An observational study in ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN) and Acute Kidney Injury, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Assiut University · Observational
Among 36 studies in ST Elevation Myocardial Infarction by Assiut University — 19 open to participants now, 19 under way, none of them phase 3. ST Elevation Myocardial Infarction · Assiut University.
Among the 36 studies in ST Elevation Myocardial Infarction by Assiut University, this one is the 6th largest by planned enrollment of the 31 observational ones, is one of 6 that started in 2026, is one of 31 observational ones, reaches primary completion later than 15 of the 18 other live ones, and was the 34th registered.
850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.
This study's planned enrollment of 400 is above the median of 335 across 297 observational studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →19 of the 36 studies in ST Elevation Myocardial Infarction by Assiut University are open now, in 1 country. Each count lists the studies.
Of the 122 ST Elevation Myocardial Infarction studies recruiting now, 76 (62%) set no upper age limit and 20 (16%) stop at 75 or younger; 10 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →36 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 6 started in 2026.
Median enrollment 300 across the 5 interventional studies, 150 across the 31 observational. Of the 1 that completed or were terminated, 0 (0%) have results posted.
Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
2 of the studies in ST Elevation Myocardial Infarction by Assiut University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07263282Assiut UniversityLA Strain in Predicting Early Complication in STEMI After PPCI | 2026-12-01 |
| NCT07860086Assiut UniversityOn vs Off-hour PPCI in STEMI Patients | 2027-06-30 |
Among the 36 studies in ST Elevation Myocardial Infarction by Assiut University, from their registry updates:
Contrast-Induced Nephropathy (CIN) is a serious complication following primary percutaneous coronary intervention (PCI) in patients presenting with acute ST-segment elevation myocardial infarction (STEMI). While the standard Mehran Risk Score uses static baseline clinical and procedural variables, it lacks dynamic parameters reflecting acute myocardial ischemic duration. Total ischemic time-from symptom onset to balloon inflation-drives systemic inflammation, forward cardiac failure, and renal hypoperfusion.
This prospective observational validation cohort study aims to evaluate the independent predictive value of Total Ischemic Time for CIN in acute STEMI patients undergoing primary PCI. Additionally, it investigates whether integrating total ischemic duration into the classic Mehran Risk Score enhances discrimination accuracy, net reclassification, and calibration performance for early pre-procedural risk stratification.
Background:
Contrast-Induced Nephropathy (CIN) remains one of the most significant complications following primary percutaneous coronary intervention (PPCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI). The traditional Mehran Risk Score utilizes static baseline parameters (such as hypotension, IABP, CHF, age, anemia, diabetes, contrast volume, and baseline eGFR) to stratify CIN risk. However, it omits the duration of acute myocardial ischemia. Prolonged total ischemic time (the interval from symptom onset to first balloon inflation/device placement) triggers severe systemic inflammatory cascades, hemodynamic instability, and transient renal hypoperfusion, which may independently increase susceptibility to contrast-induced acute kidney injury.
Objectives:
To evaluate the independent predictive value of Total Ischemic Time for Contrast-Induced Nephropathy (CIN) in acute STEMI patients undergoing primary PCI.
To investigate whether integrating total ischemic duration into the classic Mehran Risk Score enhances its predictive performance, discrimination, calibration, and risk reclassification capacity.
Methods \& Procedure:
This prospective observational validation cohort study will recruit consecutive adult STEMI patients presenting to Assiut University Heart Hospital undergoing primary PCI within 12 hours of symptom onset. Total ischemic time (symptom-to-balloon time) will be precisely documented upon presentation. Baseline laboratory tests including serum creatinine, blood urea nitrogen (BUN), complete blood count (CBC), and blood glucose will be drawn prior to PCI. Serum creatinine will be re-evaluated at 24, 48, and 72 hours post-PCI to detect CIN (defined as an absolute increase in serum creatinine of ≥ 0.5 mg/dL or a relative increase of ≥ 25% from baseline within 48-72 hours post-contrast administration).
Statistical modeling will compare the performance of the classic Mehran Risk Score against a modified model incorporating total ischemic time using Area Under the Receiver Operating Characteristic Curve (AUROC), Net Reclassification Improvement (NRI), and Integrated Discrimination Improvement (IDI).
Consecutive adult patients aged >=18 years presenting with acute ST-segment elevation myocardial infarction (STEMI) within 12 hours of symptom onset who undergo emergency primary percutaneous coronary intervention (PPCI) at Assiut University Heart Hospital.
Inclusion Criteria:
Inclusion Criteria:
Willingness to participate, demonstrated by signed, obtained from the patient or an authorized family representative prior to data collection under approved institutional protocols.
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Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Consecutive adult STEMI patients presenting within 12 hours of symptom onset who undergo primary percutaneous coronary intervention (PPCI). Total ischemic time and baseline serum creatinine are measured, and renal function is monitored at 24, 48, and 72 hours post-PCI to evaluate Contrast-Induced Nephropathy (CIN).
Diagnostic Test: Total Ischemic Time Evaluation
Measurement and documentation of the time duration from symptom onset to primary PCI balloon inflation/device placement.
Incidence of Contrast-Induced Nephropathy (CIN)
Incidence of CIN, defined as an absolute increase in serum creatinine of ≥ 0.5 mg/dL or a relative increase of ≥ 25% from baseline values measured at 24, 48, and 72 hours following primary PCI.
Time frame: Up to 72 hours post-procedure
Serial Variations of Renal Biomarkers and Short-Term Clinical Outcomes
Tracking serial chronological variations of renal biomarker metrics including serum creatinine, blood urea nitrogen (BUN), and estimated glomerular filtration rate (eGFR) calculated via CKD-EPI 2021 equation, alongside the incidence of major adverse cardiovascular events (MACE), emergent renal replacement therapy, and short-term in-hospital mortality across total ischemic time sub-cohorts.
Time frame: Baseline, 24, 48, and 72 hours post-procedure, up to index hospital discharge (up to 7 days)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared to protect patient privacy and maintain strict confidentiality in accordance with the study protocol and institutional review board guidelines. Only aggregated study results will be made available upon publication.
Start is estimated for Oct 2026; primary completion for Jul 2028, 21 months later.
Of 122 non-industry observational studies under ST Elevation Myocardial Infarction, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 107. This study's planned 21 months is below that.
Counting every sponsor, half of 143 studies reached it within 38 months; a quarter within 20 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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ST Elevation Myocardial Infarction →