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

David Garcia-Dorado

Status and phase

Completed

Phase 3

Conditions

Acute Myocardial Infarction

Treatments

Drug: Adenosine

Study type

Interventional

Funder types

Other

Identifiers

NCT00781404

2007-006671-36 (EudraCT Number)

HUValldHebronRI

Details and patient eligibility

About

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.

Full 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.

Enrollment

201 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.