Atrial Fibrillation New OnsetNCT03382990
Stent Placement and the Risk of New-onset AF in Patients With AMI
An observational study of Atrial Fibrillation New Onset and Acute Myocardial Infarction, run by Mackay Memorial Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset, Acute Myocardial Infarction
- What is being tested?
- DES or BMS
- Type of treatment
- Medical device
- How many people
- 40,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- DES or BMS
- Keywords
- Atrial fibrillation, Acute myocardial infarction, Drug-eluting stent
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DES or BMSDevice
DES or BMS placement during the procedure of PCI in patients with AMI is depend on the operator's decision.
| Study group | Role | What they receive |
|---|---|---|
| STEMI | Patients with STEMI treated with PCI and stent placement (DES or BMS) Receives: Device: DES or BMS | |
| NSTEMI | Patients with NSTEMI treated with PCI and stent placement (DES or BMS) Receives: Device: DES or BMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
new-onset atrial fibrillation
new record or diagnostic claims of atrial fibrillation after hospital discharge from acute myocardial infarction
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation New OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Nien Chien, PhD, Study chair, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382990
- Sponsor's protocol ID
- Stent-AF Trial
- Status last verified
- Dec 2017
- First submitted
- 19 Dec 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impacts of Different Stent Types in Acute Myocardial Infarction on the Risk of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03382990
- Acronym / sponsor ID
- Stent-AF Trial
- Keywords
- Atrial fibrillation, Acute myocardial infarction, Drug-eluting stent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEMI | – | Device: DES or BMSPatients with STEMI treated with PCI and stent placement (DES or BMS) |
| NSTEMI | – | Device: DES or BMSPatients with NSTEMI treated with PCI and stent placement (DES or BMS) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DES or BMSDES or BMS placement during the procedure of PCI in patients with AMI is depend on the operator's decision. | Device | NSTEMI, STEMI |
Primary outcome
new-onset atrial fibrillation
Time frame: one year
new record or diagnostic claims of atrial fibrillation after hospital discharge from acute myocardial infarction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Nien Chien, PhD study chair
Taipei Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation New Onset and Acute Myocardial Infarction, run by Mackay Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao-Feng Lin, MD (+886-2-2543-3535, thcpci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
new-onset atrial fibrillation (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.