Nitric Oxide in Myocardial Infarction Size

NCT00568061 | Terminated Phase 2 Results DMC

• 1 other identifier: INOT 44
• Study Type: interventional
• Target: 29
• Locations: 3 countries
• Sites: 14

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.

Conditions

Acute Myocardial Infarction; ST Elevation MI; STEMI

Keywords

INOT44; NOMI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (2)

Inhaled Nitric Oxide

EXPERIMENTAL

Inhaled Nitric oxide administered at 80 parts per million (ppm)

Drug: Nitric Oxide

Placebo

PLACEBO COMPARATOR

Inhaled nitrogen gas (Placebo) administered at 80 ppm

Drug: Placebo

Interventions

Nitric Oxide DRUG

Nitric oxide for inhalation

Also known as: INOmax®

Inhaled Nitric Oxide

Placebo DRUG

Nitrogen gas (placebo) for inhalation

Also known as: Nitrogen gas

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (14)

Providence Hospital

Mobile, Alabama, 36608, United States

Location

Baptist Cardiac & Vascula Institute

Miami, Florida, 33176, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Jack D. Weiler Hospital

The Bronx, New York, 10467, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

LeBauer Cardiology

Greensboro, North Carolina, 27401, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC Cardiovascular Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Central Utah Imaging

Provo, Utah, 84604, United States

Location

Virga Jesse Hospital

Hasselt, 3500, Belgium

Location

University of Alberta Hospital

Edmonton, Alberta, TGG 2B7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Nitric Oxide; Endothelium-Dependent Relaxing Factors; Nitrogen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals; Vasodilator Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Elements; Gases

Limitations and Caveats

The validated summary tables and CSR are not available for this legacy registration that was transferred to us eight years after it was terminated for low enrollment, so posting of results for secondary outcome measures is not possible.

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt Pharmaceuticals

clinicaltrials@mnk.com

800-556-3314

Study Officials

• James Baldassarre, MD

  Mallinckrodt

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 5, 2007
• Study Start: June 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: November 21, 2019
• Results First Posted: August 27, 2010

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); CA (2); US (11)