ST Elevation (STEMI) Myocardial InfarctionNCT07876791
Multimodality Assessment of Myocardial Reperfusion After Primary Percutaneous Coronary Intervention
An observational study of ST Elevation (STEMI) Myocardial Infarction and Microvascular Obstruction (MVO), run by Assiut University.
Trial summary
This study aims to evaluate myocardial reperfusion in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation (STEMI) Myocardial Infarction, Microvascular Obstruction (MVO)
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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.
Who may be able to join
- 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.
Show all 18Show fewer
- Ability to undergo contrast-enhanced CMR during the index admission.
- Written informed consent for study participation and follow-up. Exclusion criteria
- 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.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multimodality Assessment of Myocardial Reperfusion After Primary Percutaneous Coronary Intervention: Integration of Artificial Intelligence-Derived Electrocardiogram Features, Angiographic Parameters, and Cardiac Magnetic Resonance.
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.
Read more
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.
Read the detailed description
Background ST-segment elevation myocardial infarction (STEMI) is usually caused by acute thrombotic coronary occlusion and requires rapid reperfusion. Contemporary acute coronary syndrome guidance prioritizes primary percutaneous coronary intervention (PCI) when it can be delivered promptly, because shortening total ischemic time is central to myocardial salvage.
Restoration of epicardial patency, however, does not guarantee restoration of tissue-level perfusion. A patient may have a technically successful primary PCI with final TIMI grade 3 flow yet still have substantial coronary microvascular injury. Distal embolization, ischemia-reperfusion injury, endothelial swelling, capillary plugging, edema and intramyocardial hemorrhage can produce microvascular obstruction (MVO), which is associated with larger infarct size, impaired ventricular recovery and adverse remodeling.
Conventional bedside and cath-lab markers of myocardial reperfusion include ST-segment resolution (STR), final TIMI flow, myocardial blush grade (MBG) and corrected TIMI frame count (cTFC). These measurements are clinically accessible but capture different components of reperfusion and may remain discordant. Angiography-derived indices of microcirculatory resistance provide an additional pressure-wire-free estimate of microvascular dysfunction and have shown association with CMR-defined MVO and infarct size after STEMI.
Cardiac magnetic resonance (CMR) provides a reference tissue-level assessment after reperfused STEMI. Cine imaging quantifies ventricular volumes and function, while late gadolinium enhancement can quantify infarct size and identify MVO. When appropriate sequences are available, CMR can additionally characterize myocardial edema and intramyocardial hemorrhage. This makes CMR particularly suitable for validating whether electrical and angiographic markers truly reflect myocardial reperfusion.
Artificial intelligence (AI) offers a complementary approach to the routine 12-lead ECG. Traverse and colleagues reported that AI-detected features from pre- and post-reperfusion ECGs were associated with CMR-defined MVO after STEMI, supporting the concept that residual electrical signatures after reperfusion may contain information beyond conventional ST-segment analysis. Rather than developing a new deep-learning system from a small cohort, the present protocol proposes use of a validated AI-ECG platform to extract prespecified features, which will then be integrated with conventional ECG and angiographic variables and tested against CMR-defined myocardial injury.
The proposed study therefore treats reperfusion as a multimodality phenotype: electrical recovery on ECG, epicardial and tissue-level angiographic reperfusion in the cath lab, and tissue injury on CMR. Follow-up echocardiography will then determine whether this early phenotype is associated with subsequent left-ventricular (LV) recovery or adverse remodeling.
Rationale and Research Gap Previous studies have generally evaluated ECG, angiographic microvascular indices, or CMR findings in isolation. The recent AI-ECG study demonstrated proof-of-concept for identifying MVO from AI-detected ECG features, while recent angiography-derived microvascular resistance studies demonstrated incremental association with CMR-defined MVO and infarct size (2,5). However, the incremental value of integrating AI-derived ECG features with readily available angiographic reperfusion parameters in a prospective primary-PCI cohort remains insufficiently characterized, particularly when CMR is used as the tissue-level reference and later LV remodeling is assessed.
The proposed study will therefore determine whether AI-derived electrical reperfusion markers add information beyond conventional STR, MBG and cTFC for identifying CMR-defined MVO. The study will also evaluate whether the multimodality reperfusion phenotype is associated with infarct size, LV function and subsequent LV remodeling.
Research Question Can integration of artificial intelligence-derived ECG features with conventional electrocardiographic and angiographic reperfusion parameters improve identification of cardiac magnetic resonance-defined microvascular injury after successful primary PCI in patients with STEMI, and is this multimodality reperfusion phenotype associated with subsequent LV remodeling? Hypotheses Primary hypothesis Persistent abnormal AI-derived ECG features after successful primary PCI, particularly limited improvement from pre- to post-reperfusion ECG, are independently associated with CMR-defined MVO.
