Randomized Evaluation of Intracoronary nitroprusside vs adenosine after thrombus aspiration during primary PErcutaneous coronary intervention for the prevention of No reflow in Acute Myocardial Infarction: REOPEN -AMI study - REOPEN -AMI

Conditions: Acute myocardial infarction with ST segment elevation
MedDRA version: 6.1Level: PTClassification code 10000891

Registration Number: EUCTR2007-006794-93-IT

Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Symptoms onset < 12 hours prior to enrollement 2. ST-segment elevation of at least 2 mm in two or more contiguous leads 3. TIMI flow 0-1 at baseline angiography
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. age less than 18 years 2. previous STEMI 3. patients presenting in cardiogenic shock 4. pregnancy 5. patients with renal failure 6. contraindications to contrast agents, which cannot be managed medically or study mediactions, including aspirin, clopidogrel and ticlopidine, and heparin Electrocardiogram 7. left bundle branch block, paced rhythm, frequent ventricular ectopy, pre-excitation or other conditions or artifacts interfering with interpretation of ST segment resolution Angiography 8. culprit lesion located in a by-pass graft 9. stent thrombosis 10. culprit lesion non identified 11. left main disease

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Aim of this randomized study is to assess the effect of nitroprusside or adenosine in adjunct to current best therapy (thrombus aspiration and IIb-IIIa antagonists) for ST elevation MI;Secondary Objective: 1) rate of angiographic no-reflow; 2) changes of LV volumes at follow-up; 3) rate of no-reflow on IC ECG; 4) rate of no-reflow at echocontrastography; 5) rate of MACEs;Primary end point(s): Primary end-point of the study will be rate of ST resolution on surface ECG.

Secondary Outcome Measures