Angio-IMR and Cardiac MR-derived MVO in STEMI Patients

NCT04828681 | Completed DMC

• 1 other identifier: SMCCMR88848439
• Study Type: observational
• Target: 324
• Locations: 2 countries
• Sites: 2

Brief Summary

Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of ST-segment elevation myocardial infarction (STEMI) patients. Microvascular obstruction (MVO) in cardiac magnetic resonance (CMR) is significant prognostic indicator in STEMI patients after primary percutaneous coronary intervention (PCI). Although current gold-standard method to assess microvascular damage or dysfunction in STEMI patients is CMR and assessment of MVO, previous study presented that index of microcirculatory resistance (IMR) in culprit vessel of STEMI patients showed significant association with the presence of MVO in CMR and the risk of cardiac death or heart failure admission. Nevertheless, the need for pressure-temperature sensor wire and hyperemic agents significantly limits adoption of IMR in daily practice. Recent technical development enabled angiographic derivation of IMR without pressure wire, hyperemic agents, or thermodilution method. In this regard, the current study will evaluate the feasibility of functional angiography-derived IMR (angio-IMR) in the evaluation of MVO after successful primary PCI for STEMI.

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)

Keywords

ST-segment Elevation Myocardial Infarction (STEMI); Index of microcirculatory resistance; Cardiac magnetic resonance imaging; Microvascular obstruction; Coronary microcirculation

Outcome Measures

Primary Outcomes (1)

• Proportion of microvascular obstruction in CMR

  Proportion of microvascular obstruction in CMR

  At the time of index hospitalization

Secondary Outcomes (7)

• Correlation of angio-IMR with the extent of microvascular obstruction in CMR

  At the time of index hospitalization

• Correlation of angio-IMR with the infarct size in CMR

  At the time of index hospitalization

• Correlation of angio-IMR with the area at risk in CMR

  At the time of index hospitalization

• Correlation of angio-IMR with the myocardial salvage index in CMR

  At the time of index hospitalization

• Discrimination ability of angio-IMR to predict the occurrence of microvascular obstruction in CMR

  At the time of index hospitalization

Study Arms (2)

Patients with Angio-IMR>40 Unit

Patients with angio-IMR\>40U in the culprit vessel after successful primary PCI.

Diagnostic Test: Cardiac magnetic resonance imaging

Patients with Angio-IMR≤40 Unit

Patients with angio-IMR≤40U in the culprit vessel after successful primary PCI.

Diagnostic Test: Cardiac magnetic resonance imaging

Interventions

Cardiac magnetic resonance imaging DIAGNOSTIC_TEST

Cardiac magnetic resonance imaging was performed 5.0 ± 5.8 days after the primary PCI. MVO, infarct size, and myocardial salvage index were quantitatively assessed in CMR.

Patients with Angio-IMR>40 Unit; Patients with Angio-IMR≤40 Unit

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be derived from the prospective institutional AMI registry of Samsung Medical Center between December 2007 and July 2014. In this registry, 515 consecutive patients who presented with acute myocardial infarction and underwent CMR were prospectively enrolled. Among the total patients, STEMI patients (n = 332) will be analyzed for the current study. For the study purpose, patients with failed primary PCI (n=1), treated by medical treatment alone without PCI (n=4), and no available coronary angiographic images (n=3) will be excluded. Among the remaining 324 patients, patients with insufficient image quality for angio-IMR calculation will be additionally excluded (n=37).

You may qualify if:

• STEMI patients
• Successful primary PCI in the culprit vessel
• Underwent cardiac MR during index hospitalization
• Suitable coronary angiographic images for angio-IMR analysis

You may not qualify if:

• patients with failed primary PCI
• treated by medical treatment alone without PCI
• no available coronary angiographic images
• insufficient image quality for angio-IMR calculation

Sponsors & Collaborators

• Samsung Medical Center: lead
• RainMed Medical Group: collaborator
• Shanghai Institute of Cardiovascular Diseases: collaborator

Study Sites (2)

University of Iowa Carver College of Medicine, Iowa City, IA, USA

Iowa City, Iowa, United States

Location

Shanghai Institute of Cardiovascular Diseases, Shanghai, China

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

• Shin D, Kim J, Choi KH, Dai N, Li Y, Lee SH, Joh HS, Kim HK, Kim SM, Ha SJ, Jang MJ, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Choe YH, Gwon HC, Lee JM. Functional angiography-derived index of microcirculatory resistance validated with microvascular obstruction in cardiac magnetic resonance after STEMI. Rev Esp Cardiol (Engl Ed). 2022 Oct;75(10):786-796. doi: 10.1016/j.rec.2022.01.004. Epub 2022 Mar 3. English, Spanish.

  PMID: 35249841 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: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 2, 2021
• Study Start: December 24, 2007
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

US (1); CN (1)