Salvage: Postconditioning With Adenosine for STEMI

NCT ID: NCT00284323

Last Updated: 2006-01-31

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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Investigate the effect of selective intracoronary administration of adenosine on myocardial salvage and microvascular integrity in the setting of acute myocardial infarction.

Detailed Description

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Prospective, single center, randomized clinical study. Study design is random patient assignment to selective intracoronary administration of adenosine or control immediately before restoration of coronary artery patency in patients presenting with an acute ST segment-elevation myocardial infarction (STEMI). Randomisation will be stratified for the duration of symptoms (\< 4 hours vs \> 4 hours).

Conditions

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Acute ST Elevation Myocardial Infarction

Keywords

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Acute Myocardial Infarction PCI Adenosine Postconditioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Adenosine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Myocardial infarction of less than 12 hours duration with symptoms lasting at least 20 minutes.
* ECG-criteria: ST-segment elevation of \> 0.1 mV in 2 or more limb leads or \> 0.2 mV in 2 or more contiguous precordial leads or presumed new left bundle branch block.
* Written informed consent prior to inclusion in the study. If this is not possible, verbal informed consent from the patient or written assent of a legally acceptable representative should be obtained, to be followed by written informed consent by the patient at the earliest subsequent opportunity.
* Adequate vascular access seems possible (femoral pulsation palpable).

Exclusion Criteria

* Contra-indication to heparin, LMWH, clopidogrel.
* Anticipated difficulty with vascular access.
* Cardiogenic shock.
* Inability to give informed consent (or assent).
* High grade atrioventricular block; severe asthma; treatment with theophylline, glibenclamide (Diamicron) or dipyridamole.
* Prior CABG.
* Participation in an investigational drug or device study within the past 30 days.
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gasthuisberg

OTHER

Sponsor Role lead

Principal Investigators

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Walter JR Desmet, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen Leuven, Dept. of Cardiology

Locations

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Universitaire Ziekenhuizen Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Walter JR Desmet, Ph.D.

Role: CONTACT

Phone: +3216332211

Email: [email protected]

Facility Contacts

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Walter JR Desmet, Ph.D.

Role: primary

References

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Desmet W, Bogaert J, Dubois C, Sinnaeve P, Adriaenssens T, Pappas C, Ganame J, Dymarkowski S, Janssens S, Belmans A, Van de Werf F. High-dose intracoronary adenosine for myocardial salvage in patients with acute ST-segment elevation myocardial infarction. Eur Heart J. 2011 Apr;32(7):867-77. doi: 10.1093/eurheartj/ehq492. Epub 2010 Dec 31.

Reference Type DERIVED
PMID: 21196444 (View on PubMed)

Other Identifiers

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WD Salvage ML3181

Identifier Type: -

Identifier Source: org_study_id