NCT04864119Completed
DEFINing the PrEvalence and Characteristics of Coronary Artery Disease Among Patients With TYPE 2 Myocardial Infarction Using CT-FFR
Source: ClinicalTrials.gov · Last updated 13 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 50 (actual)
- First submitted
- 23 Apr 2021
- Start date
- 11 Apr 2021
- Primary completion date
- 3 Feb 2023
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT04864119
What you commit to
- Study type: Observational
- Participants enrolled: 50
- From 11 Apr 2021 to the primary completion date, 3 Feb 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior coronary artery bypass grafting
- Known prior left main coronary artery PCI
- Known prior PCI to 2 or more major coronary vessels (i.e. left anterior descending artery, left circumflex artery, right coronary artery)
Other illness
- 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
- Allergy or contraindication to nitroglycerin
Lab values
- eGFR \<30 ml/min/1.73m2
Other
- Other types of MI
- Hemodynamic instability
- Pregnant or breast-feeding women
- Known PCI of the left coronary system combined with \>30% stenosis in the left main artery
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.