Acute Myocardial InfarctionPhase 2NOMINCT00568061
Nitric Oxide in Myocardial Infarction Size
A Phase 2 study testing Nitric Oxide in people with Acute Myocardial Infarction and ST Elevation MI, run by Mallinckrodt at 14 sites in 3 countries.
Trial summary
The purpose of this study is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size at 48-72 hours in patients presenting with an ST segment elevation MI (STEMI) who undergo successful percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, ST Elevation MI, STEMI
- What is being tested?
- Nitric Oxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Jun 2006to Jun 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 and electrocardiographic evidence of ST elevation
- No clinical evidence of congestive heart failure
- All patients must undergo successful percutaneous coronary intervention for thrombolysis in myocardial infarction (TIMI) 0 or 1 coronary flow with resulting TIMI 2 or 3 flow
- Greater than 18 years of age
- Signed Institutional Review Board (IRB) approved informed consent
Who cannot join
- Prior myocardial infarction
- Requirement for urgent cardiac surgery
- Previous coronary artery bypass graft (CABG) or primary coronary intervention (PCI)
- Left bundle branch block
- Heart block that is expected to require a temporary pacemaker for greater than 72 hours
- Prior use of thrombolytic therapy for the current event
Show all 14Show fewer
- Unable to tolerate magnetic resonance imaging or unable to tolerate gadolinium contrast media, including patients with a calculated creatinine clearance less than 60 ml/min/1.73m² Body Surface Area (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
- Neutropenia (WBC <2000 (mm)³), Anemia (HCT <30%, Thrombocytopenia (Thrombocytes <50,000 (mm)³). It is not necessary to confirm blood counts prior to start of study drug in the absence of clinical suspicion.
- Known or suspected aortic dissection.
- Prior history of pulmonary disease requiring chronic oxygen therapy.
- Pregnancy, lactating, and women of childbearing potential.
- Medical problem likely to preclude completion of the study.
- Use of investigational drugs or device within the 30 days prior to enrollment
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
United States11 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60611
LeBauer Cardiology
Greensboro, North Carolina, 27401
University of Kansas Hospital
Kansas City, Kansas, 66160
Baptist Cardiac & Vascula Institute
Miami, Florida, 33176
Providence Hospital
Mobile, Alabama, 36608
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
UPMC Cardiovascular Institute
Pittsburgh, Pennsylvania, 15213
Central Utah Imaging
Provo, Utah, 84604
Jack D. Weiler Hospital
The Bronx, New York, 10467
Montefiore Medical Center
The Bronx, New York, 10467
Canada2 sites
University of Alberta Hospital
Edmonton, Alberta, TGG 2B7
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: The Effects of Nitric Oxide for Inhalation on Myocardial Infarction Size
The purpose of this study is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size at 48-72 hours in patients presenting with an ST segment elevation MI (STEMI) who undergo successful percutaneous coronary intervention.
Read the detailed description
The purpose of the trial is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size as a fraction of left ventricular (LV) size at 48-72 hours in patients presenting with an ST segment elevation MI who undergo successful percutaneous coronary intervention (PCI).
The primary endpoint for this study will be myocardial infarction size as a fraction of left ventricular size at 48-72 hours as measured by contrast-enhanced cardiac MRI.
- Conditions
- Acute Myocardial Infarction, ST Elevation MI, STEMI
- Being tested
- Nitric Oxide, Placebo
- Keywords
- INOT44, NOMI
- 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 INOmax®
Nitric oxide for inhalation
PlaceboDrug
Also called Nitrogen gas
Nitrogen gas (placebo) for inhalation
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Nitric Oxide | Experimental | Inhaled Nitric oxide administered at 80 parts per million (ppm) Receives: Drug: Nitric Oxide |
| Placebo | Placebo comparator | Inhaled nitrogen gas (Placebo) administered at 80 ppm Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size
The primary endpoint - mean percent of the myocardial infarction size to the fraction of left ventricular size at 48-72 hours was measured by contrast-enhanced cardiac Magnetic Resonance Imaging (MRI).
