Coronary Heart DiseaseNCT06178133
Influencing Factors of the Diagnostic Accuracy of Novel Coronary Functional Evaluation Methods
An observational study of Coronary Heart Disease, run by Peking University Third Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 1) Coronary artery bypass graft (CABG);
- 2) Atrial fibrillation or flutter;
- 3) Left or right coronary opening lesions;
- 4) Pregnancy or breastfeeding.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Influencing Factors of the Diagnostic Accuracy of Novel Coronary Functional Evaluation Methods: a Cross-sectional Study
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.
- Conditions
- Coronary Heart Disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: When the patient has completed coronary angiography and received a diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruitao Zhang, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178133
- Sponsor's protocol ID
- M2023683
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influencing Factors of the Diagnostic Accuracy of Novel Coronary Functional Evaluation Methods: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06178133
- Acronym / sponsor ID
- M2023683
- Conditions
- Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 1) Coronary artery bypass graft (CABG);
- 2) Atrial fibrillation or flutter;
- 3) Left or right coronary opening lesions;
- 4) Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the discordance between fractional flow reserve and quantitative flow ratio
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruitao Zhang study director
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruitao Zhang (13001203879, clinicboy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the discordance between fractional flow reserve and quantitative flow ratio (time frame: When the patient has completed coronary angiography and received a diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.