Atrial Fibrillation Clinical Trial
Official title:
Systematic Screening for Atrial Fibrillation-potential Patients to Increase AF Detection Rate (SCAN-AF)
NCT number | NCT03313167 |
Other study ID # | CV185-595 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 29, 2017 |
Est. completion date | May 23, 2019 |
Verified date | August 2019 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To assess the prevalence of all (prevalent and paroxysmal) undiagnosed atrial fibrillation (AF) in a Japanese population with a moderate-to-high risk of stroke
Status | Completed |
Enrollment | 1316 |
Est. completion date | May 23, 2019 |
Est. primary completion date | May 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Age = 65 and one or more of the following: hypertension, prior stroke or transient ischemic attack, congestive heart failure, diabetes mellitus, and/or vascular disease Exclusion Criteria: - Age < 65 years, individuals with AF or a history of AF, or individuals taking anti-arrhythmic drugs Other protocol defined inclusion/exclusion criteria could apply |
Country | Name | City | State |
---|---|---|---|
Japan | Local Institution | Itabashi-ku | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of subjects screened with AF identified at Index Visit | Up to 4 weeks | ||
Primary | number of subjects screened with AF not identified at Index Visit | number of subjects screened who have AF not identified at their Index Visit but subsequently found to have AF confirmed by 12-lead Electrocardiogram (ECG) during the extended monitoring period | Up to 4 weeks from Index Visit | |
Secondary | number of subjects with ECG-confirmed AF detected by the Omron BP device | number of subjects with ECG-confirmed AF detected by the Omron blood pressure (BP) device during the extended monitoring period | Day 1 to Day 14 | |
Secondary | number of subjects with ECG-confirmed AF detected by MB or HCG-801 | number of subjects with ECG-confirmed AF detected by MyBeat (MB) or Omron HeartScan 801 (HCG-801) during the extended monitoring period | Day 14 to Day 28 | |
Secondary | number of subjects with AF identified at Index Visit who are prescribed guideline recommended anticoagulation therapy | 24 week follow up period | ||
Secondary | number of subjects with AF identified at their Index Visit who are prescribed guideline recommended anticoagulation therapy and still on the prescribed anticoagulation therapy at the end of the 24-week follow-up period | At week 24 | ||
Secondary | number of subjects with Paroxysmal atrial fibrillation (PAF) identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy | Day 1 to Day 28 | ||
Secondary | number of subjects with PAF identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy and still on the prescribed anticoagulation therapy at the end of the 24-week follow-up | At week 24 | ||
Secondary | number of subjects with AF identified at the Index Visit who had an ischemic stroke during the 24-week follow-up period | Index Visit up to week 24 | ||
Secondary | number of subjects with PAF identified during the extended monitoring period who had an ischemic stroke during the 24-week follow-up period | Day 1 up to week 24 | ||
Secondary | number of subjects with AF identified at the Index Visit who bled during the 24-week follow-up period | Index Visit up to week 24 | ||
Secondary | number of subjects with PAF identified during the extended monitoring period who bled during the 24-week follow-up period | Day 1 up to week 24 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
Completed |
NCT04571385 -
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
|
Phase 2 | |
Completed |
NCT05366803 -
Women's Health Initiative Silent Atrial Fibrillation Recording Study
|
N/A | |
Completed |
NCT02864758 -
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
|
||
Recruiting |
NCT05442203 -
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
|
N/A | |
Completed |
NCT05599308 -
Evaluation of Blood Pressure Monitor With AFib Screening Feature
|
N/A | |
Completed |
NCT03790917 -
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
|
||
Enrolling by invitation |
NCT05890274 -
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
|
N/A | |
Recruiting |
NCT05316870 -
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
|
N/A | |
Recruiting |
NCT05266144 -
Atrial Fibrillation Patients Treated With Catheter Ablation
|
||
Not yet recruiting |
NCT06023784 -
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
Completed |
NCT04087122 -
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
|
N/A | |
Completed |
NCT06283654 -
Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
|
||
Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|
||
Completed |
NCT04546763 -
Study Watch AF Detection At Home
|
||
Completed |
NCT03761394 -
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
|
N/A |