Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
NCT ID:
NCT04794868
Eligibility Criteria:
Inclusion Criteria:
1. Patients who presented with ACS and underwent invasive coronary angiography with identifiable culprit lesion
2. Patients who presented with stable ischemic heart disease and underwent invasive coronary angiography for the significant epicardial coronary stenosis
3. The patients who underwent coronary CT angiography, regardless of the reason (for example, routine healthcare check-up, or evaluation for stable angina or atypical chest pain) prior to the acute event.
4. Time limit of CCTA: 6 months \~ 3 years prior to the event.
5. Definition of ACS:
* The patients with acute myocardial infarction should meet one of the following criteria;
* Cardiac enzyme elevation "and"
* Identified culprit lesion confirmed by invasive coronary angiography, IVUS, or OCT
* The patients with unstable angina should be accompanied by the evidence of plaque rupture confirmed with invasive coronary angiography, IVUS, or OCT
Exclusion Criteria:
Exclusion criteria for Patient enrollment
* Patients with acute coronary syndrome without clear evidence of culprit lesion
* Patients with stents in two or more vessel territories prior to CCTA
* Poor quality of CCTA which is unsuitable for plaque and CFD analysis
* Patients with ACS culprit lesion in a stented vessel
* Patients with previous history of coronary artery bypass graft surgery
* Secondary myocardial infarction due to other general medical conditions, such as sepsis, arrhythmia, bleeding, etc.
* Poor quality CCTA images unsuitable for CFD analysis
* No available unprocessed CCTA data
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04794868
Study Brief:
Protocol Section:
NCT04794868