- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06947564
AccuIMR Predicts Microvascular Obstruction and Infarct Size in STEMI Patients
April 20, 2025 updated by: RenJi Hospital
Angiography-derived Index of Microcirculatory Resistance Predicts Microvascular Obstruction and Infarct Size in Patients With ST-segment-elevation Myocardial Infarction
In this study, we aimed to investigate the clinical significance of the angiography-based IMR calculation method (AccuIMR) and its prognostic assessment capability by evaluating the concordance or discordance between AccuIMR values and cardiac magnetic resonance (CMR) results.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
843
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200127
- RenJi Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
STEMI patients who underwent PCI within 12 hours of symptom onset, and coronary microvascular function was assessed using contrast-enhanced CMR after PCI.
Description
Inclusion Criteria:
- (1) STEMI patients who underwent PCI within 12 hours of symptom onset.
- (2) coronary microvascular function was assessed using contrast-enhanced CMR after PCI.
Exclusion Criteria:
- (1) Suboptimal coronary angiographic images, including inadequate contrast opacification, unsatisfactory projection view, and severe overlap or distortion of the target vessel.
- (2) Lacking two angiographic projections separated by at least 25° apart post-PCI.
- (3) Inadequate CMR image quality
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
STEMI patients underwent CMR
STEMI patients who underwent PCI within 12 hours of symptom onset.
|
Coronary microvascular function was assessed using contrast-enhanced CMR after PCI.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CMR
Time Frame: CMR was performed at a median of 5 days post-reperfusion.
|
Contrast-enhanced CMR was performed on a 3.0-T scanner (Achieva TX, Philips Healthcare, Best, The Netherlands) .
All sequences were acquired during breath-hold with a field of view at 350 × 350 mm2.
Two experienced readers, blinded to clinical data, evaluated the CMR results using validated software (QMass MR 7.5, Medis, Leiden, The Netherlands).
The acquired images were utilized to assess ventricular parameters and calculate the left ventricular ejection fraction (LVEF).
|
CMR was performed at a median of 5 days post-reperfusion.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
LDL-C, mmol/L
Time Frame: Blood samples were collected after a 12-hour fast in the second day post-PCI.
|
Low-density cholesterol (LDL-C) is the cholesterol in low-density lipoprotein (LDL), which reflects how much LDL is present.
|
Blood samples were collected after a 12-hour fast in the second day post-PCI.
|
|
HbA1c, %
Time Frame: Blood samples were collected after a 12-hour fast in the second day post-PCI.
|
Hemoglobin a1c (HbA1c) is the combination of hemoglobin and blood sugar.
Its concentration in the blood is stable and is not affected by short-term blood sugar concentrations.
Hemoglobin A1C has obvious clinical value in the diagnosis of diabetes.
|
Blood samples were collected after a 12-hour fast in the second day post-PCI.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jun Pu, MD, PhD, RenJi Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gibson CM, Cannon CP, Murphy SA, Ryan KA, Mesley R, Marble SJ, McCabe CH, Van De Werf F, Braunwald E. Relationship of TIMI myocardial perfusion grade to mortality after administration of thrombolytic drugs. Circulation. 2000 Jan 18;101(2):125-30. doi: 10.1161/01.cir.101.2.125.
- Fearon WF, Shah M, Ng M, Brinton T, Wilson A, Tremmel JA, Schnittger I, Lee DP, Vagelos RH, Fitzgerald PJ, Yock PG, Yeung AC. Predictive value of the index of microcirculatory resistance in patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2008 Feb 5;51(5):560-5. doi: 10.1016/j.jacc.2007.08.062.
- Fearon WF, Low AF, Yong AS, McGeoch R, Berry C, Shah MG, Ho MY, Kim HS, Loh JP, Oldroyd KG. Prognostic value of the Index of Microcirculatory Resistance measured after primary percutaneous coronary intervention. Circulation. 2013 Jun 18;127(24):2436-41. doi: 10.1161/CIRCULATIONAHA.112.000298. Epub 2013 May 16.
- Symons R, Pontone G, Schwitter J, Francone M, Iglesias JF, Barison A, Zalewski J, de Luca L, Degrauwe S, Claus P, Guglielmo M, Nessler J, Carbone I, Ferro G, Durak M, Magistrelli P, Lo Presti A, Aquaro GD, Eeckhout E, Roguelov C, Andreini D, Vogt P, Guaricci AI, Mushtaq S, Lorenzoni V, Muller O, Desmet W, Agati L, Janssens S, Bogaert J, Masci PG. Long-Term Incremental Prognostic Value of Cardiovascular Magnetic Resonance After ST-Segment Elevation Myocardial Infarction: A Study of the Collaborative Registry on CMR in STEMI. JACC Cardiovasc Imaging. 2018 Jun;11(6):813-825. doi: 10.1016/j.jcmg.2017.05.023. Epub 2017 Aug 16.
