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Smartwatch and External Holter Monitoring to Detect Atrial Fibrillation in Patients With Cryptogenic Stroke (SMARTTHUNDER)

Primary Purpose

Paroxysmal Atrial Fibrillation, Cryptogenic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ECG smartwatch
Insertable Cardiac Monitor (ICM)
External ECG Monitoring
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Paroxysmal Atrial Fibrillation focused on measuring Wearable Electronic Devices

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age greater to or equal to 55 years
  • Patients with diagnosis of cryptogenic stroke after a basic study that included neuroimaging, extra/intracranial vascular evaluation, 24-hour monitoring, and echocardiogram
  • Patients with acute cortical infarction with the presence of intracranial occlusion (preferably)
  • Modified Rankin Scale (mRS) lower to 4

Exclusion Criteria:

  • Diagnosis of lacunar infarction or transient ischemic attack (TIA)
  • Diagnosis of stroke of known source: atherothrombotic due to moderate or severe symptomatic extra/intracranial stenosis, major cardioembolic cause (atrial fibrillation, anterior or apical ventricular akinesis, causal PFO, post-AMI, flutter or mitral stenosis), unusual cause (thrombophilia, arterial dissection symptomatic, toxic)
  • Use of pacemakers
  • Circumstances that may preclude the clinical follow-up or reduce the possibilities of obtaining data to achieve the objectives of the study and/or limit contact with the investigator (for example, transfer to a social health center)
  • Unwillingness to the use of cardiac monitoring wearable devices
  • Not understanding study procedures

Sites / Locations

  • Hospital Universitari Vall d'HebronRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

ECG Smartwatch for up to 1 year

Holter monitoring for up to 1 year

Control group

Arm Description

Cardiac monitoring with an ECG Smartwatch over 1 year after the acute phase of cryptogenic stroke. Simultaneously, a continuous cardiac monitoring will be performed using an Insertable Cardiac Monitor (ICM)

Cardiac monitoring with an external holter device for 30 days after the acute phase of cryptogenic stroke and 15 additional days of extended use every 3 months up to 1 year

Regular cardiac monitoring with an external holter device for 30 days after the acute phase of cryptogenic stroke

Outcomes

Primary Outcome Measures

Increased probability of detecting AF
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.

Secondary Outcome Measures

Identification of Atrial Fibrillation using a ECG smartwatch
Episodes of atrial fibrillation detected by the ECG smartwatch will be compared to the gold-standard cardiac monitor
Usability and adherence to ECG Smartwatch
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.
Control of vascular risk factors (VRF)
To describe and compare the percentage of adequate control of VRFs among patients in each study group. VRFs metrics are defined according to the AHA Life Simple 7 factors. Ideal metrics were defined as follows: (1) Smoking status: never or former smoker; (2) BMI: <25 kg/m2; (3) Physical activity: ≥150 min/wk of moderate-intensity physical activity; (4) Healthy diet: 4 or 5 fruits/vegetables per day; (5) Total cholesterol <200 mg/dL; (6) Blood pressure <120/80 mm Hg; (7) Fasting glucose <100 mg/dL.
Vascular events incidence
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
Predictors of vascular recurrence
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.

Full Information

First Posted
September 21, 2022
Last Updated
September 30, 2022
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05565781
Brief Title
Smartwatch and External Holter Monitoring to Detect Atrial Fibrillation in Patients With Cryptogenic Stroke
Acronym
SMARTTHUNDER
Official Title
Impact of Non-invasive Remote Monitoring Via Wearable Technologies for Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Cryptogenic Stroke
Keywords
Wearable Electronic Devices

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ECG Smartwatch for up to 1 year
Arm Type
Active Comparator
Arm Description
Cardiac monitoring with an ECG Smartwatch over 1 year after the acute phase of cryptogenic stroke. Simultaneously, a continuous cardiac monitoring will be performed using an Insertable Cardiac Monitor (ICM)
Arm Title
Holter monitoring for up to 1 year
Arm Type
Active Comparator
Arm Description
Cardiac monitoring with an external holter device for 30 days after the acute phase of cryptogenic stroke and 15 additional days of extended use every 3 months up to 1 year
Arm Title
Control group
Arm Type
Other
Arm Description
Regular cardiac monitoring with an external holter device for 30 days after the acute phase of cryptogenic stroke
Intervention Type
Device
Intervention Name(s)
ECG smartwatch
Intervention Description
Testing ECG smartwatch
Intervention Type
Device
Intervention Name(s)
Insertable Cardiac Monitor (ICM)
Intervention Description
Gold-standard cardiac monitor for comparison of testing device (ECG smartwatch)
Intervention Type
Device
Intervention Name(s)
External ECG Monitoring
Intervention Description
Regular cardiac monitor for diagnosis of atrial fibrillation
Primary Outcome Measure Information:
Title
Increased probability of detecting AF
Description
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
Secondary Outcome Measure Information:
Title
Identification of Atrial Fibrillation using a ECG smartwatch
Description
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
Title
Usability and adherence to ECG Smartwatch
Description
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 throughout 1 year trial period
Title
Control of vascular risk factors (VRF)
Description
To describe and compare the percentage of adequate control of VRFs among patients in each study group. VRFs metrics are defined according to the AHA Life Simple 7 factors. Ideal metrics were defined as follows: (1) Smoking status: never or former smoker; (2) BMI: <25 kg/m2; (3) Physical activity: ≥150 min/wk of moderate-intensity physical activity; (4) Healthy diet: 4 or 5 fruits/vegetables per day; (5) Total cholesterol <200 mg/dL; (6) Blood pressure <120/80 mm Hg; (7) Fasting glucose <100 mg/dL.
Time Frame
Assessed at the end of the 1 and 2 year trial period
Title
Vascular events incidence
Description
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
Title
Predictors of vascular recurrence
Description
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.
Time Frame
Assessed at the end of the 1 and 2 year trial period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater to or equal to 55 years Patients with diagnosis of cryptogenic stroke after a basic study that included neuroimaging, extra/intracranial vascular evaluation, 24-hour monitoring, and echocardiogram Patients with acute cortical infarction with the presence of intracranial occlusion (preferably) Modified Rankin Scale (mRS) lower to 4 Exclusion Criteria: Diagnosis of lacunar infarction or transient ischemic attack (TIA) Diagnosis of stroke of known source: atherothrombotic due to moderate or severe symptomatic extra/intracranial stenosis, major cardioembolic cause (atrial fibrillation, anterior or apical ventricular akinesis, causal PFO, post-AMI, flutter or mitral stenosis), unusual cause (thrombophilia, arterial dissection symptomatic, toxic) Use of pacemakers Circumstances that may preclude the clinical follow-up or reduce the possibilities of obtaining data to achieve the objectives of the study and/or limit contact with the investigator (for example, transfer to a social health center) Unwillingness to the use of cardiac monitoring wearable devices Not understanding study procedures
Facility Information:
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Pagola, Neurologist
Phone
932746000
Ext
6364
Email
jpagola@vhebron.net
First Name & Middle Initial & Last Name & Degree
Jorge Pagola, Neurologist

12. IPD Sharing Statement

Plan to Share IPD
No

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Smartwatch and External Holter Monitoring to Detect Atrial Fibrillation in Patients With Cryptogenic Stroke

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