Inflammation in Type 2 Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

Inflammation in Type 2 Myocardial Infarction

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02385487
• Other study ID #: S14-01349
• Status: Withdrawn
• Phase: N/A
• First received: February 26, 2015
• Last updated: July 1, 2015
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: July 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Infarction
• Inflammation
• Myocardial Infarction

Locations

Country	Name	City	State
United States	Bellevue Hospital Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EndoPAT score		Day 1	No
Other	EndoPAT score	Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Day 10	No
Other	surface L-selectin		Day 1	No
Other	surface L-selectin	Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Day 10	No
Other	soluble L-selectin		Day 1	No
Other	soluble L-selectin	Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Day 10	No
Other	surface CD11b		Day 1	No
Other	surface CD11b	Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Day 1	No
Primary	Leukocyte-platelet aggregates		Day 1	No
Secondary	Leukocyte-platelet aggregates	Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Day 10	No
Secondary	Monocyte-platelet aggregates		Day 1	No
Secondary	Monocyte-platelet aggregates	Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Day 10	No
Secondary	Neutrophil-platelet aggregates		Day 1	No
Secondary	Neutrophil-platelet aggregates	Participants will be followed for the duration of hospital stay, an expected average of 10 days.	Day 10	No