- De Maria GL, Alkhalil M, Wolfrum M, Fahrni G, Borlotti A, Gaughran L, Dawkins S, Langrish JP, Lucking AJ, Choudhury RP, Porto I, Crea F, Dall'Armellina E, Channon KM, Kharbanda RK, Banning AP. Index of Microcirculatory Resistance as a Tool to Characterize Microvascular Obstruction and to Predict Infarct Size Regression in Patients With STEMI Undergoing Primary PCI. JACC Cardiovasc Imaging. 2019 May;12(5):837-848. doi: 10.1016/j.jcmg.2018.02.018. Epub 2018 Apr 18.
- Jiang J, Li C, Hu Y, Li C, He J, Leng X, Xiang J, Ge J, Wang J. A novel CFD-based computed index of microcirculatory resistance (IMR) derived from coronary angiography to assess coronary microcirculation. Comput Methods Programs Biomed. 2022 Jun;221:106897. doi: 10.1016/j.cmpb.2022.106897. Epub 2022 May 18.
- Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26. Erratum In: Circulation. 2022 Sep 6;146(10):e141. doi: 10.1161/CIR.0000000000001074.
- Frampton J, Devries JT, Welch TD, Gersh BJ. Modern Management of ST-Segment Elevation Myocardial Infarction. Curr Probl Cardiol. 2020 Mar;45(3):100393. doi: 10.1016/j.cpcardiol.2018.08.005. Epub 2018 Sep 14.
- Scarsini R, Kotronias RA, Della Mora F, Portolan L, Andreaggi S, Benenati S, Marin F, Sgreva S, Comuzzi A, Butturini C, Pesarini G, Tavella D, Channon KM, Garcia Garcia HM, Ribichini F, Banning AP, De Maria GL. Angiography-Derived Index of Microcirculatory Resistance to Define the Risk of Early Discharge in STEMI. Circ Cardiovasc Interv. 2024 Mar;17(3):e013556. doi: 10.1161/CIRCINTERVENTIONS.123.013556. Epub 2024 Feb 20.
- Zhang Y, Pu J, Niu T, Fang J, Chen D, Yidilisi A, Zheng Y, Lu J, Hu Y, Koo BK, Xiang J, Wang J, Jiang J. Prognostic Value of Coronary Angiography-Derived Index of Microcirculatory Resistance in Non-ST-Segment Elevation Myocardial Infarction Patients. JACC Cardiovasc Interv. 2024 Aug 26;17(16):1874-1886. doi: 10.1016/j.jcin.2024.04.048. Epub 2024 Aug 7.
- Yidilisi A, Chen D, Zhang Y, Pu J, Niu T, Hu Y, Fang J, Gong Q, Zheng Y, Huang J, Xiang J, Wang Y, Wang J, Jiang J. Coronary Angiography-Derived Index of Microcirculatory Resistance Predicts Outcome in Patients With ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2024 May;17(5):e013899. doi: 10.1161/CIRCINTERVENTIONS.123.013899. Epub 2024 Apr 25. No abstract available.
- Fan Y, Li C, Hu Y, Hu X, Wang S, He J, Leng X, Xiang J, Lu Z. Angiography-based index of microcirculatory resistance (AccuIMR) for the assessment of microvascular dysfunction in acute coronary syndrome and chronic coronary syndrome. Quant Imaging Med Surg. 2023 Jun 1;13(6):3556-3568. doi: 10.21037/qims-22-961. Epub 2023 Apr 17.
- Qi Y, Gu R, Xu J, Kang L, Liu Y, Wang L, Chen J, Zhang J, Wang K. Index of microcirculatory resistance predicts long term cardiac systolic function in patients with STEMI undergoing primary PCI. BMC Cardiovasc Disord. 2021 Feb 2;21(1):66. doi: 10.1186/s12872-021-01887-w.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2012
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
April 20, 2025
First Submitted That Met QC Criteria
April 20, 2025
First Posted (Actual)
April 27, 2025
Study Record Updates
Last Update Posted (Actual)
April 27, 2025
Last Update Submitted That Met QC Criteria
April 20, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Early MYO IMR-CMR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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