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| Sponsored by: |
Catholic University of the Sacred Heart |
|---|---|
| Information provided by: | Catholic University of the Sacred Heart |
| ClinicalTrials.gov Identifier: | NCT00590070 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction |
Drug: adenosine Drug: nitroprusside Drug: placebo |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 240 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Patients will receive intravenous administration of abciximab prior to PCI. After wire crossing, thrombus aspiration will be performed. The device will removed outside the body, flushed with saline and subsequently reintroduced in the culprit vessel beyond the occlusion site and intracoronary drugs will be selectively administered.
|
Drug: adenosine
Adenosine (80 mcg as fast bolus followed by 2 mg given in 33cc of saline in 2 minutes as slow bolus)
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2: Active Comparator
Patients will receive intravenous administration of abciximab prior to PCI. After wire crossing, thrombus aspiration will be performed. The device will removed outside the body, flushed with saline and subsequently reintroduced in the culprit vessel beyond the occlusion site and intracoronary drugs will be selectively administered.
|
Drug: nitroprusside
Nitroprusside (60 mcg as fast bolus followed by 100 mcg given in 33cc of 5% glucose in 2 minutes as slow bolus)
|
|
3: Placebo Comparator
Patients will receive intravenous administration of abciximab prior to PCI. After wire crossing, thrombus aspiration will be performed. The device will removed outside the body, flushed with saline and subsequently reintroduced in the culprit vessel beyond the occlusion site and intracoronary drugs will be selectively administered
|
Drug: placebo
33 cc of heparinzed saline given in 2 minutes as slow bolus
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Demographic, history and clinical examination
contraindications to contrast agents, which cannot be managed medically or study mediactions, including aspirin, clopidogrel and ticlopidine, and heparin
Electrocardiogram
Contacts and Locations| Contact: Giampaolo Niccoli, MD, PhD | 00390630151 ext 4187 | gniccoli73@hotmail.it |
| Contact: Domenico D'Amario, MD | 00390630151 ext 4187 | domenico.damario@gmail.com |
| Italy | |
| Istituto di Cardiologia | |
| Rome, Italy, 00100 | |
| Principal Investigator: | Giampaolo Niccoli, MD, PhD | Institute of Cardiology UCSC |
| Study Chair: | Filippo Crea, MD | Institute of Cardiology UCSC |
More Information
| Responsible Party: | Universita' Cattolica del sacro Cuore ( Giampaolo Niccoli/MD, PhD ) |
| Study ID Numbers: | REOPEN-AMI 2007-006794-93, 2007-006794-93 |
| Study First Received: | December 31, 2007 |
| Last Updated: | January 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00590070 History of Changes |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
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myocardial infarction no reflow primary PCI Coronary no-reflow phenomenon primary percutaneous coronary intervention (primary PCI) |
|
Vasodilator Agents Heart Diseases Myocardial Ischemia Vascular Diseases Cardiovascular Agents Ischemia Antihypertensive Agents Thrombosis Nitric Oxide Donors |
Nitric Oxide Necrosis Nitroprusside Analgesics Peripheral Nervous System Agents Anti-Arrhythmia Agents Infarction Myocardial Infarction Adenosine |
|
Vasodilator Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Physiological Effects of Drugs Vascular Diseases Cardiovascular Agents Ischemia Antihypertensive Agents Pharmacologic Actions Nitric Oxide Donors Necrosis |
Pathologic Processes Sensory System Agents Therapeutic Uses Nitroprusside Cardiovascular Diseases Anti-Arrhythmia Agents Peripheral Nervous System Agents Analgesics Infarction Central Nervous System Agents Myocardial Infarction Adenosine |
