Clinical trial NCT04660474: Different Reperfusion Timing and Ventricular Arrhythmias in STEMI Patients
Official title: Association of Reperfusion Timing With Short- and Medium-term Ventricular Arrhythmias in Patients With ST-segment Elevation Myocardial Infarction: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST Elevation Myocardial Infarction
Arrhythmia Ventricular
Keywords: Symptom Onset-to-Reperfusion Timing (SO2RT)
ST Elevation Myocardial Infarction
Arrhythmia Ventricular
Percutaneous Coronary Intervention
Early Reperfusion
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: The Affiliated Jiangning Hospital of Nanjing Medical University
name: The Affiliated Hospital of Hangzhou Normal University
name: Huai'an First People's Hospital
First posted: 2020-12-09
Enrollment: 517
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A prospective cohort study was designed to investigate the effects of different reperfusion timing on VAs in STEMI patients. During the patients' follow-up, 24h-dynamic electrocardiography, echocardiography were required to record the incidence of primary outcome and other parameters. Information on SO2RT, demographic characteristics, hypertension, diabetes and dyslipidemia history, drug use, smoking, drinking, biochemical indexes and coronary lesions were also collected.

Brief summary: The aim of this study was to investigate the association between different reperfusion timing and ventricular arrhythmias (VAs) to provide evidence for clinical decision-making for patients with ST-segment elevation myocardial infarction (STEMI). All the participants included in the study were diagnosed with STEMI according to the 4th universal definition of myocardial infarction, with a follow-up of 1, 6, 12 months, respectively. Symptom onset-to-reperfusion timing (SO2RT) and 24h-dynamic electrocardiogram parameters were recorded to compare different SO2RT and VAs during 3 follow-up visits.

Detailed description: It is Class I recommendation that STEMI require emergency revascularization with no delay. However, arrhythmias after acute myocardial infarction (AMI), particularly VAs, also occur in the early post-MI phase, leading to increased mortality. Previous studies have shown benefits of late reperfusion to electrical stability. The aim of this study was to investigate the association between different reperfusion timing and VAs to provide evidence for clinical decision-making for STEMI. In this multicenter, prospective, observational study, STEMI participants from July 2019 to December 2020 confirmed according to the 4th universal definition of myocardial infarction were enrolled, with a follow-up of 1, 6, 12 months, respectively. SO2RT was defined as the time interval between symptom onset and reperfusion timing which referred to the timing when coronary angiography showed Thrombolysis In Myocardial Infarction (TIMI) blood flow level 2\~3 immediately after percutaneous coronary intervention (PCI). The primary end point was VAs on 24h-dynamic electrocardiogram. Secondary outcomes included a composite of death from coronary heart disease, fetal of non-fetal ischemic stroke, revascularization, or chest pain requiring readmission.

Eligibility criteria: Inclusion Criteria:

* STEMI patients undergoing coronary angiography and PCI;
* can complete 3 follow-up visits well.

Exclusion Criteria:

* without PCI;
* undergoing thrombolytic therapy;
* mental diseases;
* renal failure;
* stroke sequelae;
* tumor and a history of revascularization.

Primary outcomes:
measure: VAs
timeFrame: 12 months
Secondary outcomes:
measure: Death from coronary heart disease
timeFrame: 12 months
measure: Fetal of non-fetal ischemic stroke
timeFrame: 12 months
measure: Revascularization
timeFrame: 12 months
measure: Chest pain requiring readmission
timeFrame: 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Liansheng Wang, Doctor
role: STUDY_DIRECTOR
References:
citation: Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
citation: Appleton DL, Abbate A, Biondi-Zoccai GG. Late percutaneous coronary intervention for the totally occluded infarct-related artery: a meta-analysis of the effects on cardiac function and remodeling. Catheter Cardiovasc Interv. 2008 May 1;71(6):772-81. doi: 10.1002/ccd.21468.
citation: Hochman JS, Lamas GA, Buller CE, Dzavik V, Reynolds HR, Abramsky SJ, Forman S, Ruzyllo W, Maggioni AP, White H, Sadowski Z, Carvalho AC, Rankin JM, Renkin JP, Steg PG, Mascette AM, Sopko G, Pfisterer ME, Leor J, Fridrich V, Mark DB, Knatterud GL; Occluded Artery Trial Investigators. Coronary intervention for persistent occlusion after myocardial infarction. N Engl J Med. 2006 Dec 7;355(23):2395-407. doi: 10.1056/NEJMoa066139. Epub 2006 Nov 14.
citation: Malek LA, Silva JC, Bellenger NG, Nicolau JC, Klopotowski M, Spiewak M, Rassi CH, Lewandowski Z, Kruk M, Rochitte CE, Ruzyllo W, Witkowski A. Late percutaneous coronary intervention for an occluded infarct-related artery in patients with preserved infarct zone viability: a pooled analysis of cardiovascular magnetic resonance studies. Cardiol J. 2013;20(5):552-9. doi: 10.5603/CJ.2013.0141.
citation: Sadanandan S, Buller C, Menon V, Dzavik V, Terrin M, Thompson B, Lamas G, Hochman JS. The late open artery hypothesis--a decade later. Am Heart J. 2001 Sep;142(3):411-21. doi: 10.1067/mhj.2001.117774.
citation: Sadanandan S, Hochman JS. Early reperfusion, late reperfusion, and the open artery hypothesis: an overview. Prog Cardiovasc Dis. 2000 May-Jun;42(6):397-404.
citation: Steigen TK, Buller CE, Mancini GB, Jorapur V, Cantor WJ, Rankin JM, Thomas B, Webb JG, Kronsberg SS, Atchison DJ, Lamas GA, Hochman JS, Dzavik V. Myocardial perfusion grade after late infarct artery recanalization is associated with global and regional left ventricular function at one year: analysis from the Total Occlusion Study of Canada-2. Circ Cardiovasc Interv. 2010 Dec;3(6):549-55. doi: 10.1161/CIRCINTERVENTIONS.109.918722. Epub 2010 Nov 9.