- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07860086
On vs Off-hour PPCI in STEMI Patients (On vs Off PPCI)
On- Versus Off-Hour Primary Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction Patients
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.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Muhammad Hatem, Bachelor's
- Telefonszám: 01014321553
- E-mail: muhammad.maghraby@gmail.com
Tanulmányi helyek
-
-
Asyut Governorate
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Asyut, Asyut Governorate, Egyiptom, 71515
- Assiut University Heart Hospital
-
Kapcsolatba lépni:
- Muhammad Hatem Maghraby, Bachelor's
- Telefonszám: 01014321553
- E-mail: muhammad.maghraby@gmail.com
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
All Acute STEMI Patients undergoing PPCI in AUHH
Leírás
Inclusion Criteria:
- Age ≥18 years
- Acute STEMI eligible for Primary Percutaneous Coronary Intervention
- Symptom onset ≤24 hours prior to hospital presentation
Exclusion Criteria:
- 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)
- Expected survival <30 days from non-cardiac causes.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Megfigyelési modellek: COHORT
- Időperspektívák: PROSPECTIVE
Kohorszok és beavatkozások
Csoport / Kohorsz |
|---|
|
On-hour Group
Patients presenting from 8:00 AM to 8:00PM |
|
Off-Hour Group
Patients presenting from 8:00 PM to 8:00 AM, additional analysis with further stratification of holidays and weenends added to the off-hour group. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
In-hospital 4-point MACE
Időkeret: Periprocedural
|
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 |
Periprocedural
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Individual MACE Components
Időkeret: Periprocedural
|
Binary Outcome |
Periprocedural
|
|
Door-to-Balloon Time Components
Időkeret: Periprocedural
|
Measured in Minutes |
Periprocedural
|
|
TIMI Flow
Időkeret: Periprocedural
|
Measured in grades (0-3) |
Periprocedural
|
|
LVEF at discharge
Időkeret: Periprocedural
|
In Percentage |
Periprocedural
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi szék: Hamdy Shams Eddin Mohammad Taher, MD, Assiut University
- Tanulmányi szék: Magdy Ibrahim Aldesowky Mohamed Algowhary, MD, Assiut University
Publikációk és hasznos linkek
Általános kiadványok
- Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
- Moller JE, Engstrom T, Jensen LO, Eiskjaer H, Mangner N, Polzin A, Schulze PC, Skurk C, Nordbeck P, Clemmensen P, Panoulas V, Zimmer S, Schafer A, Werner N, Frydland M, Holmvang L, Kjaergaard J, Sorensen R, Lonborg J, Lindholm MG, Udesen NLJ, Junker A, Schmidt H, Terkelsen CJ, Christensen S, Christiansen EH, Linke A, Woitek FJ, Westenfeld R, Mobius-Winkler S, Wachtell K, Ravn HB, Lassen JF, Boesgaard S, Gerke O, Hassager C; DanGer Shock Investigators. Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. N Engl J Med. 2024 Apr 18;390(15):1382-1393. doi: 10.1056/NEJMoa2312572. Epub 2024 Apr 7.
- Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.
- Glaser R, Naidu SS, Selzer F, Jacobs AK, Laskey WK, Srinivas VS, Slater JN, Wilensky RL. Factors associated with poorer prognosis for patients undergoing primary percutaneous coronary intervention during off-hours: biology or systems failure? JACC Cardiovasc Interv. 2008 Dec;1(6):681-8. doi: 10.1016/j.jcin.2008.08.020.
- Ma WJ, Gao SD, Huang SZ, Lin XZ, Yang YJ, Yu MY; Quality Control & Improvement Center of Cardiovascular Intervention of Beijing. Off-hours admission does not impact outcomes in patients undergoing primary percutaneous coronary intervention and with a first medical contact-to-device time within 90 min. Chin Med J (Engl). 2021 Jun 24;134(15):1795-1802. doi: 10.1097/CM9.0000000000001621.
- Li X, Ge Z, Kan J, Anjum M, Xie P, Chen X, Khan HS, Guo X, Saghir T, Chen J, Gill BUA, Guo N, Sheiban I, Raza A, Wei Y, Chen F, Mintz GS, Zhang JJ, Stone GW, Chen SL; IVUS-ACS Investigators. Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention in acute coronary syndromes (IVUS-ACS): a two-stage, multicentre, randomised trial. Lancet. 2024 May 11;403(10439):1855-1865. doi: 10.1016/S0140-6736(24)00282-4. Epub 2024 Apr 8.
- 16. Ishihara, M., Inoue, I., Kawagoe, T., Shimatani, Y., Kurisu, S., Nishioka, K., Umemura, S., & Nakamura, S. (2008). Circadian variation of acute myocardial infarction in patients with diabetes mellitus. Journal of the American College of Cardiology, 52(5), 343-346. https://doi.org/10.1016/j.jacc.2008.04.035
- 15. Yonetsu, T., Kakuta, T., & Tanaka, A. (2022). Circadian variations of ischemic burden among patients with myocardial infarction undergoing primary percutaneous coronary intervention. Circulation: Cardiovascular Interventions, 15(7), e011369. https://doi.org/10.1161/CIRCINTERVENTIONS.112.969022
- 14. Mert, M., Yilmaz, A., Gül, A. E., Güngör, B., & Özcan, K. S. (2019). On- versus off-hours presentation and mortality of ST-segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention. Cardiovascular Revascularization Medicine, 20(10), 850-855. https://doi.org/10.1016/j.carrev.2019.01.001
- 13. Giri, J., Munir, A. B., Geisler, T. P., Greenberg, J. W., Rajamanoharan, R., Ramu, B., Safford, R. E., Toma, C., Whitman, G. J., & Sartori, S. (2024). Primary percutaneous coronary intervention in STEMI: SCAI 2024 guideline summary. Medscape Cardiology, 1-15.
