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:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT05009667
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged 18 years and above, 80 years old and below, with no gender limitation;
2. Patients with stable or unstable angina or suspected myocardial ischemia;
3. Patients voluntarily participated in this clinical trial and signed an informed consent form;
4. Target coronary with \<50% diameter stenosis (DS%) by visual estimation.
Exclusion Criteria:
1. Patients with suspected acute myocardial infarction;
2. Patients with old myocardial infarction;
3. Patients with primary or secondary cardiomyopathy;
4. Patients with primary or secondary heart valve disease;
5. Patients with severe cardiac insufficiency and LVEF≤35%;
6. Patients with renal insufficiency (eGFR\<60ml/min (1.73m\^2)) or patients undergoing dialysis;
7. Patients who are allergic to iodine contrast agents, adenosine, and ATP;
8. Patients with severe organ disease or life expectancy less than 24 months;
9. Patients who are participating in other clinical studies of investigational drugs or devices and have not reached their primary endpoint;
10. The patient who has other conditions that are not suitable for clinical trials;
11. Patients with coronary artery involved in coronary fistula and myocardial bridge;
12. The contrast media is not filled, the blood vessels are overlapped, or the target blood vessel is severely distorted, and the lesion location cannot be fully exposed, or the image quality is poor and cannot be recognized;
13. Left main coronary artery disease and right coronary artery orifice disease;
14. After angiography, the investigator believes that the patient cannot tolerate any of the detection methods between caIMR and IMR;
15. The investigator believes that the patient is not suitable for clinical trials after angiography;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05009667
Study Brief:
Protocol Section:
NCT05009667