Clinical trial NCT04665817: Diagnostic Accuracy of CCTA-derived Versus AngiogRaphy-dErived QuantitativE Flow Ratio (CAREER) Study
Official title: Diagnostic Accuracy of CCTA-derived Versus AngiogRaphy-dErived QuantitativE Flow Ratio Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Stenosis
Hemodynamics
Coronary Artery Disease
Coronary Computed Tomography Angiography
Keywords: coronary stenosis
coronary computed tomography angiography
hemodynamics
CT-QFR
QFR
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University -Pulse Medical Imaging Technology Joint Lab
First posted: 2020-12-14
Enrollment: 216
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrolled patients are adults with suspected CAD who underwent clinically indicated ICA after CT which indicates moderate coronary artery stenosis.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic performance of CT-QFR
timeFrame: 1.5 year
Secondary outcomes:
measure: Comparision between CT-QFR and QFR
timeFrame: 1.5 year
measure: Other common measures of diagnostic performance of CT-QFR
timeFrame: 1.5 year
measure: Correlation between CT-QFR and FFR
timeFrame: 1.5 year
measure: The comparison between CT-QFR, CCTA-derived percent diameter stenosis (CTA-DS%) and QCA-derived DS%
timeFrame: 1.5 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinkai Qu
state: Shanghai
Study officials:
affiliation: Huadong Hospital, Department of Cardiology
name: Xinkai Qu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Huadong Hospital, Department of Cardiology
name: Tingwen Weng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weng T, Gan Q, Li Z, Guan S, Han W, Zhai X, Li M, Qi L, Li C, Chen Y, Zhang L, Chang X, Tu S, Qu X. Diagnostic accuracy of CCTA-derived versus angiography-derived quantitative flow ratio (CAREER) study: a prospective study protocol. BMJ Open. 2022 Jun 23;12(6):e055481. doi: 10.1136/bmjopen-2021-055481.