Prognostic Implication of Angiography-Derived IMR in STEMI Patients

NCT04628377 | Completed

• 1 other identifier: NCTSTEMI2575
• Study Type: observational
• Target: 333
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute ST-segment Elevation Myocardial Infarction

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy

  Diagnostic accuracy of angiography-derived IMR to predict invasive IMR

  at the index procedure

• Cardiac death or heart failure admission

  Cardiac death or heart failure admission

  at 10 years from index procedure

Secondary Outcomes (8)

• Any myocardial infarction

  at 10 years from index procedure

• Ischemia-driven revascularization

  at 10 years from index procedure

• Stent thrombosis

  at 10 years from index procedure

• Congestive heart failure admission

  at 10 years from index procedure

• Major adverse cardiac events

  at 10 years from index procedure

Study Arms (2)

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

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

Interventions

Angiography-drived Index of Microcirculatory Resistance DEVICE

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.

Also known as: Angiography-derived IMR

Diagnostic Accuracy Cohort; Prognosis Cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• RainMed Medical Group: collaborator

Related Publications (1)

• 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.

  PMID: 34353599 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Joo Myung Lee, MD, MPH, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professore

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: November 13, 2020
• Study Start: May 26, 2003
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04