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

Acute Myocardial Infarction Clinical Trial

Official title:

The Impacts of Different Stent Types in Acute Myocardial Infarction on the Risk of Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03382990
• Other study ID #: Stent-AF Trial
• Status: Not yet recruiting
• Phase: N/A
• First received: December 19, 2017
• Last updated: December 19, 2017
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2017
• Source: Mackay Memorial Hospital
• Contact: Chao-Feng Lin, MD
• Phone: +886-2-2543-3535
• Email: thcpci[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40000
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Atrial Fibrillation
• Atrial Fibrillation New Onset
• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	new-onset atrial fibrillation	new record or diagnostic claims of atrial fibrillation after hospital discharge from acute myocardial infarction	one year