Trial | NCT00781404  Report issue

Title

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.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    adenosine ...

  • Study Participants

    201
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.
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 Started
Oct 31
2008
Primary Completion
May 31
2012
Study Completion
Jul 31
2012
Last Update
Feb 18
2013
Estimate

Drug Adenosine

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

  • Other names: Adenocor

Criteria 

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.
No Results Posted