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Stent Placement and the Risk of New-onset AF in Patients With AMI

NCT ID: NCT03382990

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-12-31

Brief Summary

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The benefit of a drug-eluting stent (DES) in patients with acute myocardial infarction (AMI) is controversial. This study will aim to observe the effect of a DES on the risk of new-onset AF in patients with AMI.

Detailed Description

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Acute myocardial infarction (AMI) is the leading cause of mortality in the world. Early invasive strategy with percutaneous coronary intervention (PCI) has been demonstrated to be the most effective strategy to treat AMI. Although drug-eluting stent (DES) has not shown benefits to reduce mortality rate among AMI patients compared with bare-metal stent (BMS), the use of DES in real-world is increasing because of reduced restenosis rates. AMI patients are at higher risk to develop atrial fibrillation (AF) than general population. However, whether early PCI with DES implantation is related to a reduced risk of AF still remains unclear. The purpose of this study is to investigate the association of DES implantation and the risk of AF among patients with AMI treated by early PCI.

Conditions

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Atrial Fibrillation New Onset Acute Myocardial Infarction

Keywords

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Atrial fibrillation Acute myocardial infarction Drug-eluting stent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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STEMI

Patients with STEMI treated with PCI and stent placement (DES or BMS)

DES or BMS

Intervention Type DEVICE

DES or BMS placement during the procedure of PCI in patients with AMI is depend on the operator's decision.

NSTEMI

Patients with NSTEMI treated with PCI and stent placement (DES or BMS)

DES or BMS

Intervention Type DEVICE

DES or BMS placement during the procedure of PCI in patients with AMI is depend on the operator's decision.

Interventions

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DES or BMS

DES or BMS placement during the procedure of PCI in patients with AMI is depend on the operator's decision.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients were enrolled by primary diagnostic coding as acute myocardial infarction and treatment coding as receiving PCI between 2007 and 2013 in Taiwan National Health Insurance Research Database (NHIRD)

Exclusion Criteria

1. Less than 20-years-old; Unknown sex and age
2. Not residents in Taiwan
3. Died during AMI admission
4. Previous history of AF
5. Receiving coronary artery bypass grafting (CABG), ventricular assist device (VAD), extracorporeal membrane oxygenation (ECMO), and heart transplantation during observational and/or database period
6. No stent implantation during PCI
7. Unknown stent types
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mackay Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li-Nien Chien, PhD

Role: STUDY_CHAIR

Taipei Medical University

Central Contacts

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Chao-Feng Lin, MD

Role: CONTACT

Phone: +886-2-2543-3535

Email: [email protected]

Li-Nien Chien, PhD

Role: CONTACT

Phone: +886-2-6638-2736

Email: [email protected]

Other Identifiers

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Stent-AF Trial

Identifier Type: -

Identifier Source: org_study_id