StrokeEDUCATE-ESUSNCT02801708
Enhanced Detection of Underlying, Covert ATrial Fibrillation Using 7-day Holter Electrocardiogram in Patients With Embolic Stroke of Undetermined Source
An observational study of Stroke, run by National Cerebral and Cardiovascular Center, Japan at 1 site in Japan.
Trial summary
The aim of this study is to determine the diagnostic yield of continuous 7-day Holter ECG for detecting covert paroxysmal atrial fibrillation in patients with recent embolic stroke or transient ischemic attack (TIA) of undetermined cause after completion of a standard clinical work up including an initial 24-hour… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2014to Mar 2019
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with recent embolic stroke of undetermined source
Who may be able to join
- Recent ESUS (within 3 months of onset) defined as:
- Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar B. Abscence of ≥ 50% stenosis or occlusion in cervical and intracranial arteries supplying ischemic area C. No atrial fibrillation after ≥ 24-hour Holter monitoring D. No intra-cardiac thrombus on transthoracic echocardiography E. No other major cardioembolic sources F. No other specific cause of stroke (for example, arteritis, dissection, migraine/vasospasm, drug abuse)
- 20 years of age or older
- Signed written informed consent
Who cannot join
- Previously documented atrial fibrillation
- Untreated hyperthyroidism
- Pacemaker or implantable cardioverter defibrillator implanted or planned to implant
- Estimated life expectancy < 12 months
- Examination of seven-day Holter ECG not applicable within 3 months after stroke onset.
- Patients considered inappropriate to participate in the study
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
National Cerebral and Cardiovascular Center
Suita, Osaka, 565-8565
Yuichi Miyazaki, MD, 81-6-6833-5012, ymiyazaki@ncvc.go.jp
Kazunori Toyoda, MD, PhD, 81-6-6833-5012, toyoda@ncvc.go.jp
About this study
The aim of this study is to determine the diagnostic yield of continuous 7-day Holter ECG for detecting covert paroxysmal atrial fibrillation in patients with recent embolic stroke or transient ischemic attack (TIA) of undetermined cause after completion of a standard clinical work up including an initial 24-hour Holter monitoring.
Read the detailed description
Covert atrial fibrillation (AF) is a relevant potential cause of a recently proposed clinical construct, "Embolic Stroke of Undetermined Source (ESUS)". However, routine post-stroke work up including 24-hour Holter monitoring may fail to detect paroxysmal AF. A recent systematic review has shown an increased AF detection rate with longer monitoring durations. The aim of this study is to evaluate the effectiveness of a novel ambulatory 7-day Holter ECG (EV-201, Parama-Tech inc.) for detecting AF in patients with recent ESUS after completion of a standard clinical examination.
- Conditions
- Stroke
- Keywords
- Embolic stroke of undetermined source, Atrial fibrillation
- Medical subject headings
- Stroke, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of any atrial fibrillation
Measured: After examination of 7-day Holter monitoring (within 90 days of stroke onset)
Secondary outcomes (5)
Change of antithrombotic drugs
Measured: After the examination of 7-day Holter monitoring
Any ischemic or hemorrhagic event
Measured: 365 days after index stroke
Any adverse event related to 7-day Holter monitoring
Measured: After the examination of 7-day Holter monitoring
Time to detection of atrial fibrillation on 7-day Holter monitoring
Measured: After the examination of 7-day Holter monitoring
Atrial fibrillation burden
defined as the total time in atrial fibrillation devided by the total monitored time
Measured: After the examination of 7-day Holter monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startAug 2014
- Primary completionMar 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cerebral and Cardiovascular Center, Japan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuichi Miyazaki, National Cerebral and Cardiovascular Center, Japan
- Investigators
- Yuichi Miyazaki, MD, Principal investigator, National Cerebral and Cardiovascular Center, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801708
- Sponsor's protocol ID
- NCVC-M27-017
- Acronym
- EDUCATE-ESUS
- Status last verified
- Dec 2016
- First submitted
- 4 Jun 2016
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Miyazaki Y, Toyoda K, Iguchi Y, Hirano T, Metoki N, Tomoda M, Shiozawa M, Koge J, Okada Y, Terasawa Y, Kikuno M, Okano H, Hagii J, Nakajima M, Komatsu T, Yasaka M. Atrial Fibrillation After Ischemic Stroke Detected by Chest Strap-Style 7-Day Holter Monitoring and the Risk Predictors: EDUCATE-ESUS. J Atheroscler Thromb. 2021 May 1;28(5):544-554. doi: 10.5551/jat.58420. Epub 2020 Aug 15.
