Myocardial Protection With Adenosine During Primary Percutaneous Coronary Intervention in Pts With STEMI (PROMISE)
|ClinicalTrials.gov Identifier: NCT00781404|
Recruitment Status : Completed
First Posted : October 29, 2008
Last Update Posted : February 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Drug: Adenosine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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.|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||July 2012|
- Infarct size measured by MRI [ Time Frame: between 5 and 10 days after acute myocardial infarction ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781404
|Barcelona, Spain, 08035|
|Principal Investigator:||David García-Dorado, MD, PhD||Valle Hebron Hospital|