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

NCT06178133 | Unknown

• 1 other identifier: M2023683
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who met the inclusion criteria and those who did not meet the exclusion criteria were admitted to the Department of Cardiovascular Medicine of Peking University Third Hospital from January 1, 2019 to November 31, 2023.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Ruitao Zhang

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Ruitao Zhang

CONTACT

13001203879; clinicboy@126.com

Pengxin Xie

CONTACT

18810793282; xiepengxin2014@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 20, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share