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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Stenosis Hemodynamics Coronary Artery Disease Coronary Computed Tomography Angiography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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CT-QFR

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

Intervention Type DIAGNOSTIC_TEST

QFR

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.

Intervention Type DIAGNOSTIC_TEST

FFR

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Fast Computational Approach to Derive Fractional Flow Reserve From Coronary CT Angiography Quantitative Flow Ratio Fraction Flow Reserve

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No