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

NCT04665817 | Unknown

• 1 other identifier: Huadong Hospital
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

coronary stenosis; coronary computed tomography angiography; hemodynamics; CT-QFR; QFR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Comparision between CT-QFR and QFR

  1.5 year

• Other common measures of diagnostic performance of CT-QFR

  1.5 year

• Correlation between CT-QFR and FFR

  1.5 year

• The comparison between CT-QFR, CCTA-derived percent diameter stenosis (CTA-DS%) and QCA-derived DS%

  1.5 year

Interventions

CT-QFR DIAGNOSTIC_TEST

CT-QFR is a novel method for evaluating the functional significance of coronary stenosis. It is calculated by coronary computed tomographic angiography images.

Also known as: Fast Computational Approach to Derive Fractional Flow Reserve From Coronary CT Angiography

QFR DIAGNOSTIC_TEST

QFR is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on two. angiographic projections.

Also known as: Quantitative Flow Ratio

FFR DIAGNOSTIC_TEST

FFR measured by pressure wire is the gold standard for evaluating the functional significance of coronary stenosis.

Also known as: Fraction Flow Reserve

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead
• Shanghai Jiao Tong University -Pulse Medical Imaging Technology Joint Lab: collaborator

Study Sites (1)

Xinkai Qu

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Related Publications (2)

• Weng T, Ding D, Li G, Guan S, Han W, Gan Q, Li M, Qi L, Li C, Chen Y, Zhang L, Li T, Chang X, Chen Y, Wijns W, Qu X, Tu S. Accuracy of coronary computed tomography angiography-derived quantitative flow ratio for onsite assessment of coronary lesions. EuroIntervention. 2024 Oct 21;20(20):e1288-e1297. doi: 10.4244/EIJ-D-24-00336.

  PMID: 39432253 DERIVED

• 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.

  PMID: 35738652 DERIVED

MeSH Terms

Conditions

Coronary Stenosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Xinkai Qu, MD,PhD

  Huadong Hospital, Department of Cardiology

  PRINCIPAL INVESTIGATOR

• Tingwen Weng, MD

  Huadong Hospital, Department of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinkai Qu, MD,PhD

CONTACT

+86 13916320399; qxkchest@126.com

Tingwen Weng, MD

CONTACT

+86 13917769721; wengtingwen@alu.fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Huadong Hospital, Department of Cardiology

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 14, 2020
• Study Start: October 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)