Effects of Nitric Oxide for Inhalation in Myocardial Infarction Size

Acute Myocardial Infarction Clinical Trial

— NOMI  

Official title:

The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398384
• Other study ID #: LCC2010.01
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2011
• Last updated: May 20, 2014
• Start date: October 2010
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsHungary: National Institute of PharmacyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Nitric Oxide
MI size at 48-72 hours
• MI size at 48-72 hours
Placebo gas

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt
Belgium	UZ Leuven	Leuven
Hungary	Semmelweis University Heart Center	Budapest
Poland	John Paul II Hospital	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Countries where clinical trial is conducted

Belgium,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial infarction size as a fraction of left ventricular size	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.	48-72 hours	No
Secondary	MI size, extent and transmurality of microvascular obstruction	MI size, extent and transmurality of microvascular obstruction measured by MRI	48-72 hours	No
Secondary	MI size normalized to area at risk		48-72 hours	No
Secondary	Myocardial perfusion at coronary angiography at the completion of PCI (corrected TIMI frame count and myocardial blush grade).		at completion of PCI, as expected 1 day	No
Secondary	Transmurality of infarct (as average percent wall thickness in all segments showing delayed enhancement).		at 48 - 72 hours and 4 months	No
Secondary	Myocardial perfusion(MRI).		at 48-72 hours and 4 months	No
Secondary	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.		48-72 hours and 4 months	No
Secondary	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.		at 4 hours	No
Secondary	Troponin T levels and CPK-MB area under the curve at 48 hours.		48 hours	No
Secondary	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.	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.	4 months	No
Secondary	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.		4 months	No
Secondary	Assess the safety of inhaled NO for this use as determined by reported adverse events (including bleeding and laboratory changes).		during treatment gas period, an average of 6 hours	Yes

External Links

•   NOMI: Final Statistical Analysis Plan 19 May 2014