Clinical trial NCT04828681: Angio-IMR and Cardiac MR-derived MVO in STEMI Patients
Official title: Functional Coronary Angiography-Derived Index of Microcirculatory Resistance and Microvascular Obstruction in Cardiac Magnetic Resonance Imaging After ST-segment Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: RainMed Medical Group
name: Shanghai Institute of Cardiovascular Diseases
First posted: 2021-04-02
Enrollment: 324
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Detailed description: 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.

The study population will be derived from the prospective institutional AMI registry of Samsung Medical Center between December 2007 and July 2014. Main results from this registry were published elsewhere (PLoS One. 2017 Jan 12;12(1):e0170115 and Sci Rep. 2019 Jul 4;9(1):9646). In this registry, 515 consecutive patients who presented with acute myocardial infarction and underwent CMR were prospectively enrolled. AMI was defined as evidence of myocardial injury (defined as elevation of cardiac troponin values, with at least one value above the 99th percentile upper reference limit) with necrosis in a clinical setting, consistent with myocardial ischemia. Among the total patients, STEMI patients (n = 332), whose electrocardiogram showed ST-segment elevation more than 1 mm in two or more contiguous leads or a presumably new-onset left bundle branch block, 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, functional coronary angiography core laboratory (Shanghai Institute of Cardiovascular Diseases, Shanghai, China) evaluated the quality of angiographic images and additionally exclude patients with insufficient image quality for angio-IMR calculation (n=37). All patients also underwent baseline and 1-year follow-up echocardiography. The Institutional Review Board of Samsung Medical Center approved this study, and all patients provided written informed consent.

The association of Angio-IMR with CMR-derived quantitative parameters (extent of MVO, infarct size, area at risk) and qualitative parameter (presence of MVO) will be analyzed. The discrimination ability of angio-IMR to predict the presence of MVO in CMR will be compared with conventional angiographic measures of culprit vessel reperfusion (TIMI flow grade, myocardial blush grade).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of microvascular obstruction in CMR
timeFrame: At the time of index hospitalization
Secondary outcomes:
measure: Correlation of angio-IMR with the extent of microvascular obstruction in CMR
timeFrame: At the time of index hospitalization
measure: Correlation of angio-IMR with the infarct size in CMR
timeFrame: At the time of index hospitalization
measure: Correlation of angio-IMR with the area at risk in CMR
timeFrame: At the time of index hospitalization
measure: Correlation of angio-IMR with the myocardial salvage index in CMR
timeFrame: At the time of index hospitalization
measure: Discrimination ability of angio-IMR to predict the occurrence of microvascular obstruction in CMR
timeFrame: At the time of index hospitalization
measure: Left ventricular ejection fraction
timeFrame: At the time of index hospitalization and 1 year follow-up
measure: Regional wall motion score index
timeFrame: At the time of index hospitalization and 1 year follow-up
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Carver College of Medicine, Iowa City, IA, USA
state: Iowa
city: Shanghai
country: China
facility: Shanghai Institute of Cardiovascular Diseases, Shanghai, China
state: Shanghai
Study officials:
affiliation: Samsung Medical Center
name: Joo Myung Lee, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.