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

December 19, 2017 updated by: Mackay Memorial Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

40000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
STEMI
Patients with STEMI treated with PCI and stent placement (DES or BMS)
Device: DES or BMS
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)
Device: DES or BMS
DES or BMS placement during the procedure of PCI in patients with AMI is depend on the operator's decision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
new-onset atrial fibrillation
Time Frame: one year
new record or diagnostic claims of atrial fibrillation after hospital discharge from acute myocardial infarction
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mackay Memorial Hospital

Investigators

  • Study Chair: Li-Nien Chien, PhD, Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Actual)

December 26, 2017

Last Update Submitted That Met QC Criteria

December 19, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stent-AF Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myocardial Infarction

Clinical Trials on DES or BMS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe