Myocardial InfarctionNCT02385487
Inflammation in Type 2 Myocardial Infarction
An observational study of Myocardial Infarction and Inflammation, run by NYU Langone Health at 1 site in United States.
Trial summary
Type 2 myocardial infarction (MI) is defined as myocardial necrosis that results from an imbalance of myocardial oxygen supply and demand. Although type 2 MI is highly prevalent in patients with critical illness and strongly associated with mortality, the pathophysiology remains poorly understood. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Myocardial Infarction, Inflammation, Critical Illness
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Mar 2016
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults admitted to the Medical Intensive or Coronary Care Units (MICU or CCU)
Who may be able to join
- ≥21 years of age
- admitted to the Medical Intensive or Coronary Care Units
- sepsis or respiratory failure
- clinically indicated troponin measurement within 24 hours of ICU admission
Who cannot join
- unstable angina or Type 1 MI
- percutaneous or surgical coronary revascularization within 7 days
- heart failure exacerbation
- primary valvular disorder
- aortic dissection
- infiltrative heart disease or hypertrophic cardiomyopathy
Show all 14Show fewer
- myocarditis
- pulmonary embolism
- electrocardiogram with >1mm ST segment elevation in two consecutive leads
- serum cardiac troponin >99th percentile URL but no clear rise or fall pattern
- history of chronic inflammatory disease
- use of therapeutic-dose anticoagulants / antiplatelet agents other than aspirin
- pregnant or incarcerated
- enrolled in a competing study
Trial locations and contacts
1 site in 1 country.
About this study
Type 2 myocardial infarction (MI) is defined as myocardial necrosis that results from an imbalance of myocardial oxygen supply and demand. Although type 2 MI is highly prevalent in patients with critical illness and strongly associated with mortality, the pathophysiology remains poorly understood. Inflammation is central to the development of atherosclerosis, plaque rupture, and other subtypes of MI, but the role of inflammation in type 2 MI and myocardial necrosis has not been defined. The investigators aim to to delineate the mechanistic role of inflammation in myocardial necrosis and type 2 MI complicating critical medical illness.
- Conditions
- Myocardial Infarction, Inflammation, Critical Illness
- Keywords
- Myocardial Infarction, Inflammation, Critical Illness, Necrosis, Sepsis, Respiratory Insufficiency, Myocardial Ischemia, Cardiovascular Diseases, Heart Diseases, Vascular Diseases
- Medical subject headings
- Myocardial Infarction, Inflammation, Critical Illness, Necrosis, Sepsis, Respiratory Insufficiency, Myocardial Ischemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critical illness and type 2 MI | Critically ill adults with abnormal serum troponin I during hospitalization for critical illness. | |
| Critical illness without type 2 MI | Critically ill adults without an elevation in troponin I complicating critical illness. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukocyte-platelet aggregates
Measured: Day 1
Secondary outcomes (5)
Leukocyte-platelet aggregates
Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Measured: Day 10
Monocyte-platelet aggregates
Measured: Day 1
Monocyte-platelet aggregates
Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Measured: Day 10
Neutrophil-platelet aggregates
Measured: Day 1
Neutrophil-platelet aggregates
Participants will be followed for the duration of hospital stay, an expected average of 10 days.
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Why it stopped: Logistics and feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binita Shah, MD, MS, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385487
- Sponsor's protocol ID
- S14-01349
- Status last verified
- Jul 2015
- First submitted
- 26 Feb 2015
- Last updated
- 3 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation in Type 2 Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02385487
- Acronym / sponsor ID
- S14-01349
- Conditions
- Myocardial Infarction, Inflammation, Critical Illness
- Keywords
- Myocardial Infarction, Inflammation, Critical Illness, Necrosis, Sepsis, Respiratory Insufficiency, Myocardial Ischemia, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Logistics and feasibility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 11 Mar 2015 (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.
Type 2 myocardial infarction (MI) is defined as myocardial necrosis that results from an imbalance of myocardial oxygen supply and demand. Although type 2 MI is highly prevalent in patients with critical illness and strongly associated with mortality, the pathophysiology remains poorly understood. Inflammation is central to the development of atherosclerosis, plaque rupture, and other subtypes of MI, but the role of inflammation in type 2 MI and myocardial necrosis has not been defined. The investigators aim to to delineate the mechanistic role of inflammation in myocardial necrosis and type 2 MI complicating critical medical illness.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Critical illness and type 2 MI | – | –Critically ill adults with abnormal serum troponin I during hospitalization for critical illness. |
| Critical illness without type 2 MI | – | –Critically ill adults without an elevation in troponin I complicating critical illness. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults admitted to the Medical Intensive or Coronary Care Units (MICU or CCU)
Key inclusion criteria (4 listed)
- ≥21 years of age
- admitted to the Medical Intensive or Coronary Care Units
- sepsis or respiratory failure
- clinically indicated troponin measurement within 24 hours of ICU admission
Key exclusion criteria (14 listed)
- unstable angina or Type 1 MI
- percutaneous or surgical coronary revascularization within 7 days
- heart failure exacerbation
- primary valvular disorder
- aortic dissection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Leukocyte-platelet aggregates
Time frame: Day 1
5 secondary outcomes
Leukocyte-platelet aggregates
Time frame: Day 10
Monocyte-platelet aggregates
Time frame: Day 1
Monocyte-platelet aggregates
Time frame: Day 10
Neutrophil-platelet aggregates
Time frame: Day 1
Neutrophil-platelet aggregates
Time frame: Day 10
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
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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.
Binita Shah, MD, MS principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Inflammation, run by NYU Langone Health at 1 site in United States.
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 4 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: withdrawn, as of the sponsor's last update on 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Leukocyte-platelet aggregates (time frame: Day 1). 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 3 Jul 2015.