Acute Myocardial InfarctionPhase 2NOMINCT01398384
Effects of Nitric Oxide for Inhalation in Myocardial Infarction Size
A Phase 2 study testing Nitric Oxide and MI size at 48-72 hours in people with Acute Myocardial Infarction, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in 3 countries.
Trial summary
The purpose of this study is to determine the effects of Nitric Oxide for Inhalation on Myocardial Infarction Size. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Nitric Oxide and MI size at 48-72 hours
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Oct 2010to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
About this study
Official title: The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size
The purpose of this study is to determine the effects of Nitric Oxide for Inhalation on Myocardial Infarction Size.
Read the 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.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Nitric Oxide, MI size at 48-72 hours
- Keywords
- ST Elevation MI, STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
Also called vasoKINOX 450
MI size at 48-72 hours
MI size at 48-72 hoursDrug
Placebo gas
| Study group | Role | What they receive |
|---|---|---|
| Nitric Oxide | Active comparator | nitric oxide for inhalation Receives: Drug: Nitric Oxide |
| Placebo | Placebo comparator | inhalation gas Receives: Drug: MI size at 48-72 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48-72 hours
Secondary outcomes (11)
MI size, extent and transmurality of microvascular obstruction
MI size, extent and transmurality of microvascular obstruction measured by MRI
Measured: 48-72 hours
MI size normalized to area at risk
Measured: 48-72 hours
Myocardial perfusion at coronary angiography at the completion of PCI (corrected TIMI frame count and myocardial blush grade).
Measured: at completion of PCI, as expected 1 day
Transmurality of infarct (as average percent wall thickness in all segments showing delayed enhancement).
Measured: at 48 - 72 hours and 4 months
Myocardial perfusion(MRI).
Measured: at 48-72 hours and 4 months
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.
Measured: 48-72 hours and 4 months
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.
Measured: at 4 hours
Troponin T levels and CPK-MB area under the curve at 48 hours.
Measured: 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.
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.
Measured: 4 months
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.
Measured: 4 months
Assess the safety of inhaled NO for this use as determined by reported adverse events (including bleeding and laboratory changes).
Measured: during treatment gas period, an average of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startOct 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Janssens, Prof Dr, Principal investigator, UZ LeuvenFrans Van de Werf, Prof Dr, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398384
- Sponsor's protocol ID
- LCC2010.01
- Acronym
- NOMI
- Status last verified
- May 2014
- First submitted
- 18 Jul 2011
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29800130
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size
- ClinicalTrials.gov ID
- NCT01398384
- Acronym / sponsor ID
- NOMI / LCC2010.01
- Conditions
- Acute Myocardial Infarction
- Keywords
- ST Elevation MI, STEMI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitric Oxide | Active comparator | Drug: Nitric Oxidenitric oxide for inhalation |
| Placebo | Placebo comparator | Drug: MI size at 48-72 hoursinhalation gas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric OxideAlso: vasoKINOX 450MI size at 48-72 hours | Drug | Nitric Oxide |
| MI size at 48-72 hoursPlacebo gas | Drug | Placebo |
Primary outcome
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.
11 secondary outcomes
MI size, extent and transmurality of microvascular obstruction
Time frame: 48-72 hours
MI size normalized to area at risk
Time frame: 48-72 hours
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
Transmurality of infarct (as average percent wall thickness in all segments showing delayed enhancement).
Time frame: at 48 - 72 hours and 4 months
Myocardial perfusion(MRI).
Time frame: at 48-72 hours and 4 months
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
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
Troponin T levels and CPK-MB area under the curve at 48 hours.
Time frame: 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.
Time frame: 4 months
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
- Derived from this study: PubMed 29800130Janssens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Janssens, Prof Dr principal investigator
UZ Leuven
Frans Van de Werf, Prof Dr principal investigator
UZ Leuven
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitric Oxide and MI size at 48-72 hours in people with Acute Myocardial Infarction, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Hungary, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial infarction size as a fraction of left ventricular size (time frame: 48-72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01398384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2014.