Inflammation in Type 2 Myocardial Infarction

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 Overview

• Status: Withdrawn
• Conditions: Myocardial Infarction; Inflammation; Critical Illness

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Bellevue Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults admitted to the Medical Intensive or Coronary Care Units (MICU or CCU)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Leukocyte-platelet aggregates	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leukocyte-platelet aggregates	Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Day 10
Monocyte-platelet aggregates		Day 1
Monocyte-platelet aggregates	Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Day 10
Neutrophil-platelet aggregates		Day 1
Neutrophil-platelet aggregates	Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Day 10

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
EndoPAT score		Day 1
EndoPAT score	Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Day 10
surface L-selectin		Day 1
surface L-selectin	Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Day 10
soluble L-selectin		Day 1
soluble L-selectin	Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Day 10
surface CD11b		Day 1
surface CD11b	Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Day 1

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Binita Shah, MD, MS, NYU School of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: March 5, 2015
• First Posted (Estimate): March 11, 2015

Study Record Updates

• Last Update Posted (Estimate): July 3, 2015
• Last Update Submitted That Met QC Criteria: July 1, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Inflammation; Vascular Diseases; Cardiovascular Diseases; Sepsis; Critical Illness; Myocardial Infarction; Respiratory Insufficiency; Necrosis; Heart Diseases; Myocardial Ischemia
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Myocardial Infarction; Infarction; Inflammation; Critical Illness
• Other Study ID Numbers: S14-01349