Influencing Factors of the Diagnostic Accuracy of Novel Coronary Functional Evaluation Methods

Not yet recruiting

• Conditions: Coronary Heart Disease

• Registration Number: NCT06178133
• Lead Sponsor: Peking University Third Hospital

Brief Summary

In this study, patients were retrospectively included, univariate and multivariate analysis of factors affecting their diagnosis inconsistencies was performed, and a new diagnostic model was constructed by logistic regression.

Detailed Description

The evaluation of coronary function is becoming more and more important in the guidelines, in which coronary flow reserve (FFR) is the gold standard for diagnosis, but its measurement process requires the application of adenosine, vasodilator, etc. Some patients cannot be measured because of asthma and low blood pressure. A new instantaneous wave-free ratio (iFR), contrastive flow reserve fraction (cFFR) and quantitative flow fraction (QFR) have been developed for the evaluation of coronary function. However, in some patients, the new coronary function evaluation methods were inconsistent with FFR. In this study, patients were retrospectively included, univariate and multivariate analysis of factors affecting their diagnosis inconsistencies was performed, and a new diagnostic model was constructed by logistic regression.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-14
• Study Start: 2023-12
• Primary Completion: 2023-12
• Study First Submitted QC: 2023-12-11
• Last Update Submitted: 2023-12-11
• Study First Posted: 2023-12-20
• Last Update Posted: 2023-12-20
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Age above 18 and below 80 years old, regardless of gender;
• FFR was detected by coronary angiography;
• The coronary angiography images were clear, meeting the requirements of QFR analysis or detecting iFR, cFFR, and resting pd/pa during the operation.

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Exclusion Criteria

• 1. Coronary artery bypass graft (CABG);
• 2. Atrial fibrillation or flutter;
• 3. Left or right coronary opening lesions;
• 4. Pregnancy or breastfeeding.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the discordance between fractional flow reserve and quantitative flow ratio	When the patient has completed coronary angiography and received a diagnosis	If FFR≤0.80 and QFR ≤0.8 or FFR \> 0.80 and QFR \> 0.8 are consistent groups, otherwise they are inconsistent group