Status:
COMPLETED
DEFINing the PrEvalence and Characteristics of Coronary Artery Disease Among Patients With TYPE 2 Myocardial Infarction Using CT-FFR
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
HeartFlow, Inc.
Conditions:
Type 2 Myocardial Infarction
Eligibility:
All Genders
18+ years
Brief Summary
The primary objectives of this study include: * determine the prevalence of coronary artery disease among patients with type 2 myocardial infarction * determine the prevalence of hemodynamically sign...
Detailed Description
RECRUITMENT Patients in the Emergency Department or admitted to Massachusetts General Hospital with an elevated high-sensitivity cardiac troponin will be identified daily by the Clinical Core Laborat...
Eligibility Criteria
Inclusion
- Capable of giving informed consent
- Patients aged greater than18 years diagnosed with type 2 MI, defined based on the 4th Universal Definition of Myocardial Infarction (1), during their index hospitalization
- Type 2 MI will be defined as detection of a rise and/or fall of troponin levels with at least one value above the 99th percentile and evidence of an imbalance between myocardial oxygen supply and demand, requiring at least one of the following:
- Symptoms of acute myocardial ischemia;
- New ischemic ECG changes;
- Development of pathological Q waves;
- Imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality in a pattern consistent with an ischemic etiology
- Patients with medical precipitants of their type 2 MI or post-operative type 2 MI. A minimum of 10 patients with post-operative type 2 MI will be included to ensure a diverse clinical patient population is enrolled.
Exclusion
- Other types of MI
- Hemodynamic instability
- eGFR \<30 ml/min/1.73m2
- Pregnant or breast-feeding women
- Contrast allergy
- Pre-operative history of MI, coronary angiography or coronary revascularization for patients with post-operative type 2 MI
- Severe arrhythmias precluding optimal CT image acquisition
- Prior coronary artery bypass grafting
- Known prior left main coronary artery PCI
- Known PCI of the left coronary system combined with \>30% stenosis in the left main artery
- Known prior PCI to 2 or more major coronary vessels (i.e. left anterior descending artery, left circumflex artery, right coronary artery)
- Allergy or contraindication to nitroglycerin
Key Trial Info
Start Date :
April 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 11 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04864119
Start Date
April 11 2021
End Date
March 11 2024
Last Update
March 13 2024
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114