Nitric Oxide in Myocardial Infarction Size

Acute Myocardial Infarction Clinical Trial

— NOMI  

Official title:

The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00568061
• Other study ID #: INOT 44
• Status: Terminated
• Phase: Phase 2
• Start date: June 2006
• Est. completion date: June 2008

Study information

• Verified date: May 2016
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• ST Elevation MI
• STEMI

Intervention

Drug:
• Nitric Oxide
Nitric oxide for inhalation
• Placebo
Nitrogen gas (placebo) for inhalation

Locations

Country	Name	City	State
Belgium	Virga Jesse Hospital	Hasselt
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	St. Michael's Hospital	Toronto	Ontario
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Jack D. Weiler Hospital	Bronx	New York
United States	Montefiore Medical Center	Bronx	New York
United States	Northwestern University	Chicago	Illinois
United States	LeBauer Cardiology	Greensboro	North Carolina
United States	University of Kansas Hospital	Kansas City	Kansas
United States	Baptist Cardiac & Vascula Institute	Miami	Florida
United States	Providence Hospital	Mobile	Alabama
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UPMC Cardiovascular Institute	Pittsburgh	Pennsylvania
United States	Central Utah Imaging	Provo	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Countries where clinical trial is conducted

United States,  Belgium,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size	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).	48-72 hours
Secondary	Myocardial Infarction (MI) Size at 48-72 Hours		48-72 hours
Secondary	MI Size Normalized to Area at Risk		48-72 hours
Secondary	Myocardial Perfusion at Coronary Angiography		at completion of primary coronary intervention (PCI)
Secondary	Infarct Transmurality		48-72 hours and 4 months
Secondary	Global & Regional Left Ventricular (LV) Function and LV Mass		48-72 hours and 4 months
Secondary	Change in Global LV Function and Mass		between 48-72 hours and 4 months
Secondary	MI Size as a Fraction of LV Size		4 months
Secondary	Resolution of ST Segment Elevation Compared With That Observed at Enrollment		4 hours
Secondary	Troponin T Levels and CPK-MB Area Under the Curve		48 hours
Secondary	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