NCT07860086Not yet recruiting
On vs Off-hour PPCI in STEMI Patients
On- Versus Off-Hour Primary Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction Patients
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
ST-elevation myocardial infarction (STEMI) remains a leading cause of morbidity and mortality globally, and timely reperfusion with primary percutaneous coronary intervention (PPCI) is the gold-standard treatment1. Current guidelines recommend a door-to-balloon (DTB) time of 90 minutes or less, as the benefits of PPCI increase in direct correlation with the brevity of reperfusion time. However, there is consistent epidemiological evidence that STEMI patients presenting during off-hours (nights, weekends, and holidays) experience delays in reperfusion and worse in-hospital outcomes compared to those presenting during regular business hours. Two competing hypotheses dominate the literature. The systems hypothesis suggests that delays in care delivery during nights and weekends-including longer catheterization laboratory activation time, reduced availability of experienced operators, and logistical constraints-are the primary drivers of worse outcomes. In support of this, some studies have found that the mortality difference between off-hours and on-hours presentations is attenuated after adjusting for DTB time (Chung et al., 2020), suggesting that system-level process measures may be actionable targets for quality improvement. Alternatively, the intrinsic severity hypothesis suggests that nocturnal STEMI presentations represent inherently more severe infarcts-characterized by higher thrombus burden, larger myocardial infarction size, and more frequent complications such as cardiogenic shock-independent of how rapidly reperfusion is achieved. Recent studies examining circadian variation in infarct size and myocardial injury biomarkers have found evidence of larger infarcts and worse systolic function in nocturnal-onset STEMI, with long-term mortality implications. Critically, the vast majority of evidence in this field derives from retrospective registry data, particularly from North American and Western European cohorts. Data from the Middle East and North Africa (MENA) region, where demographic and healthcare system profiles differ substantially from developed nations, are essentially absent from the literature. Furthermore, contemporary data on the prospective relationships between time-of-PPCI, operator experience, procedural quality parameters (such as myocardial blush grade and ST-segment resolution), and outcomes remain limited. A prospective study with granular intra-procedural data collection offers the opportunity to: (1) quantify the magnitude of the off-hours effect in a Middle Eastern context; (2) decompose the DTB time into its components to identify specific system bottlenecks; (3) assess whether operator seniority and team composition confound or mediate the off-hours effect6; and (4) evaluate whether procedural quality metrics (reperfusion grade, thrombus burden, microvascular perfusion) differ between daytime and nighttime PPCI and contribute to outcome disparities independent of system factors.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 450 (estimated)
- First submitted
- 11 Sept 2026
- Start date
- 15 Oct 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Assiut University
- Diseases
- Coronary artery disease
- NCT number
- NCT07860086
What you commit to
- Study type: Observational
- Planned participants: 450
- From 15 Oct 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intra-aortic balloon pump or mechanical circulatory support initiated prior to diagnostic angiography (devices initiated post-PPCI are not exclusions)
Other illness
- Cardiogenic shock secondary to mechanical complication (acute mitral regurgitation, ventricular septal defect, free wall rupture) rather than myocardial infarction.
- Expected survival \<30 days from non-cardiac causes.
Lab values
- Previous myocardial infarction with known LV dysfunction (baseline LVEF \<30%).
Other
- Indication for emergent coronary artery bypass grafting at presentation (e.g., left main occlusion unsuitable for PCI).
Who the study is looking for
- Age ≥18 years
- Acute STEMI eligible for Primary Percutaneous Coronary Intervention
- Symptom onset ≤24 hours prior to hospital presentation
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assiut University Heart Hospital Coordinator of this site? Confirm its status | Asyut | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.