Clinical trial NCT04628377: Prognostic Implication of Angiography-Derived IMR in STEMI Patients
Official title: Prognostic Implication of Angiography-Derived Index of Microcirculatory Resistance in Successfully Reperfused STEMI Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute ST-segment Elevation Myocardial Infarction
Keywords: STEMI
Index of microcirculatory resistance
Quantitative flow ratio
Fractional flow reserve
Prognosis
Angiography-derived IMR
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: RainMed Medical Group
First posted: 2020-11-13
Enrollment: 333
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: at the index procedure
measure: Cardiac death or heart failure admission
timeFrame: at 10 years from index procedure
Secondary outcomes:
measure: Any myocardial infarction
timeFrame: at 10 years from index procedure
measure: Ischemia-driven revascularization
timeFrame: at 10 years from index procedure
measure: Stent thrombosis
timeFrame: at 10 years from index procedure
measure: Congestive heart failure admission
timeFrame: at 10 years from index procedure
measure: Major adverse cardiac events
timeFrame: at 10 years from index procedure
measure: Cardiac death
timeFrame: at 10 years from index procedure
measure: All-cause death
timeFrame: at 10 years from index procedure
measure: Heart failure admission
timeFrame: at 10 years from index procedure
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center
name: Joo Myung Lee, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi KH, Dai N, Li Y, Kim J, Shin D, Lee SH, Joh HS, Kim HK, Jeon KH, Ha SJ, Kim SM, Jang MJ, Park TK, Yang JH, Song YB, Hahn JY, Doh JH, Shin ES, Choi SH, Gwon HC, Lee JM. Functional Coronary Angiography-Derived Index of Microcirculatory Resistance in Patients With ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Interv. 2021 Aug 9;14(15):1670-1684. doi: 10.1016/j.jcin.2021.05.027.