Status:
COMPLETED
Randomized Placebo-controlled Trial of Inhaled iNO in Acute ST-segment Elevation MI Treated by Primary Angioplasty
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
STEMI
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Reperfusion of ischemic myocardium, termed ischemia/reperfusion during the treatment of MI may result in paradoxical myocardial injury compromising myocardial salvage and left ventricular functional r...
Detailed Description
Eligible consenting patients will be randomly assigned to either of the 2 treatment arms using a computer-generated randomization sequence. Treatment arms: 1) Intervention group, treated with inhalati...
Eligibility Criteria
Inclusion
- Subject is over 18 years old
- Subject has an acute ST segment elevation myocardial infarction defined as the presence of ST segment elevation in at least two contiguous leads or new left bundle branch block and the presence of symptoms at rest typical of myocardial ischemia for at least 30 minutes but less than 12 hours prior to admission
- Subject is eligible for primary PCI
- Subject understands the nature of the procedure and provides written informed consent prior to the catheterization procedure
- Subject is willing to comply with pre specified follow up evaluation and can be contacted by telephone
- Subject is male or a non pregnant female
- Subject is a candidate for urgent PCIintervention for reperfusion of an infarct related artery that is totally occluded and is more than 2.5mm in diameter.
Exclusion
- Subject is currently enrolled in another investigational study of a new drug, biologic or device at the time of study screening
- Ischemic symptom onset more than 12 hours prior to presentation
- Subject with a history of a previous Q wave myocardial infarction
- A PCI procedure of any kind within 30 days prior to the procedure.
- Subject with previously known impaired left ventricular function from any reason
- Subject with STEMI that requires treatment of the left main coronary artery during the primary PCI.
- Patients who are hemodynamically unstable (Killip class 3 or 4, mechanical ventilation, life threatening ventricular arrhythmias, patients resuscitated from cardiac arrest)
- Co-morbid condition that could limit the subject's ability to participate in the trial or to comply with follow-up requirements
- Concurrent medical condition with a life expectancy of less than 12 months.
- Documented left ventricular ejection fraction less than 45% prior to the index event
- History of cerebrovascular accident or transient ischemic attack in the last 6 months
- Known severe renal failure (serum creatinine level more than2.5 mg/dl
- History of bleeding diathesis or coagulopathy or inability or unwillingness to receive blood transfusions.
- Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel and ticlopidine, cobalt, nickel, L 605 Cobalt chromium alloy, or sensitivity to contrast media, which cannot be adequately pre-medicated
- Bleeding diathesis.
- Evidence of active gastrointestinal bleeding or a history of such bleeding that is not known to have been treated and proven to have resolved
- History of hepatitis (viral, ischemic or chemically induced), clinical jaundice, history of cirrhosis
- Subject is deemed in definite need of CABG surgery during the index hospitalization
- Recent (less than 72 hours) use of sildenafil (Viagra, Revatio), verdenafil (Lefvitra), or tadalfil (Cialis)
- Angiographic exclusion criteria:
- The infarct vessel is a surgical bypass graft, clinically significant left main coronary artery disease (obstruction greater than 50 percent in the left main coronary artery) in the absence of patent bypass grafts to the left anterior descending and left circumflex arteries;
- Target lesion is located in an aorto-ostial position or within 2 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX)
- target lesion(s) with severe calcification.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00854711
Start Date
August 1 2009
End Date
August 1 2012
Last Update
July 7 2016
Active Locations (1)
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1
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel