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Not yet recruitingNCT06178133Updated Dec 20, 2023

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

An observational study in Coronary Heart Disease, sponsored by Peking University Third Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-20.

Sponsored by Peking University Third Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
500
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 500 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

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

    Time frame: When the patient has completed coronary angiography and received a diagnosis

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06178133
Lead sponsor
Peking University Third Hospital
Responsible party
Sponsor
First posted
Dec 20, 2023
Start date
Dec 2023 (estimated)
Primary completion
Dec 2023 (estimated)
Completion
Jan 2024 (estimated)
Last update
Dec 20, 2023

Study contacts

Ruitao Zhang
Contact
clinicboy@126.com
13001203879
Pengxin Xie
Contact
xiepengxin2014@163.com
18810793282
Ruitao Zhang
study director · Peking University Third Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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