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 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT05497466
Eligibility Criteria:
Inclusion Criteria:
* Age: Patient aged older than 18;
* Deny previous cardiovascular history；
* Atypical or typical complaints of angina and referred for CCTA to rule out CAD with Iopromide 370 mgI/ml by clinicians
* Possibility of 'flash' mode scan: patient heart rate below 70 beats per minute and regular rhythm；
* Patients or families are able to understand the study protocol and willing to participate in the study and provide written informed consent.
Exclusion Criteria:
* Any contraindications for prospective ECG gate-control CT coronary angiography, including：
1. Inability to perform a breath hold for at least the expected scan time；
2. Unstable angina；
3. Hemodynamic instability；
4. Pregnant or lactating women；
5. Renal insufficiency (defined as eGFR\<30 ml/min/1.73m2);
6. Previous history of adverse reactions to iodinated contrast agents；
7. Confirmed or suspected hyperthyroidism or pheochromocytoma；
8. Atrial fibrillation or arrhythmia; severe congestive heart failure (class IV according to NYHA classification of cardiac function)；
* History of CAD
* Patients undergoing PCI before coronary CTA examination, or patients with a previous history of heart bypass surgery
* Insufficient cannula venous access (preferred 18G, minimal 20G cannula)；
* Patients who are participating other clinical studies。
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05497466
Study Brief:
Protocol Section:
NCT05497466