NCT07110298

Brief 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 myocardial injury degree.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

4.4 years

First QC Date

July 31, 2025

Last Update Submit

July 31, 2025

Conditions

Coronary Arterial Disease (CAD)

Outcome Measures

Primary Outcomes (2)

  • cardiovascular adverse events

    three months

  • Major cardiac adverse events

    three months follow-up

Study Arms (1)

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

unstable angian patients

You may qualify if:

  • unstable angina patients

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

Related Publications (1)

  • 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.

    PMID: 18288753BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 7, 2025

Study Start

January 1, 2019

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

August 7, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)