Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the effects of Nitric Oxide for Inhalation on Myocardial Infarction Size.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitric Oxide | Active Comparator | nitric oxide for inhalation |
|
| Placebo | Placebo Comparator | inhalation gas |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide | Drug | MI size at 48-72 hours |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| MI size, extent and transmurality of microvascular obstruction | MI size, extent and transmurality of microvascular obstruction measured by MRI | 48-72 hours |
| MI size normalized to area at risk |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stefan Janssens, Prof Dr | UZ Leuven | Principal Investigator |
| Frans Van de Werf, Prof Dr | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Hospital | Hasselt | Belgium | ||||
| UZ Leuven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29800130 | Derived | 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. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 19, 2023 | |
| Reset | Apr 12, 2024 | |
| Release | Jun 26, 2024 | |
| Reset | Oct 2, 2024 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 19, 2023 | Apr 12, 2024 | |||
| Jun 26, 2024 |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009569 | Nitric Oxide |
| ID | Term |
|---|---|
| D026361 | Reactive Nitrogen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009589 | Nitrogen Oxides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| MI size at 48-72 hours | Drug | Placebo gas |
|
| 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 |
| 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 |
| 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 |
| Troponin T levels and CPK-MB area under the curve at 48 hours. | 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. | 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. | 4 months |
| 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 |
| Leuven |
| 3000 |
| Belgium |
| Semmelweis University Heart Center | Budapest | 1122 | Hungary |
| John Paul II Hospital | Krakow | 31-202 | Poland |
| Oct 2, 2024 |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D017672 |
| Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |