Nitric Oxide in Myocardial Infarction Size

Phase 2

Terminated

• Conditions: STEMI; Acute Myocardial Infarction; ST Elevation MI
• Interventions: Drug: Placebo; Drug: Nitric Oxide

• Registration Number: NCT00568061
• Lead Sponsor: Mallinckrodt

Brief Summary

The purpose of this study is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size at 48-72 hours in patients presenting with an ST segment elevation MI (STEMI) who undergo successful percutaneous coronary intervention.

Detailed Description

The purpose of the trial is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size as a fraction of left ventricular (LV) size at 48-72 hours in patients presenting with an ST segment elevation MI who undergo successful percutaneous coronary intervention (PCI).

The primary endpoint for this study will be myocardial infarction size as a fraction of left ventricular size at 48-72 hours as measured by contrast-enhanced cardiac MRI.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-05
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2010-08-03
• Results First Submitted QC: 2010-08-03
• Results First Posted: 2010-08-27
• Status Verified: 2016-05
• Last Update Submitted: 2019-11-20
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Acute myocardial infarction and electrocardiographic evidence of ST elevation
• No clinical evidence of congestive heart failure
• All patients must undergo successful percutaneous coronary intervention for thrombolysis in myocardial infarction (TIMI) 0 or 1 coronary flow with resulting TIMI 2 or 3 flow
• Greater than 18 years of age
• Signed Institutional Review Board (IRB) approved informed consent

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Exclusion Criteria

• Prior myocardial infarction
• Requirement for urgent cardiac surgery
• Previous coronary artery bypass graft (CABG) or primary coronary intervention (PCI)
• Left bundle branch block
• Heart block that is expected to require a temporary pacemaker for greater than 72 hours
• Prior use of thrombolytic therapy for the current event
• Unable to tolerate magnetic resonance imaging or unable to tolerate gadolinium contrast media, including patients with a calculated creatinine clearance less than 60 ml/min/1.73m² Body Surface Area (BSA)
• Active or recent hemorrhage requiring an invasive procedure for evaluation or transfusion within 6 weeks prior to presentation, or hemorrhagic stroke within the 6 weeks prior
• Neutropenia (WBC <2000 (mm)³), Anemia (HCT <30%, Thrombocytopenia (Thrombocytes <50,000 (mm)³). It is not necessary to confirm blood counts prior to start of study drug in the absence of clinical suspicion.
• Known or suspected aortic dissection.
• Prior history of pulmonary disease requiring chronic oxygen therapy.
• Pregnancy, lactating, and women of childbearing potential.
• Medical problem likely to preclude completion of the study.
• Use of investigational drugs or device within the 30 days prior to enrollment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Inhaled nitrogen gas (Placebo) administered at 80 ppm
Inhaled Nitric Oxide	Nitric Oxide	Inhaled Nitric oxide administered at 80 parts per million (ppm)

Primary Outcome Measures

Name	Time	Method
Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size	48-72 hours	The primary endpoint - mean percent of the myocardial infarction size to the fraction of left ventricular size at 48-72 hours was measured by contrast-enhanced cardiac Magnetic Resonance Imaging (MRI).

Secondary Outcome Measures

Name	Time	Method
Myocardial Infarction (MI) Size at 48-72 Hours	48-72 hours
MI Size Normalized to Area at Risk	48-72 hours
Myocardial Perfusion at Coronary Angiography	at completion of primary coronary intervention (PCI)
Infarct Transmurality	48-72 hours and 4 months
Global & Regional Left Ventricular (LV) Function and LV Mass	48-72 hours and 4 months
Change in Global LV Function and Mass	between 48-72 hours and 4 months
MI Size as a Fraction of LV Size	4 months
Resolution of ST Segment Elevation Compared With That Observed at Enrollment	4 hours
Troponin T Levels and CPK-MB Area Under the Curve	48 hours
Change in Adverse Remodeling Parameters Compared With 48-72 Hrs: Changes in LV End-diastolic Vol, End-systolic Vol, End-diastolic Myocardial Wall Thickness in Infarct, Peri-infarct and Remote Areas, and in Sphericity Index at End-diastole and End-systole	4 months

Trial Locations

Locations (14)

Virga Jesse Hospital; 🇧🇪 Hasselt, Belgium

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Cardiovascular Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States

Baptist Cardiac & Vascula Institute; 🇺🇸 Miami, Florida, United States

Providence Hospital; 🇺🇸 Mobile, Alabama, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Jack D. Weiler Hospital; 🇺🇸 Bronx, New York, United States

LeBauer Cardiology; 🇺🇸 Greensboro, North Carolina, United States

Central Utah Imaging; 🇺🇸 Provo, Utah, United States

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

University of Kansas Hospital; 🇺🇸 Kansas City, Kansas, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States