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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT04569669
Eligibility Criteria:
Inclusion Criteria:
Subjects that participate in this study must fulfill all the following criteria:
General inclusion criteria:
* Age ≥18 years and ≤ 80 years;
* Subject providing written informed consent;
* After the researcher assessed the suspected presence of coronary artery stenosis, coronary angiography and CCTA examination were proposed.
Angiographic inclusion criteria:
* CCTA inspection should be performed on instruments with at least 64 multidetector rows;
* CCTA images are clear and readable;
* The diameter of coronary artery lesion stenosis was measured by CCTA image with 30%-90%;
* The reference vessel diameter of coronary stenosis was ≥2.5mm by CCTA imaging.
Exclusion Criteria:
If subjects fulfill any of below criteria, this subject shall be exclude from this study.
General exclusion criteria:
* Pregnant and breast-feeding women;
* Previous ST-segment elevation myocardial infarction 30 days before CCTA examination, and a history of non-ST-segment elevation myocardial infarction 7 days before CCTA examination;
* Prior Coronary Artery Bypass Graft（CABG）,Pacemaker, Implantable Cardioverter Defibrillator（ICD）, Artificial Valve Implantation;
* Hypertrophic obstructive cardiomyopathy;
* Heart failure(NYHA≥III or Left Ventricular Ejection Fraction（LVEF）\< 40%);
* Atrial fibrillation, supraventricular tachycardia, ventricular tachycardia and other arrhythmias;
* Body mass index \>35kg/m2;
* Serum creatinine \>178µmol/L or 2mg/dl;
* Allergies or contraindications to contrast agents are known;
* Subject who received Nicorandil within 2 weeks prior to invasive FFR examination;
* Any other conditions that are not suitable for the study.
Angiographic exclusion criteria:
* The quality of CT imaging is not good enough to extract coronary blood vessel trees;
* Visual measurement of coronary lesion diameter stenosis \> 90% by CCTA imaging;
* The target lesions were diffuse lesions, and the lesion length was ≥ 30mm (visual measurement);
* There were ≥ 2 stenosis lesions in the target vessel;
* Stent implantation in the target vessel;
* Lesions involving aneurysms or myocardial Bridges;
* The target vessel is very tortuous and it is difficult to predict the passage of the pressure guide wire.
* Left main disease;
* Patients with acute coronary syndrome after CCTA examination and before invasive FFR examination;
* Severe calcification(i.e Diffuse calcification ,Local or segmental calcification)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04569669
Study Brief:
Protocol Section:
NCT04569669