Stroke, IschemicNCT04282993
Wearable Devices for Secondary Prevention of Ischemic Stroke
A study testing Wearable devices for identifying and measuring risk factors for ischemic stroke in people with Stroke, Ischemic and Atrial Fibrillation, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
Ischemic stroke is an important cause of death and disability in Western countries. Different risk factors have been identified such as hypertension, diabetes, dyslipidemia, smoke, atrial fibrillation, obesity, and sedentary. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke, Ischemic, Atrial Fibrillation
- What is being tested?
- Wearable devices for identifying and measuring risk factors for ischemic stroke
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 16 Apr 2019to 30 Jun 2022
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal 50 years
- Recent transient ischemic attack or minor stroke
Who cannot join
- Patients with significant cognitive impairment
- Patients dependent in the instrumental activities of daily life
- Patients not able to respect the frequency of monitoring program
- Patients with history of atrial fibrillation
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Università Campus Bio-Medico di Roma
Roma, RM, 00128
Vincenzo Di Lazzaro, +3906225411220, v.dilazzaro@unicampus.it
About this study
Ischemic stroke is an important cause of death and disability in Western countries. Different risk factors have been identified such as hypertension, diabetes, dyslipidemia, smoke, atrial fibrillation, obesity, and sedentary. The aim of this study is to evaluate the feasibility of an approach based on the use of wearable devices for the identification and reduction of risk factors in patients with previous history of ischemic stroke or transient ischemic attack.
- Conditions
- Stroke, Ischemic, Atrial Fibrillation
- Being tested
- Wearable devices for identifying and measuring risk factors for ischemic stroke, Standard of care monitoring
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable devices for identifying and measuring risk factors for ischemic strokeDevice
Identifying and monitoring cerebrovascular risk factors using wearable devices
Standard of care monitoringOther
Periodical medical examinations
| Study group | Role | What they receive |
|---|---|---|
| Wearable Devices Monitoring | Experimental | Patients will be provided with wearable devices for at-home monitoring heart rhythm and rate, blood pressure, pulse oximetry, quality and quantity of sleep, and pace counting. Receives: Device: Wearable devices for identifying and measuring risk factors for ischemic stroke |
| Standard of Care Monitoring | Active comparator | Patients will be evaluated by periodical clinical visits. Receives: Other: Standard of care monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance of patients to at-home follow-up by means of wearable devices
Number of measurements actually performed in comparison to number of expected measurements
Measured: 1 month
Secondary outcomes (2)
Atrial fibrillation Detection Rate
Percentage of subjects with atrial fibrillation detected within 1 month of follow-up
Measured: 1 month
Prevalence of Recurrent Stroke or Transient Ischemic Attack
Prevalence of subjects with recurrent stroke or Transient Ischemic Attack within 1 month of follow-up
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start16 Apr 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Di Lazzaro Vincenzo, Campus Bio-Medico University
- Investigators
- Vincenzo Di Lazzaro, MD, Principal investigator, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282993
- Sponsor's protocol ID
- AN01
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Devices for Secondary Prevention of Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04282993
- Acronym / sponsor ID
- AN01
- Conditions
- Stroke, Ischemic, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 25 Feb 2020 (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.
Ischemic stroke is an important cause of death and disability in Western countries. Different risk factors have been identified such as hypertension, diabetes, dyslipidemia, smoke, atrial fibrillation, obesity, and sedentary. The aim of this study is to evaluate the feasibility of an approach based on the use of wearable devices for the identification and reduction of risk factors in patients with previous history of ischemic stroke or transient ischemic attack.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wearable Devices Monitoring | Experimental | Device: Wearable devices for identifying and measuring risk factors for ischemic strokePatients will be provided with wearable devices for at-home monitoring heart rhythm and rate, blood pressure, pulse oximetry, quality and quantity of sleep, and pace counting. |
| Standard of Care Monitoring | Active comparator | Other: Standard of care monitoringPatients will be evaluated by periodical clinical visits. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than or equal 50 years
- Recent transient ischemic attack or minor stroke
Key exclusion criteria (4 listed)
- Patients with significant cognitive impairment
- Patients dependent in the instrumental activities of daily life
- Patients not able to respect the frequency of monitoring program
- Patients with history of atrial fibrillation
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 |
|---|---|---|
| Wearable devices for identifying and measuring risk factors for ischemic strokeIdentifying and monitoring cerebrovascular risk factors using wearable devices | Device | Wearable Devices Monitoring |
| Standard of care monitoringPeriodical medical examinations | Other | Standard of Care Monitoring |
Primary outcome
Compliance of patients to at-home follow-up by means of wearable devices
Time frame: 1 month
Number of measurements actually performed in comparison to number of expected measurements
2 secondary outcomes
Atrial fibrillation Detection Rate
Time frame: 1 month
Prevalence of Recurrent Stroke or Transient Ischemic Attack
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Stroke, Ischemic
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
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.
Vincenzo Di Lazzaro, MD principal investigator
Campus Bio-Medico University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable devices for identifying and measuring risk factors for ischemic stroke in people with Stroke, Ischemic and Atrial Fibrillation, run by Campus Bio-Medico University at 1 site in Italy.
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 2 inclusion and 4 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 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Vincenzo Di Lazzaro, MD (+3906225411220, v.dilazzaro@unicampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance of patients to at-home follow-up by means of wearable devices (time frame: 1 month). 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 27 Feb 2020.