Different Reperfusion Timing and Ventricular Arrhythmias in STEMI Patients

NCT04660474 | Completed

• 1 other identifier: VERY-STEMI
• Study Type: observational
• Target: 517
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• VAs

  The incidence of ventricular arrhythmias on 24h-dynamic electrocardiogram.

  12 months

Secondary Outcomes (4)

• Death from coronary heart disease

  12 months

• Fetal of non-fetal ischemic stroke

  12 months

• Revascularization

  12 months

• Chest pain requiring readmission

  12 months

Study Arms (3)

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.

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.

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• The Affiliated Jiangning Hospital of Nanjing Medical University: collaborator
• The Affiliated Hospital of Hangzhou Normal University: collaborator
• Huai'an First People's Hospital: collaborator

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Related Publications (7)

• 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.

  PMID: 28886621 BACKGROUND

• 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.

  PMID: 18415952 BACKGROUND

• 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.

  PMID: 17105759 BACKGROUND

• 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.

  PMID: 24297771 BACKGROUND

• 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.

  PMID: 11526353 BACKGROUND

• 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.

  PMID: 10871162 BACKGROUND

• 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.

  PMID: 21062997 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Liansheng Wang, Doctor

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 9, 2020
• Study Start: July 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)