervention

SHAM COMPARATOR

36 control patients with conventional primary percutaneaous intervention (PCI)

Procedure: Percutaneaous intervention

Interventions

PostconditioningPROCEDURE

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.

Postconditionned
Percutaneaous interventionPROCEDURE

Conventional primary percutaneaous intervention

Conventional intervention

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Service de Cardiologie, CHU d'Angers

Angers, 49933, France

Location

Service d'explorations Fonctionnelles Cardiovasculaires, Hôpital Cardiologique Louis Pradel

Bron, 69677, France

Location

Service de Cardiologie, Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Service de Cardiologie, Hôpital Emile Müller

Mulhouse, 68051, France

Location

Service de Cardiologie, Hôpital Rangueil

Toulouse, 31059, France

Location

Related Publications (1)

  • 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.

    PMID: 24585265RESULT

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 Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2011

First Posted

December 1, 2011

Study Start

July 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

FR(5)