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 @ 1:38 PM
Ignite Modification Date:
2025-12-24 @ 1:38 PM
NCT ID:
NCT07020195
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old;
* Diagnosed as MVD patient by coronary angiography (≥ 50% stenosis in ≥ 2 major vessels);
* Plan to undergo PCI or CABG treatment, and ensure that the contrast images meet the imaging quality requirements for QFR analysis;
* Voluntarily sign the informed consent form, be able to participate in randomization and cooperate in completing all follow-up visits.
Exclusion Criteria:
* Acute myocardial infarction requires emergency PCI;
* Severe left ventricular dysfunction (LVEF\<30%) or cardiogenic shock;
* The quality of coronary angiography images is poor, such as vascular overlap, respiratory artifacts, projection angles less than 25 °, or frame rates less than 15 frames per second;
* Failure of QFR analysis due to severe calcified lesions (determined by the central laboratory);
* eGFR\<30 mL/min/1.73m ² or contrast agent allergy;
* Patients using intravenous pressors, intra aortic balloon counterpulsation, or other mechanical circulatory support devices;
* Patients undergoing tracheal intubation treatment;
* Patients who have received thrombolytic therapy before admission;
* Pregnant women;
* Expected survival time\<1 year due to non cardiac reasons;
* Patients who are not expected to receive antiplatelet therapy for at least 6 months;
* Patients who have received CABG treatment in the past or plan to receive CABG treatment;
* Patients who plan to undergo any surgical procedure within 6 months;
* There are other conditions that may interfere with follow-up, such as dementia, drug abuse including drug use and drug dependence for other reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07020195
Study Brief:
Protocol Section:
NCT07020195