Secondary mechanistic hypotheses
- Impaired angiographic tissue reperfusion, expressed by lower MBG and higher cTFC despite final epicardial TIMI 3 flow, is associated with CMR-defined MVO and larger infarct size.
- A multimodality model combining clinical variables, conventional ECG, AI-derived ECG features and angiographic parameters discriminates CMR-defined MVO better than conventional reperfusion markers alone.
- CMR-defined MVO and larger infarct size are associated with less improvement in LVEF and GLS and with adverse LV remodeling at 3-6 months.
- Patients with final TIMI 3 flow but discordant electrical/angiographic tissue-level reperfusion represent an occult microvascular-failure phenotype with greater CMR injury.
Aim of the Work To evaluate the integrated value of artificial intelligence-derived ECG features and angiographic reperfusion parameters for identification of CMR-defined microvascular injury following successful primary PCI in patients with STEMI and to assess their relationship with subsequent LV functional recovery and remodeling.
- Keywords
- Primary Percutaneous Coronary intervention, ST-Elevation Myocardial Ifarction, Microvascular Obstruction, Cardiac Magnetic Resonance, Artificial Intelligence, Electrocardiography, Myocardial Reperfusion
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
AUROC for prediction of CMR detected MVO
Measured: 7 days
Infarct Size
Percentage of LV myocardial Mass on CMR
Measured: 7 days
Left Ventricular ejection fraction
LVEF % by CMR
Measured: 7 days
intramyocardial hemorrhage
Presence or absence on CMR.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for ST Elevation (STEMI) Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 90 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bakeer Mohamed Bakeer, Assiut University
- Investigators
- Hamdy S Mohamed, PHD, Study director, ProfessorMagdy I Eldesoky, PHD, Study director, Assistent ProfessorMohamed A Ali, PHD, Study director, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876791
- Sponsor's protocol ID
- AUH-MD-PCI-AI-2026-01
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9639373Gibson 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.
PubMed 8598078Schulz-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.
PubMed 32160925Kramer 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.
PubMed 32089132Pollio 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.
PubMed 41482053Wang 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.
PubMed 38866108Wen 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.
PubMed 38711790Traverse 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.
PubMed 41212803Fan 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 37284070De 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.
PubMed 32409977Sheng 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 42541504Byrne 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.
PubMed 37622654
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Assessment of Myocardial Reperfusion After Primary Percutaneous Coronary Intervention: Integration of Artificial Intelligence-Derived Electrocardiogram Features, Angiographic Parameters, and Cardiac Magnetic Resonance.
- ClinicalTrials.gov ID
- NCT07876791
- Acronym / sponsor ID
- AUH-MD-PCI-AI-2026-01
- Keywords
- Primary Percutaneous Coronary intervention, ST-Elevation Myocardial Ifarction, Microvascular Obstruction, Cardiac Magnetic Resonance, Artificial Intelligence, Electrocardiography, Myocardial Reperfusion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 15 Oct 2026 (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.
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.
Detailed description
Background ST-segment elevation myocardial infarction (STEMI) is usually caused by acute thrombotic coronary occlusion and requires rapid reperfusion. Contemporary acute coronary syndrome guidance prioritizes primary percutaneous coronary intervention (PCI) when it can be delivered promptly, because shortening total ischemic time is central to myocardial salvage.
Restoration of epicardial patency, however, does not guarantee restoration of tissue-level perfusion. A patient may have a technically successful primary PCI with final TIMI grade 3 flow yet still have substantial coronary microvascular injury. Distal embolization, ischemia-reperfusion injury, endothelial swelling, capillary plugging, edema and intramyocardial hemorrhage can produce microvascular obstruction (MVO), which is associated with larger infarct size, impaired ventricular recovery and adverse remodeling.
Conventional bedside and cath-lab markers of myocardial reperfusion include ST-segment resolution (STR), final TIMI flow, myocardial blush grade (MBG) and corrected TIMI frame count (cTFC). These measurements are clinically accessible but capture different components of reperfusion and may remain discordant. Angiography-derived indices of microcirculatory resistance provide an additional pressure-wire-free estimate of microvascular dysfunction and have shown association with CMR-defined MVO and infarct size after STEMI.
Cardiac magnetic resonance (CMR) provides a reference tissue-level assessment after reperfused STEMI. Cine imaging quantifies ventricular volumes and function, while late gadolinium enhancement can quantify infarct size and identify MVO. When appropriate sequences are available, CMR can additionally characterize myocardial edema and intramyocardial hemorrhage. This makes CMR particularly suitable for validating whether electrical and angiographic markers truly reflect myocardial reperfusion.
