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

Coronary Heart Disease Clinical Trial

Official title:

Influencing Factors of the Diagnostic Accuracy of Novel Coronary Functional Evaluation Methods: a Cross-sectional Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06178133
• Other study ID #: M2023683
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: January 2024

Study information

• Verified date: November 2023
• Source: Peking University Third Hospital
• Contact: Ruitao Zhang
• Phone: 13001203879
• Email: clinicboy[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Exclusion Criteria:

• 1) Coronary artery bypass graft (CABG);

• 2) Atrial fibrillation or flutter;

• 3) Left or right coronary opening lesions;

• 4) Pregnancy or breastfeeding.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the discordance between fractional flow reserve and quantitative flow ratio	If FFR=0.80 and QFR =0.8 or FFR > 0.80 and QFR > 0.8 are consistent groups, otherwise they are inconsistent group	When the patient has completed coronary angiography and received a diagnosis