Randomized Placebo-Controlled Trial of Inhaled iNO in Acute ST-Segment Elevation MI Treated by Primary Angioplasty (ENAMOR)
Recruitment status was Not yet recruiting
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 recovery. Nitric oxide (NO) modulates many of the processes contributing to ischemia-reperfusion injury (IR)and inhaled NO (iNO) has been shown to decease infarct size in animal models of IR. iNO has been studied in various clinical settings and has shown promise im modulating the detrimental effects of IR. Clinical toxicity potentially associated with the use of iNO was of no apparent concern in these studies. Although controlled trials of iNO therapy in humans with acute MI have not been published, anecdotal experience indicates a beneficial impact of iNO on the hemodynamic course of patients with right ventricular MI. iNO is widely used to treat neonatal hypoxemia and acute pulmonary hypertension. iNO has been studied at this dose in various clinical settings and side effects related to its use at such doses are extremely uncommon. The effect of iNO on IR injury in patients with acute ST-segment elevation MI is unknown. The investigator intend to perform a prospective, randomized, placebo-controlled, clinical trial of iNO in patients with acute MI undergoing primary percutaneous intervention to determine whether this form of therapy can decrease infarct size and improve clinical outcomes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Randomized Placebo-Controlled Trial of Inhaled iNO in Acute ST-Segment Elevation MI Treated by Primary Angioplasty|
- Infarct size assessed by measurements of myocardial biomarkers (creatine kinase [CK], CK MB, troponin I) from blood samples obtained at admission and repeatedly over the next 3 days. [ Time Frame: 3-days post randomization ] [ Designated as safety issue: No ]
- Major Adverse Cardiac Events (MACE), defined as death, myocardial infarction (MI, Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion(s) revascularization (TLR) (repeat PCI or CABG) at 12-months. [ Time Frame: 12-month post randomization ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: nitric oxide
inhaled nitric oxide 80 ppm and oxygen
Procedure: inhaled nitric oxide
Other Name: iNO
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 inhalation of a mixture of NO 80 ppm and oxygen; or, 2) Control group, inhalation oxygen and nitrogen (placebo). In both groups, oxygen will be administered at the minimal FiO2 required to maintain arterial oxygen saturation determined by pulse oxymetry >97%. Inhalation treatment will be given throughout the angioplasty procedure via a reservoir face mask and a dedicated respiratory circuit. Nitric oxide will be delivered using an FDA-approved device marketed in Israel under license by the Ministry of Health. The device is in routine clinical use in intensive care units, neonatal care units, and catheterization laboratories. An NO-level detector will be employed in the catheterization laboratory to monitor the ambient NO exposure of the staff.
Upon arrival in the catheterization laboratory, a 40 ml blood sample will be obtained for a full chemistry panel, lipid levels, complete blood count. Creatine kinase, creatine kinase MB fraction, and troponin I will be measured at baseline and every 4 hours following the angioplasty procedure during the first 24 hours, and then every 6 hours during the second and third days, and as clinically indicated thereafter.Methemoglobin levels will be measured at baseline, every 30 minutes throughout the interventional procedure, at procedure completion, and at 4 hours post procedure.
All patients will undergo diagnostic angiography and interventional procedures as per standard clinical practice. Post procedural pharmacotherapy, sheath removal, and deployment of hemostatic devices will be left to the discretion of the attending physicians.
Following treatment in the catheterization laboratory, medical treatment throughout hospitalization and recommendations for therapy after discharge will be left to the discretion of the attending cardiologists managing patient care on the hospital wards. These cardiologists will be blinded to the patient randomization status.
|Contact: Amir S Halkin, MDemail@example.com|
|Contact: Shmuel Banai, MDfirstname.lastname@example.org|
|Tel Aviv Sourasky Medical Center||Not yet recruiting|
|Tel Aviv, Israel|
|Contact: Amir S Halkin, MD 972-3-6973395 email@example.com|
|Contact: Shmuel Banai 972-3-6973395 firstname.lastname@example.org|
|Principal Investigator: Amir S Halkin, MD|
|Principal Investigator:||Amir S Halkin, MD||TASMC|