Effects of Nitric Oxide for Inhalation in Myocardial Infarction Size

NCT01398384 | Completed Phase 2 DMC

• 1 other identifier: LCC2010.01
• Study Type: interventional
• Target: 250
• Locations: 3 countries
• Sites: 4

Brief Summary

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

Conditions

Acute Myocardial Infarction

Keywords

ST Elevation MI; STEMI

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• MI size, extent and transmurality of microvascular obstruction

  48-72 hours

• MI size normalized to area at risk

  48-72 hours

• 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

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

  at 48 - 72 hours and 4 months

• Myocardial perfusion(MRI).

  at 48-72 hours and 4 months

Study Arms (2)

Nitric Oxide

ACTIVE COMPARATOR

nitric oxide for inhalation

Drug: Nitric Oxide

Placebo

PLACEBO COMPARATOR

inhalation gas

Drug: MI size at 48-72 hours

Interventions

Nitric Oxide DRUG

MI size at 48-72 hours

Also known as: vasoKINOX 450

Nitric Oxide

MI size at 48-72 hours DRUG

Placebo gas

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (4)

Jessa Hospital

Hasselt, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Semmelweis University Heart Center

Budapest, 1122, Hungary

Location

John Paul II Hospital

Krakow, 31-202, Poland

Location

Related Publications (1)

• 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.

  PMID: 29800130 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Stefan Janssens, Prof Dr

  UZ Leuven

  PRINCIPAL INVESTIGATOR

• Frans Van de Werf, Prof Dr

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 20, 2011
• Study Start: October 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

PL (1); BE (2); HU (1)