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

NCT03382990 | Unknown FDA Device

• 1 other identifier: Stent-AF Trial
• Study Type: observational
• Target: 40,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atrial Fibrillation New Onset; Acute Myocardial Infarction

Keywords

Atrial fibrillation; Acute myocardial infarction; Drug-eluting stent

Outcome Measures

Primary Outcomes (1)

• new-onset atrial fibrillation

  new record or diagnostic claims of atrial fibrillation after hospital discharge from acute myocardial infarction

  one year

Study Arms (2)

STEMI

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

Device: DES or BMS

NSTEMI

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

Device: DES or BMS

Interventions

DES or BMS DEVICE

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

NSTEMI; STEMI

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Within the retrospective cohort, we include patients who had received a primary diagnosis of AMI based on the discharge claim between 2007 and 2013. After the exclusion by the mentioned criteria, patients with AMI treated with PCI and stent placement are intended to be analyzed in the present study.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Li-Nien Chien, PhD

  Taipei Medical University

  STUDY CHAIR

Central Study Contacts

Chao-Feng Lin, MD

CONTACT

+886-2-2543-3535; thcpci@gmail.com

Li-Nien Chien, PhD

CONTACT

+886-2-6638-2736; lnchien@tmu.edu.tw

Study Design

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

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 26, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: December 26, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share