Nitric Oxide in Myocardial Infarction Size (NOMI)

This study has been terminated.

(Slow Enrollment)

Sponsor:

Information provided by:

INO Therapeutics

ClinicalTrials.gov Identifier:

NCT00568061

First received: December 3, 2007

Last updated: June 27, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 3, 2007

Last Updated Date

June 27, 2011

Start Date ^ICMJE

June 2006

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]

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).

Original Primary Outcome Measures ^ICMJE

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 [ Time Frame: 48-72 hours ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00568061 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

MI Size at 48-72 Hours [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
MI Size Normalized to Area at Risk [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
Myocardial Perfusion at Coronary Angiography [ Time Frame: at completion of PCI ] [ Designated as safety issue: No ]
Infarct Transmurality [ Time Frame: 48-72 hours and 4 months ] [ Designated as safety issue: No ]
Global & Regional LV Function and LV Mass [ Time Frame: 48-72 hours and 4 months ] [ Designated as safety issue: No ]
Change in Global LV Function and Mass [ Time Frame: between 48-72 hours and 4 months ] [ Designated as safety issue: No ]
MI Size as a Fraction of LV Size [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Resolution of ST Segment Elevation Compared With That Observed at Enrollment [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Troponin T Levels and CPK-MB Area Under the Curve [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
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 [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

MI size at 48-72 hours, size normalized to area at risk at 48-72 hours, myocardial perfusion at coronary angiography at the completion of PCI, Infarct transmurality, Myocardial perfusion at 48-72 hours and 4 months, Global & regional left LV function [ Time Frame: 48-72 hours and 4 months ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Nitric Oxide in Myocardial Infarction Size

Official Title ^ICMJE

The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Acute Myocardial Infarction
ST Elevation MI
STEMI

Intervention ^ICMJE

Drug: nitric oxide for inhalation

MI size at 48-72 hours

Other Name: INOmax®

Study Arm (s)

Active Comparator: NO

Intervention: Drug: nitric oxide for inhalation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 TIMI 0 or 1 coronary flow with resulting TIMI 2 or 3 flow
Greater than 18 years of age
Signed IRB approved informed consent

Exclusion Criteria:

Prior myocardial infarction
Requirement for urgent cardiac surgery
Previous CABG or 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 60ml/min/1.73m² 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Canada

Administrative Information

NCT Number ^ICMJE

NCT00568061

Other Study ID Numbers ^ICMJE

INOT 44

Has Data Monitoring Committee

Yes

Responsible Party

Rob Small, INO Therapeutics

Study Sponsor ^ICMJE

INO Therapeutics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

James Baldassarre, MD

INO Therapeutics

Information Provided By

INO Therapeutics

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top