Post-conditioning to Reduce Infarct Size

NCT ID: NCT00755469

Last Updated: 2013-12-05

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

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-08-31

Brief Summary

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When angioplasty (PTCA) and stenting of the blood vessels of the heart is the treatment for a Heart Attack, there is damage to the heart muscle that is caused by the sudden opening of the blood vessels. This is called "reperfusion injury". The cell death is due to inflammation and the generation of free radicals.

The primary objective of this study is to determine if post-conditioning(four brief (30 second) PTCA balloon inflations) reduces damage to the heart muscle. This will be measured by heart enzyme tests-CK measurements- and by cardiac MRI.

Detailed Description

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Conditions

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Myocardial Infarction

Keywords

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Reperfusion injury Post-Conditioning Infarct size

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

Post-conditioning

Intervention Type PROCEDURE

The post-conditioning protocol consists of performing 4, 30-second PTCA balloon occlusions followed by 30 seconds of reperfusion for a total of 4 minutes. The first balloon inflation occurs immediately after an angioplasty guidewire is placed through the obstruction in the artery and flow is restored. Following this protocol the vessel will be stented as part of usual practice for treatment of acute MI.

Interventions

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Post-conditioning

The post-conditioning protocol consists of performing 4, 30-second PTCA balloon occlusions followed by 30 seconds of reperfusion for a total of 4 minutes. The first balloon inflation occurs immediately after an angioplasty guidewire is placed through the obstruction in the artery and flow is restored. Following this protocol the vessel will be stented as part of usual practice for treatment of acute MI.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 \< 80
* Able to give informed consent
* 100% occlusion of a major epicardial vessel with TIMI 0 Flow

Exclusion Criteria

* Significant collateral blood flow to the distal vasculature of the occluded vessel.
* Previous CABG
* Previous q-wave myocardial infarction in the same territory
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Society for Cardiovascular Angiography and Interventions

OTHER

Sponsor Role collaborator

Minneapolis Heart Institute Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jay H Traverse, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Heart Institute at Abbott Northwestern Hospital

Locations

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Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Traverse JH, Wang YL, Chavez, IJ, Lesser JR, Pedersen WR, Mirheydar H, Henry TD. Post Conditioning reduces infarct size and improves LV function during acute myocardial infarction. Circulation 2006;114:II-344.

Reference Type BACKGROUND

Staat P, Rioufol G, Piot C, Cottin Y, Cung TT, L'Huillier I, Aupetit JF, Bonnefoy E, Finet G, Andre-Fouet X, Ovize M. Postconditioning the human heart. Circulation. 2005 Oct 4;112(14):2143-8. doi: 10.1161/CIRCULATIONAHA.105.558122. Epub 2005 Sep 26.

Reference Type BACKGROUND
PMID: 16186417 (View on PubMed)

Garcia S, Henry TD, Wang YL, Chavez IJ, Pedersen WR, Lesser JR, Shroff GR, Moore L, Traverse JH. Long-term follow-up of patients undergoing postconditioning during ST-elevation myocardial infarction. J Cardiovasc Transl Res. 2011 Feb;4(1):92-8. doi: 10.1007/s12265-010-9252-0. Epub 2010 Dec 7.

Reference Type RESULT
PMID: 21136310 (View on PubMed)

Related Links

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http://www.mplsheart.org

The Minneapolis Heart Institute Foundation improves cardiovascular health through clinical research and education

Other Identifiers

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opt002

Identifier Type: -

Identifier Source: org_study_id