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

Last updated: January 10, 2022
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Heart Disease

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT04665817
Huadong Hospital
  • Ages 35-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. The target lesion has received coronary stent implantation or coronary artery bypassgraft.
  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 oradenosine 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 Design

Total Participants: 216
Study Start date:
October 01, 2020
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Xinkai Qu

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

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