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Nitric Oxide in Myocardial Infarction Size (NOMI)

Primary Purpose

Acute Myocardial Infarction, ST Elevation MI, STEMI

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nitric Oxide
Placebo
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring INOT44, NOMI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Providence Hospital
  • Baptist Cardiac & Vascula Institute
  • Northwestern University
  • University of Kansas Hospital
  • Massachusetts General Hospital
  • Jack D. Weiler Hospital
  • Montefiore Medical Center
  • LeBauer Cardiology
  • Allegheny General Hospital
  • UPMC Cardiovascular Institute
  • Central Utah Imaging
  • Virga Jesse Hospital
  • University of Alberta Hospital
  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inhaled Nitric Oxide

Placebo

Arm Description

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

Inhaled nitrogen gas (Placebo) administered at 80 ppm

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Myocardial Infarction (MI) Size at 48-72 Hours
MI Size Normalized to Area at Risk
Myocardial Perfusion at Coronary Angiography
Infarct Transmurality
Global & Regional Left Ventricular (LV) Function and LV Mass
Change in Global LV Function and Mass
MI Size as a Fraction of LV Size
Resolution of ST Segment Elevation Compared With That Observed at Enrollment
Troponin T Levels and CPK-MB Area Under the Curve
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

Full Information

First Posted
December 3, 2007
Last Updated
November 20, 2019
Sponsor
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT00568061
Brief Title
Nitric Oxide in Myocardial Infarction Size
Acronym
NOMI
Official Title
The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow Enrollment
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, ST Elevation MI, STEMI
Keywords
INOT44, NOMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled Nitric Oxide
Arm Type
Experimental
Arm Description
Inhaled Nitric oxide administered at 80 parts per million (ppm)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inhaled nitrogen gas (Placebo) administered at 80 ppm
Intervention Type
Drug
Intervention Name(s)
Nitric Oxide
Other Intervention Name(s)
INOmax®
Intervention Description
Nitric oxide for inhalation
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Nitrogen gas
Intervention Description
Nitrogen gas (placebo) for inhalation
Primary Outcome Measure Information:
Title
Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size
Description
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).
Time Frame
48-72 hours
Secondary Outcome Measure Information:
Title
Myocardial Infarction (MI) Size at 48-72 Hours
Time Frame
48-72 hours
Title
MI Size Normalized to Area at Risk
Time Frame
48-72 hours
Title
Myocardial Perfusion at Coronary Angiography
Time Frame
at completion of primary coronary intervention (PCI)
Title
Infarct Transmurality
Time Frame
48-72 hours and 4 months
Title
Global & Regional Left Ventricular (LV) Function and LV Mass
Time Frame
48-72 hours and 4 months
Title
Change in Global LV Function and Mass
Time Frame
between 48-72 hours and 4 months
Title
MI Size as a Fraction of LV Size
Time Frame
4 months
Title
Resolution of ST Segment Elevation Compared With That Observed at Enrollment
Time Frame
4 hours
Title
Troponin T Levels and CPK-MB Area Under the Curve
Time Frame
48 hours
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Baldassarre, MD
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Providence Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Baptist Cardiac & Vascula Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Jack D. Weiler Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
LeBauer Cardiology
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
UPMC Cardiovascular Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Central Utah Imaging
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Virga Jesse Hospital
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
TGG 2B7
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Nitric Oxide in Myocardial Infarction Size

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