Predictive Value of Combining AccuIMR and AccuFFR in Pati... | NCT06435728

Studies
Predictive Value of Combining AccuIMR and AccuFFR in Patients With STEMI

NCT06435728

Sponsor

Peking University Third Hospital

Status

Unknown status

Last Update Posted

May 30, 2024Actual

Enrollment

1,297Actual

Phase

Not provided

Conditions

Acute ST Segment Elevation Myocardial Infarction
Prognosis

Interventions

AccuIMR and AccuFFR

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

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Actual

Primary Completion Date

Apr 30, 2024Actual

Completion Date

May 30, 2024Estimated

First Submitted Date

May 26, 2024

First Submission Date that Met QC Criteria

May 26, 2024

First Posted Date

May 30, 2024Actual

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

May 26, 2024

Last Update Posted Date

May 30, 2024Actual

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

Patients with acute myocardial infarction were enrolled retrospectively. The fractional flow reserve (AccuFFR) and microcirculatory resistance index (AccuIMR) based on coronary angiography were analyzed, and the relationship between FFR and IMR and the prognosis of patients with acute myocardial infarction was analyzed

Detailed Description

We retrospectively enrolled STEMI patients who underwent PCI in Peking University Third Hospital. The fractional flow reserve (AccuFFR) and microcirculatory resistance index (AccuIMR) based on coronary angiography were obtained by analyzing the coronary angiography images. The prognosis of patients was obtained by searching inpatient and outpatient systems and telephone follow-up. The relationship between AccuFFR, AccuIMR and prognosis was statistically analyzed

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

1,297Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
STEMI		Patients with STEMI who underwent primary PCI and were hospitalized at Peking University Third Hospital between January 2017 and March 2022	Diagnostic Test: AccuIMR and AccuFFR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AccuIMR and AccuFFR	Diagnostic Test	AccuFFR and AccuIMR were obtained by reviewing coronary angiography at the time of primary PCI	STEMI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACE	cardiovascular death, all-cause death, readmission for heart failure (HF), and recurrent coronary events	3 years after myocardial infarction

Secondary Outcomes

Measure	Description	Time Frame
recurrent coronary events	nonfatal myocardial infarction, unplanned PCI, and unplanned coronary artery bypass grafting	3 years after myocardial infarction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age of >18 years;
Onset-to-treatment time of ≤12 h, meeting the diagnostic criteria for STEMI;
underwent primary PCI within 12 h of symptom onset and achieved successful PCI in the culprit vessel;
Availability of complete clinical data

Exclusion Criteria:

severe tortuosity and overlap of the target vessel;
poor-quality coronary angiography images;
missing two coronary angiography images >25° apart

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with STEMI who underwent primary PCI and were hospitalized at Peking University Third Hospital between January 2017 and March 2022.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ming Cui, Dorctor	Peking University Third Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital		Beijing			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39922306	Derived	Li J, Xie P, Hu Y, Zhou Y, Zhao W, Xu X, Zhu D, Mi L, Xiang J, Cui M. Predictive Value of Combining Angio-Based Index of Microcirculatory Resistance and Fractional Flow Reserve in Patients with STEMI. Can J Cardiol. 2025 Jul;41(7):1363-1371. doi: 10.1016/j.cjca.2025.02.003. Epub 2025 Feb 6.

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases