ST Elevation (STEMI) Myocardial Infarction of Other SitesNCT07175259
Relation of Total Ischemic Time to Repolarization Indices and Their Impact on Outcomes Among STEMI Patients Undergoing Primary PCI
An observational study of ST Elevation (STEMI) Myocardial Infarction of Other Sites and Repolarization Indices, run by Assiut University.
Trial summary
1. Evaluate The impact of early versus late presentation on electrocardiographic ventricular repolarization indices. 2. To assess the association between repolarization indices among early, late presentation in relation to in-hospital ventricular arrhythmias, in-hospital MACE, and 6 months MACE. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ST Elevation (STEMI) Myocardial Infarction of Other Sites, Repolarization Indices, Total Ischemic Time
- What is being tested?
- Echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Dec 2026
- Phase
- Observational
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 will include patients presenting with ST-elevation myocardial infarction (STEMI) who are admitted to the coronary care unit and undergo primary percutaneous coronary intervention (PCI) as the reperfusion strategy. Eligible patients will be adults presenting within the accepted therapeutic window for primary PCI. The final sample will thus represent a consecutive cohort of STEMI patients undergoing primary PCI, allowing assessment of the relationship between total ischemic time and repolarization indices (QTc, Tpe interval, Tpe/QT ratio, etc.), and their subsequent impact on both short- and long-term clinical outcomes.
Who may be able to join
- Patients presenting with acute STEMI undergoing primary PCI
Who cannot join
- 1. Prior myocardial infarction or CABG. 2. Left or right bundle branch block. 3. Atrial fibrillation. 4. Cardiac arrest or cardiogenic shock 5. Valvular heart disease (severe). 6. Use of QT-prolonging medications as anti-arrhythmic, anti-psychotic, anti-depressant and some types of antibiotics.
- 7. Poor quality ECG tracings. 8. Chronic kidney disease stage ≥3. 9. Electrolyte abnormalities at admission 10. Undetermined date of pain
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
- Evaluate The impact of early versus late presentation on electrocardiographic ventricular repolarization indices.
- To assess the association between repolarization indices among early, late presentation in relation to in-hospital ventricular arrhythmias, in-hospital MACE, and 6 months MACE.
Read the detailed description
ST-elevation myocardial infarction (STEMI) remains a time-critical cardiovascular emergency. Early reperfusion is essential to reduce myocardial necrosis, preserve ventricular function, and improve survival outcomes. However, delayed presentation remains a significant problem, especially in developing countries, leading to larger infarct sizes and worse clinical outcomes. (Park J, Choi KH, Lee JM, et al. 2019) Ventricular repolarization indices including QT interval ( Measured from the onset of the QRS complex (beginning of Q wave or R if no Q visible)To the end of the T wave returning to the isoelectric line ), QT dispersion (QTD) ( Calculated as: QTD = QT{max} - QT{min}), corrected QT interval (QTc) Calculated using Bazett's formula: QTc = {QT}/{sqrt{RR}. Corrected QT dispersion (cQTD or QTcd) Calculated as: cQTD = QTc{max}- QTc{min}.TPE/QT ratio, Calculated as: {TPE/QT Ratio} = {TPE}/{QT}, T peak-to-Tend interval (TPE) ( Measured from the peak of the T wave To the end of the T wave returning to the isoelectric line ), are non-invasive markers of electrical instability and myocardial injury. Prolongation of these indices has been associated with worse microvascular perfusion (including the no-reflow phenomenon (Abdelmeguid AE, Abdelhamid SM, Abdelhameed KM, et al. 2023) and lower myocardial blush grade [MBG]) (Liu X, Li Y, Li D, et al. 2021) and higher rates of major adverse cardiovascular events (MACE). (Çağdaş M, Rencüzoğulları İ, Karakoyun S, et al. 2018, Abdelmeguid AE, Abdelhamid SM, Abdelhameed KM, et al. 2023, Liu X, Li Y, Li D, et al. 2021) There is limited data assessing the direct relationship between early vs late presentation, repolarization indices measured before and after PCI, and subsequent outcomes in STEMI patients, particularly in our local population.
