Delayed Postconditioning

NCT ID: NCT01483755

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Reperfusion Injury

Keywords

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Myocardial infarction Postconditioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Postconditionned

36 postconditionned patients

Group Type EXPERIMENTAL

Postconditioning

Intervention Type PROCEDURE

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.

Conventional intervention

36 control patients with conventional primary percutaneaous intervention (PCI)

Group Type SHAM_COMPARATOR

Percutaneaous intervention

Intervention Type PROCEDURE

Conventional primary percutaneaous intervention

Interventions

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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.

Intervention Type PROCEDURE

Percutaneaous intervention

Conventional primary percutaneaous intervention

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Cardiologie, CHU d'Angers

Angers, , France

Site Status

Service d'explorations Fonctionnelles Cardiovasculaires, Hôpital Cardiologique Louis Pradel

Bron, , France

Site Status

Service de Cardiologie, Hôpital Arnaud de Villeneuve

Montpellier, , France

Site Status

Service de Cardiologie, Hôpital Emile Müller

Mulhouse, , France

Site Status

Service de Cardiologie, Hôpital Rangueil

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 24585265 (View on PubMed)

Other Identifiers

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2008.536/37

Identifier Type: -

Identifier Source: org_study_id