Multimodality Assessment of Myocardial Reperfusion After Primary Percutaneous Coronary Intervention

NCT07876791 | Not Yet Recruiting

• 1 other identifier: AUH-MD-PCI-AI-2026-01
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate myocardial reperfusion in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Although primary PCI successfully restores blood flow in the blocked coronary artery, some patients continue to have impaired blood flow within the small vessels of the heart muscle, a condition known as microvascular obstruction (MVO). This complication may be associated with greater myocardial injury and poorer clinical outcomes. The study will investigate whether artificial intelligence (AI)-derived electrocardiographic (ECG) features, coronary angiographic parameters, and cardiac magnetic resonance (CMR) findings can provide complementary information about myocardial reperfusion. Patients undergoing primary PCI will be assessed using ECG and angiographic findings, while CMR will be used to evaluate myocardial injury and microvascular obstruction. The main objective is to determine whether combining AI-derived ECG features and angiographic parameters can improve the prediction of CMR-detected microvascular obstruction after primary PCI. The findings may help identify patients at increased risk of impaired myocardial reperfusion and support future risk assessment strategies following STEMI.

Conditions

ST Elevation (STEMI) Myocardial Infarction; Microvascular Obstruction (MVO)

Keywords

Primary Percutaneous Coronary intervention; ST-Elevation Myocardial Ifarction; Microvascular Obstruction; Cardiac Magnetic Resonance; Artificial Intelligence; Electrocardiography; Myocardial Reperfusion

Outcome Measures

Primary Outcomes (1)

• Incidence of Cardiac MRI-Detected Microvascular Obstruction After Primary PCI

  The proportion of patients with microvascular obstruction (MVO) detected by contrast-enhanced cardiac magnetic resonance (CMR) following primary PCI. MVO will be identified as a hypointense region within the hyperenhanced infarcted myocardium on late gadolinium enhancement images. The primary outcome will be reported as the number and percentage of patients with MVO.

  Use the actual CMR acquisition window specified in your protocol. For example, if CMR is scheduled 3-7 days after PCI: Within 3-7 Days After Primary PCI [Copy] The 3-7-day window is an example, not a confirmed detail from your protocol.

Secondary Outcomes (4)

• Predictive performance of combined model

  7 days

• Infarct Size

  7 days

• Left Ventricular ejection fraction

  7 days

• intramyocardial hemorrhage

  7 days

Study Arms (1)

STEMI Patients undergoing Primary PCI

This cohort will include adult patients presenting with ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI). Participants will undergo assessment of conventional and artificial intelligence (AI)-derived electrocardiographic features, coronary angiographic parameters, and cardiac magnetic resonance (CMR) findings to evaluate myocardial reperfusion. Angiographic assessment will include parameters such as TIMI flow grade, myocardial blush grade, and corrected TIMI frame count. CMR will be used to assess myocardial injury and the presence and extent of microvascular obstruction (MVO). The study will investigate the association between ECG and angiographic parameters and CMR-detected MVO. All participants will belong to a single observational cohort, with subsequent comparisons according to the presence or absence of MVO. No experimental treatment allocation will be performed, and clinical management will follow standard insti

Eligibility Criteria

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

Study Population

Consecutive adult patients presenting with a first STEMI and treated with primary PCI will be screened. The primary analysis cohort will include patients with technically successful primary PCI, analyzable pre- and post-reperfusion ECGs, interpretable angiographic reperfusion assessment and diagnostic early CMR.

You may qualify if:

• Age ≥18 years.
• First acute STEMI diagnosed according to contemporary guideline criteria and selected for a primary PCI strategy.
• Identifiable infarct-related coronary artery treated by primary PCI.
• Successful restoration of epicardial coronary flow, preferably final TIMI grade 3 flow for the primary mechanistic cohort.
• Technically adequate 12-lead ECG before reperfusion and standardized post-reperfusion ECG.
• Angiograms of adequate quality for TIMI flow, MBG and cTFC assessment.
• Ability to undergo contrast-enhanced CMR during the index admission.

You may not qualify if:

• Previous myocardial infarction with established scar likely to confound CMR infarct characterization or ECG interpretation.
• Previous CABG.
• Known cardiomyopathy or pre-existing significant LV systolic dysfunction unrelated to the index STEMI.
• Significant primary valvular heart disease.
• Ventricular paced rhythm or other ECG condition that prevents reliable prespecified ECG analysis, according to the requirements of the AI platform.
• Persistent severe hemodynamic instability or other clinical condition preventing safe CMR.
• Contraindication to MRI or gadolinium contrast according to institutional CMR policy.
• Non-diagnostic CMR for the primary endpoint.
• Poor-quality angiography precluding core reperfusion measurements.
• Refusal or inability to provide informed consent.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (12)

• van 't Hof AW, Liem A, Suryapranata H, Hoorntje JC, de Boer MJ, Zijlstra F. Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade. Zwolle Myocardial Infarction Study Group. Circulation. 1998 Jun 16;97(23):2302-6. doi: 10.1161/01.cir.97.23.2302.

