Skip to content

Prognostic Implication of Angiography-Derived IMR in STEMI Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04628377
Enrollment
333
Registered
2020-11-13
Start date
2003-05-26
Completion date
2023-04-01
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ST-segment Elevation Myocardial Infarction

Keywords

STEMI, Index of microcirculatory resistance, Quantitative flow ratio, Fractional flow reserve, Prognosis, Angiography-derived IMR

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.

Interventions

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.

Sponsors

RainMed Medical Group
CollaboratorINDUSTRY
Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracyat the index procedureDiagnostic accuracy of angiography-derived IMR to predict invasive IMR
Cardiac death or heart failure admissionat 10 years from index procedureCardiac death or heart failure admission

Secondary

MeasureTime frameDescription
All-cause deathat 10 years from index procedureAll-cause death
Heart failure admissionat 10 years from index procedureHeart failure admission
Any myocardial infarctionat 10 years from index procedureAny myocardial infarction
Major adverse cardiac eventsat 10 years from index procedurea composite of cardiac death, any myocardial infarction, ischemia-driven revascularization, definite or probable stent thrombosis, or congestive heart failure admission
Stent thrombosisat 10 years from index procedureDefinite or probable stent thrombosis according to ARC definition
Congestive heart failure admissionat 10 years from index procedureAdmission for congestive heart failure
Ischemia-driven revascularizationat 10 years from index procedureIschemia-driven revascularization
Cardiac deathat 10 years from index procedureCardiac death

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026