Prognostic Implication of Angiography-Derived IMR in STEMI Patients

April 10, 2023 updated by: Joo Myung Lee, Samsung Medical Center

Prognostic Implication of Angiography-Derived Index of Microcirculatory Resistance in Successfully Reperfused STEMI Patients

Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of STEMI patients. Previous study presented that index of microcirculatory resistance (IMR) in culprit vessel of STEMI patients showed significant association with the risk of cardiac death or heart failure admission. Recent technical development enabled angiographic derivation of IMR without pressure wire, hyperemic agents, or theromdilution method. In this regard, the current study will evaluate prognostic implication of angiography-derived IMR in STEMI patients who were successfully revascularized.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of STEMI patients. Previous study presented that index of microcirculatory resistance (IMR) in culprit vessel of STEMI patients showed significant association with the risk of cardiac death or heart failure admission. Recent technical development enabled angiographic derivation of IMR without pressure wire, hyperemic agents, or theromdilution method. In this regard, the current study will evaluate prognostic implication of angiography-derived IMR in STEMI patients who were successfully revascularized.

The study cohorts consist with 2 separate cohort: first, diagnostic accuracy cohort, which will evaluate diagnostic accuracy of angiography-derived IMR for invasive IMR. For this, 31 patients with culprit vessel IMR measurement at the time of primary PCI will be evaluated. The patients cohort is the subgroup of previous registry (NCT02186093). Second, prognosis cohort, in which angiography-derived IMR will be measured in the culprit vessel after successful revascularization. Those patients have follow-up data after 10 years from index procedure. This cohort is STEMI subgroup derived from Institutional registry of Samsung Medical Center, whose results were previously published (JACC Cardiovascular Intervention. 2019 Apr 8;12(7):607-620.) Among 490 STEMI patients from the overall study cohorts, 309 patients with available angiograms and who were suitable for angiographic FFR and IMR measurement will be analyzed. Primary clinical outcome will be cardiac death at 10 years from index procedure. Secondary outcome will be any myocardial infarction, ischemia-driven revascularization, definite or probable stent thrombosis, congestive heart failure admission at 10 years from index procedure.

Study Type

Observational

Enrollment (Actual)

333

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Diagnostic Accuracy Cohort 31 STEMI patients who underwent IMR measurement in culprit vessel.

Prognosis Cohort 309 patients with available angiograms and who were suitable for angiographic FFR and IMR measurement and have 10 years follow-up data.

Description

Inclusion Criteria:

  • STEMI patients who were successfully revascularized for culprit vessel
  • analyzable angiograms at the index procedure

Exclusion Criteria:

  • Previous coronary artery bypass grafting
  • Coronary bypass graft as culprit vessel
  • Patients with unclear culprit vessel
  • limited image quality of coronary angiography
  • Insufficient angiographic project for TIMI frame count
  • Severe tortuosity of culprit vessel
  • No optimal projection for reconstruction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diagnostic Accuracy Cohort
Patients are subgroup of previously published study (JACC Cardiovascular Intervention 2020;13:1155-67), which evaluated invasive physiologic indices from culprit and non-culprit vessels of acute myocardial infarction patients. From the study cohort, 31 STEMI patients who underwent IMR measurement in culprit vessel after successful revascularization will be analyzed. In these patients, diagnostic accuracy of angiography-derived IMR will be compared with invasive IMR.
Device: Angiography-drived Index of Microcirculatory Resistance

From coronary angiographic images, angiography-derived IMR will be calculated based on mathematical calculation.

Angiography-derived IMR = (hyperemic Pa x angiography-derived FFR) x (vessel length / {K x V diastole}).

Hyperemic Pa will be estimated from resting Pa according to prespecified equation.

Other Names:
  • Angiography-derived IMR
Prognosis Cohort
Prognosis cohort, in which angiography-derived IMR will be measured in the culprit vessel after successful revascularization. Those patients have follow-up data after 10 years from index procedure. This cohort is STEMI subgroup derived from Institutional registry of Samsung Medical Center, whose results were previously published (JACC Cardiovascular Intervention. 2019 Apr 8;12(7):607-620.) Among 490 STEMI patients from the overall study cohorts, 309 patients with available angiograms and who were suitable for angiographic FFR and IMR measurement will be analyzed. Primary clinical outcome will be cardiac death at 10 years from index procedure. Secondary outcome will be any myocardial infarction, ischemia-driven revascularization, definite or probable stent thrombosis, congestive heart failure admission at 10 years from index procedure.
Device: Angiography-drived Index of Microcirculatory Resistance

From coronary angiographic images, angiography-derived IMR will be calculated based on mathematical calculation.

Angiography-derived IMR = (hyperemic Pa x angiography-derived FFR) x (vessel length / {K x V diastole}).

Hyperemic Pa will be estimated from resting Pa according to prespecified equation.

Other Names:
  • Angiography-derived IMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy
Time Frame: at the index procedure
Diagnostic accuracy of angiography-derived IMR to predict invasive IMR
at the index procedure
Cardiac death or heart failure admission
Time Frame: at 10 years from index procedure
Cardiac death or heart failure admission
at 10 years from index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any myocardial infarction
Time Frame: at 10 years from index procedure
Any myocardial infarction
at 10 years from index procedure
Ischemia-driven revascularization
Time Frame: at 10 years from index procedure
Ischemia-driven revascularization
at 10 years from index procedure
Stent thrombosis
Time Frame: at 10 years from index procedure
Definite or probable stent thrombosis according to ARC definition
at 10 years from index procedure
Congestive heart failure admission
Time Frame: at 10 years from index procedure
Admission for congestive heart failure
at 10 years from index procedure
Major adverse cardiac events
Time Frame: at 10 years from index procedure
a composite of cardiac death, any myocardial infarction, ischemia-driven revascularization, definite or probable stent thrombosis, or congestive heart failure admission
at 10 years from index procedure
Cardiac death
Time Frame: at 10 years from index procedure
Cardiac death
at 10 years from index procedure
All-cause death
Time Frame: at 10 years from index procedure
All-cause death
at 10 years from index procedure
Heart failure admission
Time Frame: at 10 years from index procedure
Heart failure admission
at 10 years from index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

RainMed Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2003

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

November 8, 2020

First Submitted That Met QC Criteria

November 12, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCTSTEMI2575

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Anonymized study data can be shared upon reasonable proposition. Principle investigator will review the request and decide whether the study data will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe