Myocardial Protection With Adenosine During Primary Percutaneous Coronary Intervention in Pts With STEMI (PROMISE)

This study has been completed.

Sponsor:

Collaborators:

Hospital General Universitario Gregorio Marañon

Hospital Clinico Universitario de Valladolid

Hospital Universitario Virgen de la Macarena

Instituto de Ciencias del Corazon

Information provided by (Responsible Party):

David Garcia-Dorado, Hospital Universitari Vall d'Hebron Research Institute

ClinicalTrials.gov Identifier:

NCT00781404

First received: October 28, 2008

Last updated: February 15, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 28, 2008

Last Updated Date

February 15, 2013

Start Date ^ICMJE

October 2008

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Infarct size measured by MRI [ Time Frame: between 5 and 10 days after acute myocardial infarction ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00781404 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Myocardial Protection With Adenosine During Primary Percutaneous Coronary Intervention in Pts With STEMI

Official Title ^ICMJE

Myocardial Protection During reperfusión in Patients With Acute Coronary Syndrome With ST Segment Elevation Submitted to Primary Angioplasty: Effect of Intracoronary Adenosine on Infarct Size and Ventricular Remodeling.

Brief Summary

OBJECTIVE: to evaluate the safety and efficacy of a brief intracoronary infusion of ADO applied at the time of reperfusion to limit infarct size and LV remodelling in patients with ACSST submitted to primary ACTP.

DESIGN: Multicentric, prospective, randomised, parallel, placebo-controlled double-blind study.

PATIENTS: 200 patients older than 18 with ACSST and without prior myocardial infarction receiving primary PTCA within 6 hours after symptom onset.

Detailed Description

The main mechanism responsible for the sanitary impact of ischemic heart disease is cardiomyocyte cell death associated to acute coronary syndrome with ST segment elevation (ACSST). In most of these patients, performing PTCA or thrombolysis as soon as possible does not prevent the occurrence of myocardial necrosis involving a substantial portion of the area at risk. Intracoronary adenosine (ADO) at the time of reperfusion limits infarct size in animals, and preliminary clinical studies indicate that may be also protective in patients with ACSST receiving early reperfusion therapy. OBJECTIVE: to evaluate the safety and efficacy of a brief intracoronary infusion of ADO applied at the time of reperfusion to limit infarct size and LV remodelling in patients with ACSST submitted to primary ACTP. DESIGN: Multicentric, prospective, randomised, parallel, placebo-controlled double-blind study. PATIENTS: 200 patients older than 18 with ACSST and without prior myocardial infarction receiving primary PTCA within 6 hours after symptom onset. PROTOCOL: Intracoronary ADO (4mg) or placebo (saline) infusion distal to the culprit lesion immediately before stent deployment, NMR between 6 and 14 days and after 6 months. END-POINTS: Major: infarct size as measured by NMR, Secondary: changes in LV volumes and EF, and major cardiac events during the follow-up.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Acute Myocardial Infarction

Intervention ^ICMJE

Drug: Adenosine

Single dose of adenosine. Solution for infusion of 0.45 mg/mL. Enteral use.

Other Name: Adenocor

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

201

Completion Date

July 2012

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients older than 18 years.
patients with acute coronary syndrome with ST segment elevation within six hours of the onset of symptoms.

Exclusion Criteria:

patients younger than 18 years and pregnant women.
patients with previous transmural infarction.
patients with clinical evidence of bronchospastic lung disease or prior bronchodilator therapy.
patients with pacemakers.
patients with TIMI flow higher than 1 and lower than 3.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00781404

Other Study ID Numbers ^ICMJE

HUValldHebronRI, 2007-006671-36

Has Data Monitoring Committee

Responsible Party

David Garcia-Dorado, Hospital Universitari Vall d'Hebron Research Institute

Study Sponsor ^ICMJE

David Garcia-Dorado

Collaborators ^ICMJE

Hospital General Universitario Gregorio Marañon
Hospital Clinico Universitario de Valladolid
Hospital Universitario Virgen de la Macarena
Instituto de Ciencias del Corazon

Investigators ^ICMJE

Principal Investigator:

David García-Dorado, MD, PhD

Valle Hebron Hospital

Information Provided By

Hospital Universitari Vall d'Hebron Research Institute

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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