Association Between Peri-procedural Myocardial Injury and... | NCT07110298

Studies
Association Between Peri-procedural Myocardial Injury and Quantitative Blood Flow Ratio

NCT07110298

Sponsor

The First Affiliated Hospital of Xiamen University

Status

Completed

Last Update Posted

Aug 7, 2025Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Coronary Arterial Disease (CAD)

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

May 31, 2023Actual

Completion Date

May 31, 2023Actual

First Submitted Date

Jul 31, 2025

First Submission Date that Met QC Criteria

Jul 31, 2025

First Posted Date

Aug 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2025

Last Update Posted Date

Aug 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cardiovascular adverse events		three months
Major cardiac adverse events		three months follow-up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

unstable angina patients

Exclusion Criteria:

(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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

unstable angian patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the First Affiliated Hospital of Xiamen University		Xiamen	Fujian	361003	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18288753	Result	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.