Measured: 48-72 hours
Secondary outcomes (10)
Myocardial Infarction (MI) Size at 48-72 Hours
Measured: 48-72 hours
MI Size Normalized to Area at Risk
Measured: 48-72 hours
Myocardial Perfusion at Coronary Angiography
Measured: at completion of primary coronary intervention (PCI)
Infarct Transmurality
Measured: 48-72 hours and 4 months
Global & Regional Left Ventricular (LV) Function and LV Mass
Measured: 48-72 hours and 4 months
Change in Global LV Function and Mass
Measured: between 48-72 hours and 4 months
MI Size as a Fraction of LV Size
Measured: 4 months
Resolution of ST Segment Elevation Compared With That Observed at Enrollment
Measured: 4 hours
Troponin T Levels and CPK-MB Area Under the Curve
Measured: 48 hours
Change in Adverse Remodeling Parameters Compared With 48-72 Hrs: Changes in LV End-diastolic Vol, End-systolic Vol, 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startJun 2006
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Slow Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Baldassarre, MD, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568061
- Sponsor's protocol ID
- INOT 44
- Acronym
- NOMI
- Status last verified
- May 2016
- First submitted
- 3 Dec 2007
- Last updated
- 21 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. 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
- NCT00568061
- Acronym / sponsor ID
- NOMI / INOT 44
- Conditions
- Acute Myocardial Infarction, ST Elevation MI, STEMI
- Keywords
- INOT44, NOMI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Enrollment
- Enrolment
- 29 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 5 Dec 2007 (estimated)
- Results
- Posted 27 Aug 2010
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 assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size at 48-72 hours in patients presenting with an ST segment elevation MI (STEMI) who undergo successful percutaneous coronary intervention.
Detailed description
The purpose of the trial is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size as a fraction of left ventricular (LV) size at 48-72 hours in patients presenting with an ST segment elevation MI who undergo successful percutaneous coronary intervention (PCI).
The primary endpoint for this study will be myocardial infarction size as a fraction of left ventricular size at 48-72 hours as measured by contrast-enhanced cardiac MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Nitric Oxide | Experimental | Drug: Nitric OxideInhaled Nitric oxide administered at 80 parts per million (ppm) |
| Placebo | Placebo comparator | Drug: PlaceboInhaled nitrogen gas (Placebo) administered at 80 ppm |
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 and electrocardiographic evidence of ST elevation
- No clinical evidence of congestive heart failure
- All patients must undergo successful percutaneous coronary intervention for thrombolysis in myocardial infarction (TIMI) 0 or 1 coronary flow with resulting TIMI 2 or 3 flow
- Greater than 18 years of age
- Signed Institutional Review Board (IRB) approved informed consent
Key exclusion criteria (14 listed)
- Prior myocardial infarction
- Requirement for urgent cardiac surgery
- Previous coronary artery bypass graft (CABG) or primary coronary intervention (PCI)
- Left bundle branch block
- Heart block that is expected to require a temporary pacemaker for greater than 72 hours
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: INOmax®Nitric oxide for inhalation | Drug | Inhaled Nitric Oxide |
| PlaceboAlso: Nitrogen gasNitrogen gas (placebo) for inhalation | Drug | Placebo |
Primary outcome
Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size
Time frame: 48-72 hours
The primary endpoint - mean percent of the myocardial infarction size to the fraction of left ventricular size at 48-72 hours was measured by contrast-enhanced cardiac Magnetic Resonance Imaging (MRI).
10 secondary outcomes
Myocardial Infarction (MI) Size at 48-72 Hours
Time frame: 48-72 hours
MI Size Normalized to Area at Risk
Time frame: 48-72 hours
Myocardial Perfusion at Coronary Angiography
Time frame: at completion of primary coronary intervention (PCI)
Infarct Transmurality
Time frame: 48-72 hours and 4 months
Global & Regional Left Ventricular (LV) Function and LV Mass
Time frame: 48-72 hours and 4 months
Change in Global LV Function and Mass
Time frame: between 48-72 hours and 4 months
MI Size as a Fraction of LV Size
Time frame: 4 months
Resolution of ST Segment Elevation Compared With That Observed at Enrollment
Time frame: 4 hours
Troponin T Levels and CPK-MB Area Under the Curve
Time frame: 48 hours
Change in Adverse Remodeling Parameters Compared With 48-72 Hrs: Changes in LV End-diastolic Vol, End-systolic Vol, End-diastolic Myocardial Wall Thickness in Infarct, Peri-infarct and Remote Areas, and in Sphericity Index at End-diastole and End-systole
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
James Baldassarre, MD study director
Mallinckrodt
14 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 in people with Acute Myocardial Infarction and ST Elevation MI, run by Mallinckrodt at 14 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 14 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: stopped early, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada, Belgium. 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?
Yes. Results are posted in the registry (first posted 27 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Percent of Myocardial Infarction Size to the 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?
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 Nov 2019.