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
- 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 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Total Ischemic Time to Repolarization Indices and Their Impact on Outcomes Among STEMI Patients Undergoing Primary PCI
- ClinicalTrials.gov ID
- NCT07175259
- Acronym / sponsor ID
- Repolarization indices PPCI
- Conditions
- ST Elevation (STEMI) Myocardial Infarction of Other Sites, Repolarization Indices, Total Ischemic Time, Primary Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Sep 2025 (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.
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Patients presenting with acute STEMI undergoing primary PCI
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographySimple, bedsides, non invasive | Radiation | – |
Primary outcome
Association between total ischemic time and ventricular repolarization indices
Time frame: 6 months
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.
3 secondary outcomes
In-hospital ventricular arrhythmias
Time frame: 7 dayes
In-hospital major adverse cardiovascular events (MACE)
Time frame: 7 days
Six-month major adverse cardiovascular events (MACE)
Time frame: 6 months
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 16 Sep 2025.
- Results publication: PubMed 30412109Wang 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.
- Results publication: PubMed 40014670Rao 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.
- Results publication: PubMed 30661844Demidova 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.
- Results publication: PubMed 40416232Abu 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.
- Results publication: PubMed 28207567Cagdas 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.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation (STEMI) Myocardial Infarction of Other Sites and Repolarization Indices, 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 1 inclusion and 2 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 16 Sep 2025. 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 Ahmed Monazea Menisy, Principal investigator (+201032180540, Ahmed.17289555@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between total ischemic time and ventricular repolarization indices (time frame: 6 months). 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 NCT07175259, which also lists 5 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 16 Sep 2025.