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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00568061
Other study ID # INOT 44
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date June 2006
Est. completion date June 2008

Study information

Verified date May 2016
Source Mallinckrodt
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


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
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