The main objective of this study is to compare the incidence of detected AF in cryptogenic stroke patients by the AliveCor with the incidence of detected AF by a 7-Day Holter ECG.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint will be the percentage of detected atrial fibrillation in
both the AliveCor group and the 7-Day Holter group after one year.
Secondary outcome
- Pro-BNP levels in all patients within 24 hours after cryptogenic stroke
- Percentages of atrial ectopy detected on the 7-day Holter monitor
- Left atrial diameter and volume
- Recurrent stroke
- Major bleeding
Background summary
A standard work-up of stroke patients to identify a cause of stroke consists of
Computed Tomography (CT), CT angiography of head and neck arteries,
transthoracic echocardiography, 12-lead 10-seconds electrocardiogram (ECG),
blood tests and 24-hour ECG monitoring. A stroke is called *cryptogenic* if no
cause can be determined after standard work-up. Current detection of atrial
fibrillation (AF) after stroke is 2.0%. The detection of AF is extremely
important because adequate detection and subsequent treatment can prevent
recurrent stroke. Recent studies revealed that prolonged monitoring yields
higher percentages of detected AF (12.0%). Devices used in these trials suffer
from drawbacks. Our hypothesis is that a new, smartphone compatible device,
producing a single lead ECG (AliveCor), can be used for prolonged ECG
monitoring in cryptogenic stroke patients.
Study objective
The main objective of this study is to compare the incidence of detected AF in
cryptogenic stroke patients by the AliveCor with the incidence of detected AF
by a 7-Day Holter ECG.
Study design
A multicenter randomized trial.
Intervention
After inclusion, patients will be randomized to either the AliveCor or a 7-Day
Holter Monitor.
Study burden and risks
Both devices are battery powered and electrically safe. Patients face a 2-3%
risk that AF is detected false-positively; this might lead to incorrect oral
anticoagulation (OAC) prescription. However, a potential benefit of our stuy is
that if AF is detected and treated with OAC, this significantly reduces the
chance of recurrent stroke.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Patient with cryptogenic stroke
Patient with cryptogenic TIA
Exclusion criteria
- Known etiology of TIA or stroke
- Myocardial infarction <6 months before stroke
- Coronary Artery Bypass Grafting <6 months before stroke
- Severe valvular heart disease
- Documented history of atrial fibrillation or atrial flutter
- Permanent indication for oral anticoagulation at enrolment
- Patient has permanent OAC contraindication
- Patient is included in another randomized trial
- Left ventricular aneurysm on echocardiography
- Thrombus on echocardiographyRenal dysfunction (creatinine clearance <30 mL/min/1.73m2)
- Patient has life expectancy of <1 year
- Patient is not willing to sign the informed consent form
- Patient is <18 years of age
- Patient is considered a incapacitated adult
- Patient is not in possession of a smartphone with Android Operating System (OS) or iOS.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02507986 |
| CCMO | NL54103.058.15 |