DEFINing the PrEvalence and Characteristics of Coronary Artery Disease Among Patients With TYPE 2… (NCT04864119) | Clinical Trial Compass
CompletedNot Applicable
DEFINing the PrEvalence and Characteristics of Coronary Artery Disease Among Patients With TYPE 2 Myocardial Infarction Using CT-FFR
United States50 participantsStarted 2021-04-11
Plain-language 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 significant stenosis among patients with type 2 myocardial infarction
The investigators hypothesize that patients with type 2 myocardial infarction will have a high burden of coronary artery plaque and a high prevalence of obstructive coronary artery disease with hemodynamic significance.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of obstructive coronary artery disease
Timeframe: 1 year
2
Prevalence of hemodynamically significant stenosis