Overview

THE REOPEN-AMI STUDY - Intracoronary Nitroprusside Versus Adenosine in Acute Myocardial Infarction

Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
0
Participant gender:
All
Summary
The occurrence of no-reflow phenomenon after recanalization of the infarct related artery in acute myocardial infarction is described in up to 40% of cases. This event is associated with a worse prognosis at follow up and an unfavourable left ventricular remodelling . Two main pathogenetic mechanisms cause no-reflow: distal embolization and ischemia-reperfusion injury. Due to the multifactorial pathogenesis of no-reflow during acute MI a combined mechanic and pharmacologic approach is believed to offer a better solution for achieving optimal microvascular reperfusion. Thus, in this randomized study we will assess the effect of nitroprusside or adenosine in adjunct to current best therapy (thrombus aspiration and IIb-IIIa antagonists) for ST elevation MI using ST segment resolution on standard 12 leads ECG as primary endpoint of myocardial reperfusion.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Catholic University of the Sacred Heart
Treatments:
Adenosine
Nitroprusside
Criteria
Inclusion Criteria:

1. Symptoms onset < 12 hours prior to enrollment

2. ST-segment elevation of at least 2 mm in two or more contiguous leads

3. TIMI flow 0-1 at baseline angiography

Exclusion Criteria:

Demographic, history and clinical examination

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
medications, 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