Clinical trial NCT02385487: Inflammation in Type 2 Myocardial Infarction
Official title: Inflammation in Type 2 Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Myocardial Infarction
Inflammation
Critical Illness
Keywords: Myocardial Infarction
Inflammation
Critical Illness
Necrosis
Sepsis
Respiratory Insufficiency
Myocardial Ischemia
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults admitted to the Medical Intensive or Coronary Care Units (MICU or CCU)

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Leukocyte-platelet aggregates
timeFrame: Day 1
Secondary outcomes:
measure: Leukocyte-platelet aggregates
timeFrame: Day 10
measure: Monocyte-platelet aggregates
timeFrame: Day 1
measure: Monocyte-platelet aggregates
timeFrame: Day 10
measure: Neutrophil-platelet aggregates
timeFrame: Day 1
measure: Neutrophil-platelet aggregates
timeFrame: Day 10
Other outcomes:
measure: EndoPAT score
timeFrame: Day 1
measure: EndoPAT score
timeFrame: Day 10
measure: surface L-selectin
timeFrame: Day 1
measure: surface L-selectin
timeFrame: Day 10
measure: soluble L-selectin
timeFrame: Day 1
measure: soluble L-selectin
timeFrame: Day 10
measure: surface CD11b
timeFrame: Day 1
measure: surface CD11b
timeFrame: Day 1
Locations:
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Binita Shah, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: