Effects of Nitric Oxide for Inhalation in Myocardial Infarction Size (NOMI)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to determine the effects of Nitric Oxide for Inhalation on Myocardial Infarction Size.

Condition or disease	Intervention/treatment	Phase
Acute Myocardial Infarction	Drug: Nitric Oxide; Drug: MI size at 48-72 hours	Phase 2

Detailed Description:

The primary objective of the trial is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size as a fraction of left ventricular size at 48-72 hours in patients presenting with an ST segment elevation MI who undergo successful percutaneous coronary intervention.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	250 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size
Study Start Date :	October 2010
Actual Primary Completion Date :	May 2014
Actual Study Completion Date :	May 2014

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Nitric Oxide; nitric oxide for inhalation	Drug: Nitric Oxide; MI size at 48-72 hours; Other Name: vasoKINOX 450
Placebo Comparator: Placebo; inhalation gas	Drug: MI size at 48-72 hours; Placebo gas

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Myocardial infarction size as a fraction of left ventricular size [ Time Frame: 48-72 hours ]
   Myocardial infarction size as a fraction of left ventricular size at 48-72 hours in patients presenting with an ST segment elevation MI who undergo successful percutaneous coronary intervention.

Secondary Outcome Measures :

1. MI size, extent and transmurality of microvascular obstruction [ Time Frame: 48-72 hours ]
   MI size, extent and transmurality of microvascular obstruction measured by MRI
2. MI size normalized to area at risk [ Time Frame: 48-72 hours ]
3. Myocardial perfusion at coronary angiography at the completion of PCI (corrected TIMI frame count and myocardial blush grade). [ Time Frame: at completion of PCI, as expected 1 day ]
4. Transmurality of infarct (as average percent wall thickness in all segments showing delayed enhancement). [ Time Frame: at 48 - 72 hours and 4 months ]
5. Myocardial perfusion(MRI). [ Time Frame: at 48-72 hours and 4 months ]
6. Global and regional left ventricular function and left ventricular mass at 48 - 72hours and 4 months after MI and the change in global LV function and mass between 48-72 hours and 4 months. MI size as a fraction of LV size at 4 months after MI. [ Time Frame: 48-72 hours and 4 months ]
7. Resolution of ST segment elevation (serial ECGs) as indicated by the decrease in the total ST elevation (in mV) at 4 hours compared with that observed at enrollment. [ Time Frame: at 4 hours ]
8. Troponin T levels and CPK-MB area under the curve at 48 hours. [ Time Frame: 48 hours ]
9. Change in adverse remodeling parameters (compared with 48-72 hours):changes in LV end-diastolic volume, end-systolic volume, end-diastolic myocardial wall thickness in infarct, peri-infarct and remote areas and in sphericity index. [ Time Frame: 4 months ]
   Change in adverse remodeling parameters (compared with 48-72 hours):changes in LV end-diastolic volume, end-systolic volume, end-diastolic myocardial wall thickness in infarct, peri-infarct and remote areas and in sphericity index at end-diastole and end-systole.
10. Death, nonfatal recurrent MI, recurrent ischemia necessitating re-hospitalization, PCI, or surgical revascularization, and stroke (i.e. combined CV endpoint) at 4 months. Enzyme leak during subsequent scheduled PCI will not be considered new ischemia/MI. [ Time Frame: 4 months ]
11. Assess the safety of inhaled NO for this use as determined by reported adverse events (including bleeding and laboratory changes). [ Time Frame: during treatment gas period, an average of 6 hours ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Acute myocardial infarction (defined as an episode of chest pain or related symptom lasting greater than 2 hours but less than 12 hours and electrocardiographic evidence of ST elevation (measured as 0.08 seconds after the J point; sum greater or equal to 0.6 mV in leads I, II, III, AVL, AVF, V1-V6).
2. No evidence of congestive heart failure (no S3 or evidence of pulmonary edema) and normal oxygen saturation on ≤ 2L oxygen by NC.
3. All patients must undergo successful percutaneous coronary intervention for TIMI 0 or 1 coronary flow with resulting TIMI 2 or 3 (residual stenosis less than 30% if stented and less than 50% if opened by balloon angioplasty).
4. Age > 18 years.
5. Signed EC approved informed consent.

Exclusion Criteria:

1. Prior myocardial infarction (as determined by patient history and/or ECG), cardiac surgery, or severe pericardial, congenital, cardiomyopathic or valvular heart disease.
2. Requirement for urgent cardiac surgery.
3. Previous CABG or PCI.
4. Left bundle branch block.
5. Unable to tolerate magnetic resonance imaging (including disallowed metallic implants or BMI > 35) or unable to tolerate gadolinium contrast media, including patients with calculated creatinine clearance less than 60 ml/min/1.73 m2 BSA.
6. 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 to presentation.
7. Known or suspected aortic dissection.
8. Prior history of pulmonary disease requiring chronic oxygen therapy.
9. Pregnancy, lactating and woman of childbearing potential.
10. Use of investigational drugs or device within the 30 days prior to enrollment to the study. Investigational uses of approved therapies will be allowed.
11. Medical problem likely to preclude completion of the study.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Belgium
Jessa Hospital
Hasselt, Belgium
UZ Leuven
Leuven, Belgium, 3000
Hungary
Semmelweis University Heart Center
Budapest, Hungary, 1122
Poland
John Paul II Hospital
Krakow, Poland, 31-202

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

Principal Investigator:	Stefan Janssens, Prof Dr	UZ Leuven
Principal Investigator:	Frans Van de Werf, Prof Dr	UZ Leuven

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

NOMI: Final Statistical Analysis Plan 19 May 2014 

Responsible Party:	Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:	NCT01398384 History of Changes
Other Study ID Numbers:	LCC2010.01
First Posted:	July 20, 2011
Last Update Posted:	May 21, 2014
Last Verified:	May 2014

Keywords provided by Universitaire Ziekenhuizen Leuven:

ST Elevation MI; STEMI

Additional relevant MeSH terms:

Infarction; Myocardial Infarction; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nitric Oxide; Bronchodilator Agents; Autonomic Agents	Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Free Radical Scavengers; Antioxidants; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Endothelium-Dependent Relaxing Factors; Vasodilator Agents; Gasotransmitters; Protective Agents