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

NCT ID: NCT06178133

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-01-31

Brief Summary

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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

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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.

Conditions

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Coronary Heart Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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FFR

In this single-center cross-sectional study, we included patients with non-acute myocardial infarction who were admitted to the Department of Cardiology at Peking University Third Hospital for FFR testing from January 2019 to December 2021.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ruitao Zhang

Role: STUDY_DIRECTOR

Peking University Third Hospital

Central Contacts

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Ruitao Zhang

Role: CONTACT

Phone: 13001203879

Email: [email protected]

Pengxin Xie

Role: CONTACT

Phone: 18810793282

Email: [email protected]

Other Identifiers

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M2023683

Identifier Type: -

Identifier Source: org_study_id