Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, 08035, Spain
Location status: Recruiting
Location contact
Jorge Pagola, Neurologist
CONTACT
932746000 ext. 6364
Jorge Pagola, Neurologist
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05565781
Stroke recurrence largely depends on the detection of the cause and the control of vascular risk factors, with occult atrial fibrillation (AF) being one of the most important. Prolonged ambulatory cardiac monitoring is recommended for detecting occult AF. Currently, there are non-invasive monitoring devices such as the textile Holter that have proven to be useful for monitoring for up to 30 days but not longer. Another alternative is smartwatches, although they must be validated for use in the elderly population who have had a stroke.
Interested in participating?
Request Info55 year and older
All sexes
Interventional
Not applicable
Barcelona, Catalonia, 08035, Spain
Location status: Recruiting
Jorge Pagola, Neurologist
CONTACT
932746000 ext. 6364
Jorge Pagola, Neurologist
PRINCIPAL_INVESTIGATOR
The primary objective is to demonstrate that the protocol of ambulatory cardiac monitoring with wearable devices for 12 months allows detection of a higher percentage of occult AF than monitoring for 30 days. The secondary objectives will be to demonstrate the internal validity of smartwatches against insertable cardiac recorders for the detection of AF. To evaluate the usability and adherence to the use of smartwatches in patients with stroke. Detect predictors that can help detect long-term occult AF. Determine the profile of vascular events in each group. Detect predictors of vascular recurrence defined as stroke recurrence, incidence of cerebral hemorrhage, heart failure, myocardial infarction or vascular death.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Testing ECG smartwatch to detect AF or potential signs of AF
Gold-standard cardiac monitor for comparison of testing device (ECG smartwatch)
Regular cardiac monitor for diagnosis of AF
Time frame: Assessed throughout 1 year trial period
To identify and compare prevalence rates of AF detection for the purpose of determine the clinical relevance or not of a prolonged screening process for AF. On the intervention group, patients will have a cardiac monitoring for up to 12 months. If AF is detected by ECG smartwatch, the ICM data will be analyzed by a cardiologist team and provide an ECG report to investigators in order to confirmed ECG smartwatch result.
Time frame: Assessed throughout 1 year trial period
Episodes of atrial fibrillation detected by the ECG smartwatch will be compared to the gold-standard cardiac monitor
Time frame: Assessed throughout 1 year trial period
To evaluate the usability to the use of the ECG Smartwatch through the System usability scale (SUS) and self-reported of likes or dislikes encountered with wearable.
Time frame: Assessed at the end of the 1 and 2 year trial period
To describe and compare the percentage of adequate control of VRFs among patients in each study group. VRFs metrics are defined according to the American Heart Association's recommendations, including blood pressure, lipids, glucose, body mass index, nicotine exposure, diet, physical activity, and sleep health. Sub-study analysis will be perform considering data from smartwatch such as sleep, physical activity, and other health behavior.
Time frame: Assessed at the end of the 1 and 2 year trial period
To describe the vascular events defined as recurrence of stroke, the incidence of cerebral hemorrhage, heart failure, myocardial infarction, or vascular death in each study group
Time frame: Assessed at the end of the 1 and 2 year trial period
To identify predictors of vascular recurrence (recurrent stroke, cerebral hemorrhage, heart failure, myocardial infarction, or vascular death) in each study group. Predictors of vascular recurrence included sociodemographic data such as age, sex and education level; BMI (kg/m2); history of diabetes mellitus; LDL-cholesterol and medications, such as the use of anti-hypertensive medications, lipid-lowering medications, and antiplatelet therapy. Also clinical symptoms, neuroimagen and ECG parameters will be included in the analysis.
Hospital Universitari Vall d'Hebron Research Institute
Other
Impact of Non-invasive Remote Monitoring Via Wearable Technologies for Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke
Acronym: SMARTTHUNDER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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