- Bulluck H, Nicholas J, Crimi G, White SK, Ludman AJ, Pica S, Raineri C, Cabrera-Fuentes HA, Yellon D, Rodriguez-Palomares J, Garcia-Dorado D, Hausenloy DJ. Circadian variation in acute myocardial infarct size assessed by cardiovascular magnetic resonance in reperfused STEMI patients. Int J Cardiol. 2017 Mar 1;230:149-154. doi: 10.1016/j.ijcard.2016.12.030. Epub 2016 Dec 19.
- Seneviratna A, Lim GH, Devi A, Carvalho LP, Chua T, Koh TH, Tan HC, Foo D, Tong KL, Ong HY, Richards AM, Yew CK, Chan MY. Circadian Dependence of Infarct Size and Acute Heart Failure in ST Elevation Myocardial Infarction. PLoS One. 2015 Jun 3;10(6):e0128526. doi: 10.1371/journal.pone.0128526. eCollection 2015.
- 9. Choi, J., Lee, T., Yang, C., Cairns, J., Roston, T. M., Moghaddam, N., Singer, J., Wong, G., & Fordyce, C. B. (2025). Association of daytime vs. non-daytime presentation with reperfusion times and clinical outcomes among STEMI patients complicated by cardiogenic shock. European Heart Journal, 46 (Supplement_1), ehaf784.1866. https://doi.org/10.1093/eurheartj/ehaf784.1866
- Takamizawa K, Gohbara M, Hanajima Y, Tsutsumi K, Kirigaya H, Kirigaya J, Nakahashi H, Minamimoto Y, Kimura Y, Kawaura N, Matsushita K, Okada K, Konishi M, Iwahashi N, Kosuge M, Sugano T, Ebina T, Hibi K. Long-term outcomes and operators' experience in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. Cardiovasc Interv Ther. 2025 Jan;40(1):57-67. doi: 10.1007/s12928-024-01059-5. Epub 2024 Oct 27.
- Naumann D, Fischer J, Gmeiner J, Lusebrink E, Beer BN, Grieger M, Giousouf A, Schrage B, Stremmel C, Massberg S, Orban M, Scherer C. The association of off-hour vs. on-hour intensive care unit admission time with mortality in patients with cardiogenic shock: a retrospective multi-centre analysis. Eur Heart J Acute Cardiovasc Care. 2024 May 7;13(4):347-353. doi: 10.1093/ehjacc/zuae012.
- Peng H, Sun Z, Di B, Ding X, Chen H, Li H. Contemporary impact of circadian symptom-onset patterns of acute ST-Segment elevation myocardial infarction on long-term outcomes after primary percutaneous coronary intervention. Ann Med. 2021 Dec;53(1):247-256. doi: 10.1080/07853890.2020.1863457.
- 4. Mahmoud, K. D., Nijsten, M. W., Wieringa, W. G., Ottervanger, J. P., Holmes, D. R., Hillege, H. L., van 't Hof, A. W., & Lipsic, E. (2012). Circadian variations of ischemic burden among patients with myocardial infarction undergoing primary percutaneous coronary intervention. Circulation: Cardiovascular Interventions, 5(4), 513-519. https://doi.org/10.1161/CIRCINTERVENTIONS.112.969022.
- Rashid MK, Wells G, So DY, Chong AY, Dick A, Froeschl M, Glover C, Hibbert B, Labinaz M, Russo J, Bernick J, Le May M. Off-Hours Presentation, Door-to-Balloon Time, and Clinical Outcomes in Patients Referred for Primary Percutaneous Coronary Intervention. J Invasive Cardiol. 2023 Apr;35(4):E185-E193. doi: 10.25270/jic/22.00367. Epub 2023 Feb 24.
- Jayawardana S, Salas-Vega S, Cornehl F, Krumholz HM, Mossialos E. The relationship between off-hours admissions for primary percutaneous coronary intervention, door-to-balloon time and mortality for patients with ST-elevation myocardial infarction in England: a registry-based prospective national cohort study. BMJ Qual Saf. 2020 Jul;29(7):541-549. doi: 10.1136/bmjqs-2019-010067. Epub 2019 Dec 12.
- Tamis-Holland JE, Abbott JD, Al-Azizi K, Barman N, Bortnick AE, Cohen MG, Dehghani P, Henry TD, Latif F, Madjid M, Yong CM, Sandoval Y. SCAI Expert Consensus Statement on the Management of Patients With STEMI Referred for Primary PCI. J Soc Cardiovasc Angiogr Interv. 2024 Oct 7;3(11):102294. doi: 10.1016/j.jscai.2024.102294. eCollection 2024 Nov.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- Érrendszeri betegségek
- Szív-és érrendszeri betegségek
- Patológiás folyamatok
- Szívbetegségek
- Infarktus
- Elhalás
- Érelmeszesedés
- Artériás elzáródásos betegségek
- Koszorúér-betegség
- Szívizom ischaemia
- Miokardiális infarktus
- Ischaemia
- Kóros állapotok, jelek és tünetek
- ST Elevációs szívizominfarktus
- A koszorúér-betegség
Egyéb vizsgálati azonosító számok
- On Vs Off PPCI
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
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