  PMID: 9639373 BACKGROUND

• Gibson CM, Cannon CP, Daley WL, Dodge JT Jr, Alexander B Jr, Marble SJ, McCabe CH, Raymond L, Fortin T, Poole WK, Braunwald E. TIMI frame count: a quantitative method of assessing coronary artery flow. Circulation. 1996 Mar 1;93(5):879-88. doi: 10.1161/01.cir.93.5.879.

  PMID: 8598078 BACKGROUND

• Schulz-Menger J, Bluemke DA, Bremerich J, Flamm SD, Fogel MA, Friedrich MG, Kim RJ, von Knobelsdorff-Brenkenhoff F, Kramer CM, Pennell DJ, Plein S, Nagel E. Standardized image interpretation and post-processing in cardiovascular magnetic resonance - 2020 update : Society for Cardiovascular Magnetic Resonance (SCMR): Board of Trustees Task Force on Standardized Post-Processing. J Cardiovasc Magn Reson. 2020 Mar 12;22(1):19. doi: 10.1186/s12968-020-00610-6.

  PMID: 32160925 BACKGROUND

• Kramer CM, Barkhausen J, Bucciarelli-Ducci C, Flamm SD, Kim RJ, Nagel E. Standardized cardiovascular magnetic resonance imaging (CMR) protocols: 2020 update. J Cardiovasc Magn Reson. 2020 Feb 24;22(1):17. doi: 10.1186/s12968-020-00607-1.

  PMID: 32089132 BACKGROUND

• Pollio Benvenuto C, Galante D, Zimmermann F, Vicere A, Viccaro V, Giuliana C, Todisco S, Bellamoli M, Bettari L, Maffeo D, Burzotta F, Leone AM, Buono A. Angiography-Derived Index of Microvascular Resistance in Patients With Anterior ST-Segment Elevation Myocardial Infarction After Successful Primary Percutaneous Coronary Intervention. Am J Cardiol. 2026 Mar 15;263:1-6. doi: 10.1016/j.amjcard.2025.11.023. Epub 2025 Dec 31.

  PMID: 41482053 BACKGROUND

• Wang L, Travieso A, van der Hoeven N, Lombardi M, van Leeuwen MAH, Janssens G, Shabbir A, Mejia-Renteria H, Milasinovic D, Gonzalo N, Nijveldt R, van Royen N, Escaned J. Angiography-versus wire-based microvascular resistance index to detect coronary microvascular obstruction associated with ST-segment elevation myocardial infarction. Int J Cardiol. 2024 Sep 15;411:132256. doi: 10.1016/j.ijcard.2024.132256. Epub 2024 Jun 10.

  PMID: 38866108 BACKGROUND

• Wen X, Wang Z, Zheng B, Gong Y, Huo Y. Ability of the coronary angiography-derived index of microcirculatory resistance to predict microvascular obstruction in patients with ST-segment elevation. Front Cardiovasc Med. 2024 Apr 22;11:1187599. doi: 10.3389/fcvm.2024.1187599. eCollection 2024.

  PMID: 38711790 BACKGROUND

• Traverse JH, Meyers P, Rafajdus A, Sharkey SW, Schwager S, Stanberry L, Herman R. Association Between Artificial Intelligence-Detected Features on the ECG and Presence of Microvascular Obstruction. Circ Cardiovasc Interv. 2026 Jan;19(1):e016104. doi: 10.1161/CIRCINTERVENTIONS.125.016104. Epub 2025 Nov 10. No abstract available.

  PMID: 41212803 BACKGROUND

• 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.

  PMID: 37284070 BACKGROUND

• De Maria GL, Scarsini R, Shanmuganathan M, Kotronias RA, Terentes-Printzios D, Borlotti A, Langrish JP, Lucking AJ, Choudhury RP, Kharbanda R, Ferreira VM; Oxford Acute Myocardial Infarction (OXAMI) Study Investigators; Channon KM, Garcia-Garcia HM, Banning AP. Angiography-derived index of microcirculatory resistance as a novel, pressure-wire-free tool to assess coronary microcirculation in ST elevation myocardial infarction. Int J Cardiovasc Imaging. 2020 Aug;36(8):1395-1406. doi: 10.1007/s10554-020-01831-7. Epub 2020 May 14.

  PMID: 32409977 BACKGROUND

• 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.

  PMID: 42541504 BACKGROUND

• Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.

  PMID: 37622654 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Hamdy S Mohamed, PHD

  Professor

  STUDY DIRECTOR

• Magdy I Eldesoky, PHD

  Assistent Professor

  STUDY DIRECTOR

• Mohamed A Ali, PHD

  Lecturer

  STUDY DIRECTOR

Central Study Contacts

Bakeer M Saleh, MSc

CONTACT

+201119427024; bakeer.saleeh@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow of adult cardiology at Aswan Heart Center MYF

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share