Randomized Placebo-controlled Trial of Inhaled iNO in Acute ST-segment Elevation MI Treated by Primary Angioplasty

NCT00854711 | Completed Phase 2 DMC

• 1 other identifier: TASMC-09-AH-7009-CTIL
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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 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.

Conditions

STEMI

Keywords

ST elevated Myocardical infraction

Outcome Measures

Primary Outcomes (1)

• 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.

  3-days post randomization

Secondary Outcomes (1)

• 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.

  12-month post randomization

Study Arms (2)

nitric oxide

EXPERIMENTAL

inhaled nitric oxide 80 ppm and oxygen

Procedure: inhaled nitric oxide

standart of care

PLACEBO COMPARATOR

no intervention

Procedure: inhaled nitric oxide

Interventions

inhaled nitric oxide PROCEDURE

80 PPM

Also known as: iNO

nitric oxide; standart of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Amir S Halkin, MD

  TASMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional cardiologist

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: March 3, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: August 1, 2012
• Last Updated: July 7, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)