On vs Off-hour PPCI in STEMI Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Acute STEMI eligible for Primary Percutaneous Coronary Intervention

Symptom onset ≤24 hours prior to hospital presentation

Disqualifiers

Previous myocardial infarction with known LV dysfunction (baseline LVEF <30%).

Cardiogenic shock secondary to mechanical complication (acute mitral regurgitation, ventricular septal defect, free wall rupture) rather than myocardial infarction.

Indication for emergent coronary artery bypass grafting at presentation (e.g., left main occlusion unsuitable for PCI).

Intra-aortic balloon pump or mechanical circulatory support initiated prior to diagnostic angiography (devices initiated post-PPCI are not exclusions)

Trial population

All Acute STEMI Patients undergoing PPCI in AUHH

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

450 Participants
are grouped into 2 trial groups
Group A: On-hour Group
Group B: Off-Hour Group

Trial outcomes

Primary outcomes

1

In-hospital 4-point MACE

In-hospital 4-point MACE: Composite binary outcome (yes/no) incorporating any of: all-cause mortality, reinfarction, ischemic stroke, Emergent Target Vessel Revascularization (TVR). For analysis, the composite will be analyzed as a binary variable

Time frame
Periprocedural

Secondary outcomes

1

Individual MACE Components

Binary Outcome

Time frame
Periprocedural
2

Door-to-Balloon Time Components

Measured in Minutes

Time frame
Periprocedural
3

TIMI Flow

Measured in grades (0-3)

Time frame
Periprocedural
4

LVEF at discharge

In Percentage

Time frame
Periprocedural

Other outcomes

Sponsors and contacts

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