Inflammation in Type 2 Myocardial Infarction

NCT ID: NCT02385487

Last Updated: 2015-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction Inflammation Critical Illness

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Critical illness and type 2 MI

Critically ill adults with abnormal serum troponin I during hospitalization for critical illness.

No interventions assigned to this group

Critical illness without type 2 MI

Critically ill adults without an elevation in troponin I complicating critical illness.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* ≥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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Binita Shah, MD, MS

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

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Bellevue Hospital Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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S14-01349

Identifier Type: -

Identifier Source: org_study_id

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