Postconditioning in the Treatment of Acute ST-segment Elevation Myocardial Infarction

NCT ID: NCT00507156

Last Updated: 2016-10-06

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

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Brief Summary

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Standard treatment of patients with acute ST-segment elevation myocardial infarction consist of acute re-opening of the occluded coronary artery (primary PCI). Despite successful treatment of the epicardial vessel reperfusion is sometimes inadequate leading to large final infarct sizes. This phenomenon is known as the reperfusion injury. Several animal studies have indicated that graded re-opening of the artery may limit tissue damage. Generally this is referred to as mechanical postconditioning.

The study investigates the effect on final infarct size evaluated by magnetic resonance scan of postconditioning of ST-segment elevation myocardial infarctions. Mechanical postconditioning is performed by means of several balloon inflations in the injured vessel following its acute re-opening.

Detailed Description

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Please see above

Conditions

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ST-segment Myocardial Infarction

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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Mek postcon

Re-opening of the infarcted coronary artery by several balloon inflations separated by reperfusion of the vessel.

Group Type EXPERIMENTAL

Mechanical postconditioning

Intervention Type PROCEDURE

Mechanical postconditioning with 4 cycles 30/30 sek balloon inflations

Standard treatment

Standard treatment (primary PCI)

Group Type ACTIVE_COMPARATOR

Standard primary PCI

Intervention Type PROCEDURE

Acute re-opening of the occluded coronary artery

Interventions

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Standard primary PCI

Acute re-opening of the occluded coronary artery

Intervention Type PROCEDURE

Mechanical postconditioning

Mechanical postconditioning with 4 cycles 30/30 sek balloon inflations

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients more than 18 years
* STEMI \< 12 hours
* TIMI 0-1 in infarct related artery

Exclusion Criteria

* Multivessel disease (stenoses in non-infarct related arteries \>70%)
* Cardiogenic shock
* Left main occlusions
* Lesions that cannot be treated with stents
* Previous CABG
* Pregnancy
* Severe renal insufficiency
* Previous extensive Q-wave infarction
* LBBB
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Thomas Engstrom

Chief Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Engstrom, D.Sci., PhD

Role: STUDY_CHAIR

Cheif Consultant

Locations

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Cardiac Catherization Lab., Heart Center, Rigshospitalet, University of Copenhagen

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Lonborg J, Holmvang L, Kelbaek H, Vejlstrup N, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Treiman M, Jensen JS, Engstrom T. ST-Segment resolution and clinical outcome with ischemic postconditioning and comparison to magnetic resonance. Am Heart J. 2010 Dec;160(6):1085-91. doi: 10.1016/j.ahj.2010.09.026.

Reference Type DERIVED
PMID: 21146662 (View on PubMed)

Lonborg J, Kelbaek H, Vejlstrup N, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Holmvang L, Treiman M, Jensen JS, Engstrom T. Cardioprotective effects of ischemic postconditioning in patients treated with primary percutaneous coronary intervention, evaluated by magnetic resonance. Circ Cardiovasc Interv. 2010 Feb 1;3(1):34-41. doi: 10.1161/CIRCINTERVENTIONS.109.905521. Epub 2010 Jan 26.

Reference Type DERIVED
PMID: 20118154 (View on PubMed)

Other Identifiers

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KF 01 326257

Identifier Type: -

Identifier Source: org_study_id

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