Artificial intelligence (AI) offers a complementary approach to the routine 12-lead ECG. Traverse and colleagues reported that AI-detected features from pre- and post-reperfusion ECGs were associated with CMR-defined MVO after STEMI, supporting the concept that residual electrical signatures after reperfusion may contain information beyond conventional ST-segment analysis. Rather than developing a new deep-learning system from a small cohort, the present protocol proposes use of a validated AI-ECG platform to extract prespecified features, which will then be integrated with conventional ECG and angiographic variables and tested against CMR-defined myocardial injury.
The proposed study therefore treats reperfusion as a multimodality phenotype: electrical recovery on ECG, epicardial and tissue-level angiographic reperfusion in the cath lab, and tissue injury on CMR. Follow-up echocardiography will then determine whether this early phenotype is associated with subsequent left-ventricular (LV) recovery or adverse remodeling.
Rationale and Research Gap Previous studies have generally evaluated ECG, angiographic microvascular indices, or CMR findings in isolation. The recent AI-ECG study demonstrated proof-of-concept for identifying MVO from AI-detected ECG features, while recent angiography-derived microvascular resistance studies demonstrated incremental association with CMR-defined MVO and infarct size (2,5). However, the incremental value of integrating AI-derived ECG features with readily available angiographic reperfusion parameters in a prospective primary-PCI cohort remains insufficiently characterized, particularly when CMR is used as the tissue-level reference and later LV remodeling is assessed.
The proposed study will therefore determine whether AI-derived electrical reperfusion markers add information beyond conventional STR, MBG and cTFC for identifying CMR-defined MVO. The study will also evaluate whether the multimodality reperfusion phenotype is associated with infarct size, LV function and subsequent LV remodeling.
Research Question Can integration of artificial intelligence-derived ECG features with conventional electrocardiographic and angiographic reperfusion parameters improve identification of cardiac magnetic resonance-defined microvascular injury after successful primary PCI in patients with STEMI, and is this multimodality reperfusion phenotype associated with subsequent LV remodeling? Hypotheses Primary hypothesis Persistent abnormal AI-derived ECG features after successful primary PCI, particularly limited improvement from pre- to post-reperfusion ECG, are independently associated with CMR-defined MVO.
Secondary mechanistic hypotheses
- Impaired angiographic tissue reperfusion, expressed by lower MBG and higher cTFC despite final epicardial TIMI 3 flow, is associated with CMR-defined MVO and larger infarct size.
- A multimodality model combining clinical variables, conventional ECG, AI-derived ECG features and angiographic parameters discriminates CMR-defined MVO better than conventional reperfusion markers alone.
- CMR-defined MVO and larger infarct size are associated with less improvement in LVEF and GLS and with adverse LV remodeling at 3-6 months.
- Patients with final TIMI 3 flow but discordant electrical/angiographic tissue-level reperfusion represent an occult microvascular-failure phenotype with greater CMR injury.
Aim of the Work To evaluate the integrated value of artificial intelligence-derived ECG features and angiographic reperfusion parameters for identification of CMR-defined microvascular injury following successful primary PCI in patients with STEMI and to assess their relationship with subsequent LV functional recovery and remodeling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Cardiac MRI-Detected Microvascular Obstruction After Primary PCI
Time frame: 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.
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.
4 secondary outcomes
Predictive performance of combined model
Time frame: 7 days
Infarct Size
Time frame: 7 days
Left Ventricular ejection fraction
Time frame: 7 days
intramyocardial hemorrhage
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 9639373van '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.
- Background: PubMed 8598078Gibson 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.
- Background: PubMed 32160925Schulz-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.
- Background: PubMed 32089132Kramer 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.
- Background: PubMed 41482053Pollio 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.
- Background: PubMed 38866108Wang 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.
- Background: PubMed 38711790Wen 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.
- Background: PubMed 41212803Traverse 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.
- Background: PubMed 37284070Fan 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.
- Background: PubMed 32409977De 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.
- Background: PubMed 42541504Sheng 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.
- Background: PubMed 37622654Byrne 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.
- Individual participant dataSharing planned: No
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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.
Hamdy S Mohamed, PHD study director
Professor
Magdy I Eldesoky, PHD study director
Assistent Professor
Mohamed A Ali, PHD study director
Lecturer
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation (STEMI) Myocardial Infarction and Microvascular Obstruction (MVO), run by Assiut University.
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 18 inclusion and 0 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: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bakeer M Saleh, MSc (+201119427024, bakeer.saleeh@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Cardiac MRI-Detected Microvascular Obstruction After Primary PCI (time frame: 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.). 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 NCT07876791, which also lists 12 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 15 Oct 2026.