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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00781404

Acronym

PROMISE

Enrollment

201

Registered

2008-10-29

Start date

2008-10-31

Completion date

2012-07-31

Last updated

2013-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

adenosine, angioplasty, acute myocardial infarction, acute coronary syndrome with ST segment elevation, infarct size, rescued myocardium

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.

Interventions

DRUGAdenosine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Infarct size measured by MRI	between 5 and 10 days after acute myocardial infarction

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026