Coronary Arterial Disease (CAD)NCT07110298
Association Between Peri-procedural Myocardial Injury and Quantitative Blood Flow Ratio
An observational study of Coronary Arterial Disease (CAD), run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
to apply angiography-based quantitative blood flow ratio to quantify the severity of the stenosed coronary artery prior to percutaneous coronary intervention, and monitor per-procedural myocardial injury based on the troponin level.Finally, to find the relationship between quantitative blood flow ratio results and… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 May 2023
- 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 85 years
- All sexes
- Adult, Older adult
Study population: unstable angian patients
Who may be able to join
- unstable angina patients
Who cannot join
- (1) multivessel diseases needed to be bypassed; (2) no track of high-sensitivity troponin I (hs-CTNI) level after PCI; (3) the elevated hs-CTNI level before PCI; (4) patients refusal to PCI; (5) side branch occlusion after PCI; (6) PCI failure with the main vessels occlusion; (7) eGRF (estimated glomerular filtration rate) less than 30ml/min/1.73m2; (8) no acquisition of QFR results because of the non-ideal angiographic quality.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
About this study
Official title: Association Between Angiography-based Quantitative Blood Flow Ratio and Peri-procedural Myocardial Injury：a Cohort Study
to apply angiography-based quantitative blood flow ratio to quantify the severity of the stenosed coronary artery prior to percutaneous coronary intervention, and monitor per-procedural myocardial injury based on the troponin level.Finally, to find the relationship between quantitative blood flow ratio results and myocardial injury degree.
- Conditions
- Coronary Arterial Disease (CAD)
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 |
|---|---|---|
| post- procedural serum hs-cTNI level more than three times of URL | cohort divided into two groups based on the post- procedural serum hs-cTNI level |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular adverse events
Measured: three months
Major cardiac adverse events
Measured: three months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Jan 2019
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110298
- Sponsor's protocol ID
- QFR AND PMI
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nienhuis MB, Ottervanger JP, Bilo HJ, Dikkeschei BD, Zijlstra F. Prognostic value of troponin after elective percutaneous coronary intervention: A meta-analysis. Catheter Cardiovasc Interv. 2008 Feb 15;71(3):318-24. doi: 10.1002/ccd.21345.
PubMed 18288753
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Angiography-based Quantitative Blood Flow Ratio and Peri-procedural Myocardial Injury：a Cohort Study
- ClinicalTrials.gov ID
- NCT07110298
- Acronym / sponsor ID
- QFR AND PMI
- Conditions
- Coronary Arterial Disease (CAD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 7 Aug 2025 (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.
to apply angiography-based quantitative blood flow ratio to quantify the severity of the stenosed coronary artery prior to percutaneous coronary intervention, and monitor per-procedural myocardial injury based on the troponin level.Finally, to find the relationship between quantitative blood flow ratio results and myocardial injury degree.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post- procedural serum hs-cTNI level more than three times of URL | – | –cohort divided into two groups based on the post- procedural serum hs-cTNI level |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- unstable angian patients
Key inclusion criteria (1 listed)
- unstable angina patients
Key exclusion criteria (1 listed)
- (1) multivessel diseases needed to be bypassed; (2) no track of high-sensitivity troponin I (hs-CTNI) level after PCI; (3) the elevated hs-CTNI level before PCI; (4) patients refusal to PCI; (5) side branch occlusion after PCI; (6) PCI failure with the main vessels occlusion; (7) eGRF (estimated glomerular filtration rate) less than 30ml/min/1.73m2; (8) no acquisition of QFR results because of the non-ideal angiographic quality.
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
cardiovascular adverse events
Time frame: three months
Major cardiac adverse events
Time frame: three months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Results publication: PubMed 18288753Nienhuis MB, Ottervanger JP, Bilo HJ, Dikkeschei BD, Zijlstra F. Prognostic value of troponin after elective percutaneous coronary intervention: A meta-analysis. Catheter Cardiovasc Interv. 2008 Feb 15;71(3):318-24. doi: 10.1002/ccd.21345.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arterial Disease (CAD), run by The First Affiliated Hospital of Xiamen University at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular adverse events (time frame: three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07110298, which also lists 1 linked publication.
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 7 Aug 2025.