NCT05696379

Brief Summary

Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of acute myocardial infarction (AMI) patients, and has been shown to be associated with poor prognosis. Angiography derived index of micro-circulatory resistance (Angio-IMR) is a novel pressure-wire free approach to assess coronary microvascular disease with great diagnostic performance. The current study will further investigate the prognostic value of Angio-IMR in patients with AMI in multicenter retrospective cohort.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

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

June 1, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
Last Updated

January 25, 2023

Status Verified

December 1, 2022

Enrollment Period

5 years

First QC Date

December 13, 2022

Last Update Submit

January 13, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Cardiac death or readmission for heart failure in 1 month

    Incidence of cardiac death or readmission for heart failure during first 1 month follow-up.

    1 month

  • Cardiac death or readmission for heart failure in 6 months

    Incidence of cardiac death or readmission for heart failure during first 6 months follow-up.

    6 month

  • Cardiac death or readmission for heart failure in 1 year

    Incidence of cardiac death or readmission for heart failure during first 1 year follow-up.

    1 year

  • Cardiac death or readmission for heart failure in 2 years

    Incidence of cardiac death or readmission for heart failure during first 2 years follow-up.

    2 year

Study Arms (4)

STEMI with high Angio-IMR

Patients with ST segment elevation myocardial infarction and high Angio-IMR

Other: Angiography derived index of micro-circulatory resistance (Angio-IMR)

STEMI with low Angio-IMR

Patients with ST segment elevation myocardial infarction and low Angio-IMR

Other: Angiography derived index of micro-circulatory resistance (Angio-IMR)

NSTEMI with high Angio-IMR

Patients with non-ST segment elevation myocardial infarction and high Angio-IMR

Other: Angiography derived index of micro-circulatory resistance (Angio-IMR)

NSTEMI with low Angio-IMR

Patients with non-ST segment elevation myocardial infarction and low Angio-IMR

Other: Angiography derived index of micro-circulatory resistance (Angio-IMR)

Interventions

Angiography derived index of micro-circulatory resistance (Angio-IMR) post percutaneous coronary intervention.

NSTEMI with high Angio-IMRNSTEMI with low Angio-IMRSTEMI with high Angio-IMRSTEMI with low Angio-IMR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted with a diagnosis of acute myocardial infarction underwent successful percutaneous coronary intervention.

You may qualify if:

  • Acute myocardial infarction patients who underwent successful percutaneous coronary intervention

You may not qualify if:

  • No appropriate coronary angiography images (inferior image quality, image loss, severe arteries overlap, or significant artifact)
  • Previous coronary artery bypass graft

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (3)

  • Chen Z, Zhang Y, Fang J, Zheng Y, Chen D, Yidilisi A, Zhang X, Liu C, Huang J, Ji R, Chen J, Chen G, Lin P, Hu Y, Xiang J, Wang J, Jiang J. Thorough Physiological Assessment in Non-Culprit Vessels of Patients with Acute Myocardial Infarction: Is It a Required Action? Cardiovasc Drugs Ther. 2025 Sep 6. doi: 10.1007/s10557-025-07768-0. Online ahead of print.

  • Chen D, Zhang Y, Yidilisi A, Hu D, Zheng Y, Fang J, Gong Q, Huang J, Dong Q, Pu J, Niu T, Xiang J, Wang J, Jiang J. Combined risk estimates of diabetes and coronary angiography-derived index of microcirculatory resistance in patients with non-ST elevation myocardial infarction. Cardiovasc Diabetol. 2024 Aug 16;23(1):300. doi: 10.1186/s12933-024-02400-1.

  • Zhang Y, Pu J, Niu T, Fang J, Chen D, Yidilisi A, Zheng Y, Lu J, Hu Y, Koo BK, Xiang J, Wang J, Jiang J. Prognostic Value of Coronary Angiography-Derived Index of Microcirculatory Resistance in Non-ST-Segment Elevation Myocardial Infarction Patients. JACC Cardiovasc Interv. 2024 Aug 26;17(16):1874-1886. doi: 10.1016/j.jcin.2024.04.048. Epub 2024 Aug 7.

Study Design

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

Study Record Dates

First Submitted

December 13, 2022

First Posted

January 25, 2023

Study Start

June 1, 2017

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

January 25, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations