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

Primary Purpose

Acute Myocardial Infarction

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Nitric Oxide

MI size at 48-72 hours

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring ST Elevation MI, STEMI

Eligibility Criteria

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

Inclusion Criteria:

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).
No evidence of congestive heart failure (no S3 or evidence of pulmonary edema) and normal oxygen saturation on ≤ 2L oxygen by NC.
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).
Age > 18 years.
Signed EC approved informed consent.

Exclusion Criteria:

Prior myocardial infarction (as determined by patient history and/or ECG), cardiac surgery, or severe pericardial, congenital, cardiomyopathic or valvular heart disease.
Requirement for urgent cardiac surgery.
Previous CABG or PCI.
Left bundle branch block.
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.
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.
Known or suspected aortic dissection.
Prior history of pulmonary disease requiring chronic oxygen therapy.
Pregnancy, lactating and woman of childbearing potential.
Use of investigational drugs or device within the 30 days prior to enrollment to the study. Investigational uses of approved therapies will be allowed.
Medical problem likely to preclude completion of the study.

Sites / Locations

Jessa Hospital
UZ Leuven
Semmelweis University Heart Center
John Paul II Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nitric Oxide

Placebo

Arm Description

nitric oxide for inhalation

inhalation gas

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

MI size, extent and transmurality of microvascular obstruction

MI size, extent and transmurality of microvascular obstruction measured by MRI

MI size normalized to area at risk

Myocardial perfusion at coronary angiography at the completion of PCI (corrected TIMI frame count and myocardial blush grade).

Transmurality of infarct (as average percent wall thickness in all segments showing delayed enhancement).

Myocardial perfusion(MRI).

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.

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.

Troponin T levels and CPK-MB area under the curve at 48 hours.

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.

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.

Assess the safety of inhaled NO for this use as determined by reported adverse events (including bleeding and laboratory changes).

Full Information

NCT ID

NCT01398384

First Posted

July 18, 2011

Last Updated

May 20, 2014

Sponsor

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT01398384

Brief Title

Effects of Nitric Oxide for Inhalation 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 2014

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction

Keywords

ST Elevation MI, STEMI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nitric Oxide

Arm Type

Active Comparator

Arm Description

nitric oxide for inhalation

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

inhalation gas

Intervention Type

Drug

Intervention Name(s)

Nitric Oxide

Other Intervention Name(s)

vasoKINOX 450

Intervention Description

MI size at 48-72 hours

Intervention Type

Drug

Intervention Name(s)

MI size at 48-72 hours

Intervention Description

Placebo gas

Primary Outcome Measure Information:

Title

Myocardial infarction size as a fraction of left ventricular size

Description

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.

Time Frame

48-72 hours

Secondary Outcome Measure Information:

Title

MI size, extent and transmurality of microvascular obstruction

Description

MI size, extent and transmurality of microvascular obstruction measured by MRI

Time Frame

48-72 hours

Title

MI size normalized to area at risk

Time Frame

48-72 hours

Title

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

Title

Transmurality of infarct (as average percent wall thickness in all segments showing delayed enhancement).

Time Frame

at 48 - 72 hours and 4 months

Title

Myocardial perfusion(MRI).

Time Frame

at 48-72 hours and 4 months

Title

Time Frame

48-72 hours and 4 months

Title

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

Title

Troponin T levels and CPK-MB area under the curve at 48 hours.

Time Frame

48 hours

Title

Description

Time Frame

4 months

Title

Time Frame

4 months

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). No evidence of congestive heart failure (no S3 or evidence of pulmonary edema) and normal oxygen saturation on ≤ 2L oxygen by NC. 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). Age > 18 years. Signed EC approved informed consent. Exclusion Criteria: Prior myocardial infarction (as determined by patient history and/or ECG), cardiac surgery, or severe pericardial, congenital, cardiomyopathic or valvular heart disease. Requirement for urgent cardiac surgery. Previous CABG or PCI. Left bundle branch block. 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. 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. Known or suspected aortic dissection. Prior history of pulmonary disease requiring chronic oxygen therapy. Pregnancy, lactating and woman of childbearing potential. Use of investigational drugs or device within the 30 days prior to enrollment to the study. Investigational uses of approved therapies will be allowed. Medical problem likely to preclude completion of the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefan Janssens, Prof Dr

Organizational Affiliation

UZ Leuven

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Frans Van de Werf, Prof Dr

Organizational Affiliation

UZ Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jessa Hospital

City

Hasselt

Country

Belgium

Facility Name

UZ Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Semmelweis University Heart Center

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

John Paul II Hospital

City

Krakow

ZIP/Postal Code

31-202

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

29800130

Citation

Janssens SP, Bogaert J, Zalewski J, Toth A, Adriaenssens T, Belmans A, Bennett J, Claus P, Desmet W, Dubois C, Goetschalckx K, Sinnaeve P, Vandenberghe K, Vermeersch P, Lux A, Szelid Z, Durak M, Lech P, Zmudka K, Pokreisz P, Vranckx P, Merkely B, Bloch KD, Van de Werf F; NOMI investigators. Nitric oxide for inhalation in ST-elevation myocardial infarction (NOMI): a multicentre, double-blind, randomized controlled trial. Eur Heart J. 2018 Aug 1;39(29):2717-2725. doi: 10.1093/eurheartj/ehy232.

Results Reference

derived

Links:

URL

https://lrd.kuleuven.be/onderzoekscentra/lcc/nomi/NOMISAP19May2014.pdf/at_download/file

Description

NOMI: Final Statistical Analysis Plan 19 May 2014

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Effects of Nitric Oxide for Inhalation in Myocardial Infarction Size

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