Nitric Oxide in Myocardial Infarction Size - Full Text View

Sponsor:	INO Therapeutics
Information provided by:	INO Therapeutics
ClinicalTrials.gov Identifier:	NCT00568061

Purpose

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 who undergo successful percutaneous coronary intervention.

Condition	Intervention	Phase
Acute Myocardial Infarction ST Elevation MI STEMI	Drug: nitric oxide for inhalation	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

Drug Information available for: Nitric oxide

U.S. FDA Resources

Further study details as provided by INO Therapeutics:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	29
Study Start Date:	June 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
NO: Active Comparator	Drug: nitric oxide for inhalation MI size at 48-72 hours

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568061

Locations

United States, Alabama
Providence Hospital
Mobile, Alabama, United States, 36608
United States, Florida
Baptist Cardiac & Vascula Institute
Miami, Florida, United States, 33176
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Kansas
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Jack D. Weiler Hospital
Bronx, New York, United States, 10467
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, North Carolina
LeBauer Cardiology
Greensboro, North Carolina, United States, 27401
United States, Pennsylvania
UPMC Cardiovascular Institute
Pittsburgh, Pennsylvania, United States, 15213
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Utah
Central Utah Imaging
Provo, Utah, United States, 84604
Belgium
Virga Jesse Hospital
Hasselt, Belgium, 3500
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, TGG 2B7
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8

Sponsors and Collaborators

INO Therapeutics

Investigators

Study Director:

James Baldassarre, MD

INO Therapeutics

More Information

No publications provided

Responsible Party:	INO Therapeutics ( Rob Small )
Study ID Numbers:	INOT 44
Study First Received:	December 3, 2007
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00568061 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by INO Therapeutics:

INOT44
NOMI

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Vasodilator Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Physiological Effects of Drugs
Necrosis
Pathologic Processes
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Cardiovascular Diseases

Myocardial Infarction
Heart Diseases
Vascular Diseases
Anti-Asthmatic Agents
Ischemia
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Nitric Oxide
Autonomic Agents
Peripheral Nervous System Agents
Infarction
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 30, 2009