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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06178133
Other study ID # M2023683
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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