Myocardial Protection With Adenosine During Primary Percutaneous Coronary Intervention in Pts With STEMI (PROMISE)
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|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|
- Drug: Adenosine
Single dose of adenosine. Solution for infusion of 0.45 mg/mL. Enteral use.Other Name: Adenocor
- Infarct size measured by MRI [ Time Frame: between 5 and 10 days after acute myocardial infarction ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|