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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06178133

Enrollment

500

Registered

2023-12-20

Start date

2023-12-31

Completion date

2024-01-31

Last updated

2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Contacts

Primary ContactRuitao Zhang

clinicboy@126.com13001203879

Backup ContactPengxin Xie

xiepengxin2014@163.com18810793282

Outcome results