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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GIANPAOLO NICCOLI, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00590070
First received: December 31, 2007
Last updated: March 25, 2012
Last verified: March 2012
History of Changes
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Rate of major adverse cardiac events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: January 2008
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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)
Active Comparator: 2
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)
Placebo Comparator: 3
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 heparinized saline given in 2 minutes as slow bolus

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590070

Locations
Italy
Dipartimento Medicina Cardiovascolare
Rome, Italy, 00100
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Giampaolo Niccoli, MD, PhD Institute of Cardiology UCSC
Study Chair: Filippo Crea, MD Institute of Cardiology UCSC
  More Information

Publications:
Rezkalla SH., Kloner RA.. No reflow phenomenon . Circulation 2002; 105: 656-662
Burzotta F, Testa L, Giannico F, Biondi ZOccai GG, Trani C, Romagnoli E, Mazzari M, Mongiardo R, Siviglia M, Niccoli G, De Vita M, Porto I, Schiavoni G, Crea F. Adjunctive devices in primary or rescue PCI: A meta-analysis of randomized trias. .Int J.. Cardiol 2007 Mar 23;

Responsible Party: GIANPAOLO NICCOLI, Dott. Prof., Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT00590070     History of Changes
Other Study ID Numbers: REOPEN-AMI 2007-006794-93, 2007-006794-93
Study First Received: December 31, 2007
Last Updated: March 25, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Catholic University of the Sacred Heart:
myocardial infarction
no reflow
primary PCI
Coronary no-reflow phenomenon
primary percutaneous coronary intervention (primary PCI)

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Adenosine
Nitroprusside
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 22, 2013