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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Coronary Stenosis; Hemodynamics; Coronary Computed Tomography Angiography
• Intervention / Treatment: Diagnostic test: CT-QFR; Diagnostic test: QFR; Diagnostic test: FFR

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.

• Study Type: Observational
• Enrollment (Anticipated): 216

Contacts and Locations

• Study Contact: Name: Xinkai Qu, MD,PhD; Phone Number: +86 13916320399; Email: qxkchest@126.com
• Study Contact Backup: Name: Tingwen Weng, MD; Phone Number: +86 13917769721; Email: wengtingwen@alu.fudan.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Xinkai Qu
      • Contact: Xinkai Qu, MD,PhD; Phone Number: +86 13916320399; Email: qxkchest@126.com
      • Contact: Tingwen Weng, MD; Phone Number: +86 13917769721; Email: wengtingwen@alu.fudan.edu.cn
      • Principal Investigator: Xinkai Qu, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of CT-QFR	Diagnostic accuracy of on-site CT-QFR in identifying physiologically significant coronary artery stenosis, using FFR as the reference standard. Presence of hemodynamically-significant coronary artery stenosis : FFR <= 0.80.	1.5 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparision between CT-QFR and QFR	Use FFR as a reference standard to validate the non-inferiority of CT-QFR compared with QFR in the vessels without extensively calcified lesions defined by the combination of a cross-sectional calcium arc >90° and a thickness >1.5 mm. For CT-QFR, QFR and FFR evaluations, vessels with <=0.80 are regarded as having hemodynamically significant CAD.	1.5 year
Other common measures of diagnostic performance of CT-QFR	Other common measures of diagnostic performance of CT-QFR, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) at the patient level compared with FFR as the reference standard. Presence of hemodynamically-significant coronary artery stenosis : FFR <= 0.80.	1.5 year
Correlation between CT-QFR and FFR	Pearson correlation or spearman's correlation will be used to quantify the correlations between CT-QFR and FFR. Agreements between CT-QFR and FFR will be assessed by Bland-Altman plot. The correlation coefficient r=0-0.2 represents very weak or no correlation. 0.2-0.4 represents weak correlation. 0.4-0.6 represents moderate correlation. 0.6-0.8 represents strong correlation. 0.8-1.0 represents very strong correlation.	1.5 year
The comparison between CT-QFR, CCTA-derived percent diameter stenosis (CTA-DS%) and QCA-derived DS%	The comparison of the discrimination ability between CT-QFR, CCTA-derived percent diameter stenosis (CTA-DS%), and QCA-derived DS% for identifying physiologically significant stenosis with FFR as the reference standard. Presence of hemodynamically-significant coronary artery stenosis : FFR <= 0.80.	1.5 year

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Shanghai Jiao Tong University -Pulse Medical Imaging Technology Joint Lab
• Investigators: Principal Investigator: Xinkai Qu, MD,PhD, Huadong Hospital, Department of Cardiology; Principal Investigator: Tingwen Weng, MD, Huadong Hospital, Department of Cardiology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: hemodynamics; QFR; coronary stenosis; coronary computed tomography angiography; CT-QFR
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Coronary Stenosis
• Other Study ID Numbers: Huadong Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No