Prognostic Implication of Angiography-Derived IMR in STEMI Patients

Acute ST-segment Elevation Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04628377
• Other study ID #: NCTSTEMI2575
• Status: Completed
• Start date: May 26, 2003
• Est. completion date: April 1, 2023

Study information

• Verified date: April 2023
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: April 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute ST-segment Elevation Myocardial Infarction
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	RainMed Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	Diagnostic accuracy of angiography-derived IMR to predict invasive IMR	at the index procedure
Primary	Cardiac death or heart failure admission	Cardiac death or heart failure admission	at 10 years from index procedure
Secondary	Any myocardial infarction	Any myocardial infarction	at 10 years from index procedure
Secondary	Ischemia-driven revascularization	Ischemia-driven revascularization	at 10 years from index procedure
Secondary	Stent thrombosis	Definite or probable stent thrombosis according to ARC definition	at 10 years from index procedure
Secondary	Congestive heart failure admission	Admission for congestive heart failure	at 10 years from index procedure
Secondary	Major adverse cardiac events	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
Secondary	Cardiac death	Cardiac death	at 10 years from index procedure
Secondary	All-cause death	All-cause death	at 10 years from index procedure
Secondary	Heart failure admission	Heart failure admission	at 10 years from index procedure