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Coronary Artery DiseaseNCT06947564

AccuIMR Predicts Microvascular Obstruction and Infarct Size in STEMI Patients

An observational study of Coronary Artery Disease and STEMI - ST Elevation Myocardial Infarction, run by RenJi Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CMR
How many people
843 participants
Where
1 siteChina
Study dates
1 Jan 2012to 31 Dec 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • (1) STEMI patients who underwent PCI within 12 hours of symptom onset.
  • (2) coronary microvascular function was assessed using contrast-enhanced CMR after PCI.

Who cannot join

  • (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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Renji Hospital

    Shanghai, Shanghai Municipality, 200127

Other trials in China

About this study

Official title: 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.

Being tested
CMR
Keywords
AccuIMR, CMR, infarct size
Medical subject headings
Coronary Artery Disease, ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CMRDiagnostic test

    Coronary microvascular function was assessed using contrast-enhanced CMR after PCI.

Study groups in NCT06947564
Study groupRoleWhat they receive
STEMI patients underwent CMRSTEMI patients who underwent PCI within 12 hours of symptom onset.
Receives: Diagnostic Test: CMR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CMR

    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).

    Measured: CMR was performed at a median of 5 days post-reperfusion.

Secondary outcomes (2)
  1. LDL-C, mmol/L

    Low-density cholesterol (LDL-C) is the cholesterol in low-density lipoprotein (LDL), which reflects how much LDL is present.

    Measured: Blood samples were collected after a 12-hour fast in the second day post-PCI.

  2. HbA1c, %

    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.

    Measured: Blood samples were collected after a 12-hour fast in the second day post-PCI.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2025
  2. Study start1 Jan 2012
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2024

Resources

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
Retrospective
Enrolment
843 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06947564
Sponsor's protocol ID
Early MYO IMR-CMR
Status last verified
Apr 2025
First submitted
20 Apr 2025
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35078371
  • 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.

    PubMed 30660333
  • 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.

    PubMed 10637197
  • 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.

    PubMed 18237685
  • 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.

    PubMed 23681066
  • 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.

    PubMed 38375667
  • 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.

    PubMed 35636354
  • 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.

    PubMed 39115479
  • 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.

    PubMed 38660822
  • 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.

    PubMed 37284070
  • 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.

    PubMed 28823746
  • 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.

    PubMed 29680355
  • 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.

    PubMed 33530931
  • Sheng X, Hu Y, Zhang Y, Chen J, Xiang J, Ding S, Pu J. Angiography-Derived Index of Microcirculatory Resistance Predicts Microvascular Obstruction and Infarct Size in Patients With STEMI. JACC Asia. 2026 Jul 28:S2772-3747(26)00445-X. doi: 10.1016/j.jacasi.2026.06.013. Online ahead of print.

    PubMed 42541504

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and STEMI - ST Elevation Myocardial Infarction, run by RenJi Hospital at 1 site in China.

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 2 inclusion and 3 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 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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?

CMR (time frame: CMR was performed at a median of 5 days post-reperfusion.). 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 NCT06947564, which also lists 14 linked publications.

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 27 Apr 2025.

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