Diagnostic Accuracy of CCTA-derived Versus AngiogRaphy-dErived QuantitativE Flow Ratio (CAREER) Study

Fudan University

Status: Unknown

Conditions: Coronary Artery Disease; Coronary Stenosis; Coronary Computed Tomography Angiography; Hemodynamics

Treatments: Diagnostic Test: QFR; Diagnostic Test: FFR; Diagnostic Test: CT-QFR

Study type: Observational

Funder types: Other

Identifiers

NCT04665817

Huadong Hospital

Details and patient eligibility

About

To perform CT-QFR, invasive coronary angiography, FFR, and QFR tests on patients with moderate coronary stenosis after coronary CTA examination. Use FFR as a reference to verify the diagnostic performance of CT-QFR, and compare it with QFR.

Full description

This study is a prospective and single-center trial in China.It intends to enroll 216 patients with coronary artery disease whose coronary artery is determined to be 30-90% stenosis after coronary CT scan. CT image data will be imported for CT-QFR detection and undergo coronary angiography within 30 days. Quantitative analysis of coronary angiography (QCA) was performed with the degree of coronary stenosis. FFR and QFR were detected during the operation. Use FFR as a reference standard to verify the diagnostic performance of CT-QFR and QFR. The primary endpoint is the diagnostic accuracy of CT-QFR in identifying hemodynamically significant coronary stenosis with FFR as the reference standard. Major secondary endpoint is the non-inferiority of CT-QFR compared with QFR in the patients without extensively calcified lesions. The completion of the project will provide patients with a practical non-invasive assessment method of coronary heart disease which provides the best treatment strategy.

Enrollment: 216 estimated patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Coronary CT angiography indicates that >= 1 stenosis with percent diameter stenosis between 30%-90% in a vessel >= 2mm.
2. The invasive coronary angiography should be less than 30 days after the coronary CT angiography.

Exclusion criteria

1. The target lesion has received coronary stent implantation or coronary artery bypass graft.
2. Target lesion involves myocardial bridge.
3. Severe heart failure (NYHA ≥III).
4. Renal function is seriously damaged (eGFR<30 ml/min/1.73m2).
5. Those who are contraindicated to use contrast agents, beta blockers, nitrates or adenosine drugs.
6. Acute myocardial infarction within 1 month.
7. The image quality of CTA or coronary angiography cannot be assessed.
8. Any factors that affect the image quality of coronary CTA and coronary angiography, such as frequent premature contractions, atrial fibrillation, etc.