ST-segment Elevation Myocardial Infarction (STEMI)NCT04828681
Angio-IMR and Cardiac MR-derived MVO in STEMI Patients
An observational study of ST-segment Elevation Myocardial Infarction (STEMI), run by Samsung Medical Center at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI)
- What is being tested?
- Cardiac magnetic resonance imaging
- How many people
- 324 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Dec 2007to 31 Dec 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- STEMI patients
- Successful primary PCI in the culprit vessel
- Underwent cardiac MR during index hospitalization
- Suitable coronary angiographic images for angio-IMR analysis
Who cannot join
- patients with failed primary PCI
- treated by medical treatment alone without PCI
- no available coronary angiographic images
- insufficient image quality for angio-IMR calculation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Iowa Carver College of Medicine, Iowa City, IA, USA
Iowa City, Iowa
China1 site
Shanghai Institute of Cardiovascular Diseases, Shanghai, China
Shanghai, Shanghai Municipality
About this study
Official title: Functional Coronary Angiography-Derived Index of Microcirculatory Resistance and Microvascular Obstruction in Cardiac Magnetic Resonance Imaging After ST-segment Elevation Myocardial Infarction
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.
Read the 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).
- Being tested
- Cardiac magnetic resonance imaging
- Keywords
- ST-segment Elevation Myocardial Infarction (STEMI), Index of microcirculatory resistance, Cardiac magnetic resonance imaging, Microvascular obstruction, Coronary microcirculation
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic resonance imagingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Angio-IMR>40 Unit | Patients with angio-IMR>40U in the culprit vessel after successful primary PCI. Receives: 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. Receives: Diagnostic Test: Cardiac magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of microvascular obstruction in CMR
Proportion of microvascular obstruction in CMR
Measured: At the time of index hospitalization
Secondary outcomes (7)
Correlation of angio-IMR with the extent of microvascular obstruction in CMR
Correlation of angio-IMR with the extent of microvascular obstruction (% of left ventricular mass) in CMR
Measured: At the time of index hospitalization
Correlation of angio-IMR with the infarct size in CMR
Correlation of angio-IMR with the infarct size (% of left ventricular mass) in CMR
Measured: At the time of index hospitalization
Correlation of angio-IMR with the area at risk in CMR
Correlation of angio-IMR with the area at risk (% of left ventricular mass) in CMR
Measured: At the time of index hospitalization
Correlation of angio-IMR with the myocardial salvage index in CMR
Correlation of angio-IMR with the myocardial salvage index in CMR
Measured: At the time of index hospitalization
Discrimination ability of angio-IMR to predict the occurrence of microvascular obstruction in CMR
area under curve in ROC analysis of angio-IMR to predict the occurrence of microvascular obstruction in CMR
Measured: At the time of index hospitalization
Left ventricular ejection fraction
Left ventricular ejection fraction in echocardiography
Measured: At the time of index hospitalization and 1 year follow-up
Regional wall motion score index
Regional wall motion score index in echocardiography
Measured: At the time of index hospitalization and 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start24 Dec 2007
- Primary completion31 Dec 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 324 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- RainMed Medical Group, Shanghai Institute of Cardiovascular Diseases
- Responsible party
- Principal investigator, Joo Myung Lee, Samsung Medical Center
- Investigators
- Joo Myung Lee, MD, MPH, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828681
- Sponsor's protocol ID
- SMCCMR88848439
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2021
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be able to be shared upon reasonable request after discussion by steering committee members and principal investigator.
Publications
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.
PubMed 35249841
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Coronary Angiography-Derived Index of Microcirculatory Resistance and Microvascular Obstruction in Cardiac Magnetic Resonance Imaging After ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04828681
- Acronym / sponsor ID
- SMCCMR88848439
- Keywords
- ST-segment Elevation Myocardial Infarction (STEMI), Index of microcirculatory resistance, Cardiac magnetic resonance imaging, Microvascular obstruction, Coronary microcirculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- RainMed Medical Group, Shanghai Institute of Cardiovascular Diseases
- Study start
- 24 Dec 2007 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Angio-IMR>40 Unit | – | Diagnostic Test: Cardiac magnetic resonance imagingPatients with angio-IMR>40U in the culprit vessel after successful primary PCI. |
| Patients with Angio-IMR≤40 Unit | – | Diagnostic Test: Cardiac magnetic resonance imagingPatients with angio-IMR≤40U in the culprit vessel after successful primary PCI. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- STEMI patients
- Successful primary PCI in the culprit vessel
- Underwent cardiac MR during index hospitalization
- Suitable coronary angiographic images for angio-IMR analysis
Key exclusion criteria (4 listed)
- patients with failed primary PCI
- treated by medical treatment alone without PCI
- no available coronary angiographic images
- insufficient image quality for angio-IMR calculation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac magnetic resonance imagingCardiac 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. | Diagnostic test | Patients with Angio-IMR>40 Unit, Patients with Angio-IMR≤40 Unit |
Primary outcome
Proportion of microvascular obstruction in CMR
Time frame: At the time of index hospitalization
Proportion of microvascular obstruction in CMR
7 secondary outcomes
Correlation of angio-IMR with the extent of microvascular obstruction in CMR
Time frame: At the time of index hospitalization
Correlation of angio-IMR with the infarct size in CMR
Time frame: At the time of index hospitalization
Correlation of angio-IMR with the area at risk in CMR
Time frame: At the time of index hospitalization
Correlation of angio-IMR with the myocardial salvage index in CMR
Time frame: At the time of index hospitalization
Discrimination ability of angio-IMR to predict the occurrence of microvascular obstruction in CMR
Time frame: At the time of index hospitalization
Left ventricular ejection fraction
Time frame: At the time of index hospitalization and 1 year follow-up
Regional wall motion score index
Time frame: At the time of index hospitalization and 1 year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Derived from this study: PubMed 35249841Shin 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.
- Individual participant dataSharing planned: Undecided. IPD will be able to be shared upon reasonable request after discussion by steering committee members and principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo Myung Lee, MD, MPH, PhD principal investigator
Samsung Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST-segment Elevation Myocardial Infarction (STEMI), run by Samsung Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of microvascular obstruction in CMR (time frame: At the time of index hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04828681, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.