This study aims to fill this gap by investigating whether timing of presentation significantly affects repolarization indices and whether these indices can predict in-hospital and six-month clinical outcomes.
- Conditions
- ST Elevation (STEMI) Myocardial Infarction of Other Sites, Repolarization Indices, Total Ischemic Time, Primary Percutaneous Coronary Intervention
- Being tested
- Echocardiography
- 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.
EchocardiographyRadiation
Simple, bedsides, non invasive
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between total ischemic time and ventricular repolarization indices
Correlation between total ischemic time (symptom onset to balloon time) and ECG-derived repolarization parameters, including QT interval, corrected QT (QTc), Tpeak-Tend interval, and Tpeak-Tend/QT ratio. Analysis will evaluate linear correlations and threshold effects.
Measured: 6 months
Secondary outcomes (3)
In-hospital ventricular arrhythmias
Occurrence of sustained ventricular tachycardia or ventricular fibrillation documented during index hospitalization.
Measured: 7 dayes
In-hospital major adverse cardiovascular events (MACE)
Composite of all-cause death, reinfarction (per universal definition of MI), and new or worsening heart failure during index hospitalization.
Measured: 7 days
Six-month major adverse cardiovascular events (MACE)
Composite of cardiovascular mortality, hospitalization for heart failure or recurrent ACS, and target lesion revascularization (TLR) at follow-up.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ST Elevation (STEMI) Myocardial Infarction of Other SitesStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Monazea Menisy Khaled, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175259
- Sponsor's protocol ID
- Repolarization indices PPCI
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang X, Zhang L, Gao C, Zhu J, Yang X. Tpeak-Tend/QT interval predicts ST-segment resolution and major adverse cardiac events in acute ST-segment elevation myocardial infarction patients undergoing percutaneous coronary intervention. Medicine (Baltimore). 2018 Oct;97(43):e12943. doi: 10.1097/MD.0000000000012943.
PubMed 30412109Rao SV, O'Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, Baber U, Baker H, Cohen MG, Cruz-Ruiz M, Davis LL, de Lemos JA, DeWald TA, Elgendy IY, Feldman DN, Goyal A, Isiadinso I, Menon V, Morrow DA, Mukherjee D, Platz E, Promes SB, Sandner S, Sandoval Y, Schunder R, Shah B, Stopyra JP, Talbot AW, Taub PR, Williams MS. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Apr;151(13):e771-e862. doi: 10.1161/CIR.0000000000001309. Epub 2025 Feb 27.
PubMed 40014670Demidova MM, Carlson J, Erlinge D, Azarov JE, Platonov PG. Prolonged Tpeak-Tend interval is associated with ventricular fibrillation during reperfusion in ST-elevation myocardial infarction. Int J Cardiol. 2019 Apr 1;280:80-83. doi: 10.1016/j.ijcard.2019.01.008. Epub 2019 Jan 4.
PubMed 30661844Abu Shajahan M, Mohideen B, P A J, Thaha SM, Ashraf AR, Nazar I, Nair RG, Fakhrudeen Mushthak S, Suresh AL. Prognostic Value of QTc Dispersion in Acute Myocardial Infarction. Cureus. 2025 Apr 23;17(4):e82846. doi: 10.7759/cureus.82846. eCollection 2025 Apr.
PubMed 40416232Cagdas M, Karakoyun S, Rencuzogullari I, Karabag Y, Yesin M, Uluganyan M, Gursoy MO, Artac I, Ilis D, Efe SC, Tasar O. Relationship between R-wave peak time and no-reflow in ST elevation myocardial infarction treated with a primary percutaneous coronary intervention. Coron Artery Dis. 2017 Jun;28(4):326-331. doi: 10.1097/MCA.0000000000000477.
PubMed 28207567