Different Reperfusion Timing and Ventricular Arrhythmias in STEMI Patients

NCT ID: NCT04660474

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 517 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2022-12-31

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.

Conditions

ST Elevation Myocardial Infarction; Arrhythmia Ventricular

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early reperfusion group

All patients hospitalized and diagnosed as STEMI according to the 4th universal definition of myocardial infarction underwent coronary angiography and PCI treatment. Patients with SO2RT\<24 hours were assigned to Early reperfusion group.

No interventions assigned to this group

Intermediate reperfusion group

All patients hospitalized and diagnosed as STEMI according to the 4th universal definition of myocardial infarction underwent coronary angiography and PCI treatment. Patients with SO2RT ranging from 24 hours to 7days were assigned to Intermediate reperfusion group.

No interventions assigned to this group

Late reperfusion group

All patients hospitalized and diagnosed as STEMI according to the 4th universal definition of myocardial infarction underwent coronary angiography and PCI treatment. Patients with SO2RT\>7days were assigned to Late reperfusion group.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Jiangning Hospital of Nanjing Medical University

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Hangzhou Normal University

OTHER

Sponsor Role: collaborator

Huai'an First People's Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liansheng Wang, Doctor

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Locations

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 28886621 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18415952 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17105759 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24297771 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11526353 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10871162 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21062997 (View on PubMed)

Other Identifiers

VERY-STEMI

Identifier Type: -

Identifier Source: org_study_id