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

Acute Myocardial Infarction Clinical Trial

— PROMISE  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781404
• Other study ID #: HUValldHebronRI
• Secondary ID: 2007-006671-36
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2008
• Last updated: February 15, 2013
• Start date: October 2008
• Est. completion date: July 2012

Study information

• Verified date: February 2013
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Adenosine
Single dose of adenosine. Solution for infusion of 0.45 mg/mL. Enteral use.

Locations

Country	Name	City	State
Spain	ValldHebron Hospital	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
David Garcia-Dorado	Hospital Clínico Universitario de Valladolid, Hospital General Universitario Gregorio Marañon, Hospital Universitario Virgen Macarena, Instituto de Ciencias del Corazon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size measured by MRI		between 5 and 10 days after acute myocardial infarction	No