Építés alatt – nem éles oldal
Belépés

NCT07860086Toborzás még nem indult

On vs Off-hour PPCI in STEMI Patients

On- Versus Off-Hour Primary Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction Patients

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 6.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Megfigyeléses
Résztvevők száma
450 (tervezett)
Első benyújtás
2026. szept. 11.
Kezdés
2026. okt. 15.
Elsődleges befejezés
2027. jún. 30.
Fő szponzor
Assiut University
NCT-szám
NCT07860086

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Tervezett résztvevők: 450
  • 2026. okt. 15. és az elsődleges befejezés (2027. jún. 30.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

Korábbi kezelés

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

Más betegség

  • 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.

Laborértékek

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

Egyéb

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

Kiket keres a vizsgálat

  • Age ≥18 years
  • Acute STEMI eligible for Primary Percutaneous Coronary Intervention
  • Symptom onset ≤24 hours prior to hospital presentation

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Assiut University Heart HospitalAsyutEgyiptomIsmeretlen állapot

Te vagy a koordinátor? Erősítsd meg az adatokat

Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.