PubMed 32801289
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Detection of Underlying, Covert ATrial Fibrillation Using 7-day Holter Electrocardiogram in Patients With Embolic Stroke of Undetermined Source
- ClinicalTrials.gov ID
- NCT02801708
- Acronym / sponsor ID
- EDUCATE-ESUS / NCVC-M27-017
- Conditions
- Stroke
- Keywords
- Embolic stroke of undetermined source, Atrial fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Cerebral and Cardiovascular Center, JapanUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 16 Jun 2016 (estimated)
- 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.
The aim of this study is to determine the diagnostic yield of continuous 7-day Holter ECG for detecting covert paroxysmal atrial fibrillation in patients with recent embolic stroke or transient ischemic attack (TIA) of undetermined cause after completion of a standard clinical work up including an initial 24-hour Holter monitoring.
Detailed description
Covert atrial fibrillation (AF) is a relevant potential cause of a recently proposed clinical construct, "Embolic Stroke of Undetermined Source (ESUS)". However, routine post-stroke work up including 24-hour Holter monitoring may fail to detect paroxysmal AF. A recent systematic review has shown an increased AF detection rate with longer monitoring durations. The aim of this study is to evaluate the effectiveness of a novel ambulatory 7-day Holter ECG (EV-201, Parama-Tech inc.) for detecting AF in patients with recent ESUS after completion of a standard clinical examination.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recent embolic stroke of undetermined source
Key inclusion criteria (4 listed)
- Recent ESUS (within 3 months of onset) defined as:
- 20 years of age or older
- Signed written informed consent
Key exclusion criteria (6 listed)
- Previously documented atrial fibrillation
- Untreated hyperthyroidism
- Pacemaker or implantable cardioverter defibrillator implanted or planned to implant
- Estimated life expectancy < 12 months
- Examination of seven-day Holter ECG not applicable within 3 months after stroke onset.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of any atrial fibrillation
Time frame: After examination of 7-day Holter monitoring (within 90 days of stroke onset)
5 secondary outcomes
Change of antithrombotic drugs
Time frame: After the examination of 7-day Holter monitoring
Any ischemic or hemorrhagic event
Time frame: 365 days after index stroke
Any adverse event related to 7-day Holter monitoring
Time frame: After the examination of 7-day Holter monitoring
Time to detection of atrial fibrillation on 7-day Holter monitoring
Time frame: After the examination of 7-day Holter monitoring
Atrial fibrillation burden
Time frame: After the examination of 7-day Holter monitoring
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- Derived from this study: PubMed 32801289Miyazaki Y, Toyoda K, Iguchi Y, Hirano T, Metoki N, Tomoda M, Shiozawa M, Koge J, Okada Y, Terasawa Y, Kikuno M, Okano H, Hagii J, Nakajima M, Komatsu T, Yasaka M. Atrial Fibrillation After Ischemic Stroke Detected by Chest Strap-Style 7-Day Holter Monitoring and the Risk Predictors: EDUCATE-ESUS. J Atheroscler Thromb. 2021 May 1;28(5):544-554. doi: 10.5551/jat.58420. Epub 2020 Aug 15.
Related trials for Stroke
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
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Yuichi Miyazaki, MD principal investigator
National Cerebral and Cardiovascular Center, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by National Cerebral and Cardiovascular Center, Japan at 1 site in Japan.
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 4 inclusion and 6 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 2 Dec 2016. 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 Japan. 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 Yuichi Miyazaki, MD (81-6-6833-5012, ymiyazaki@ncvc.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of any atrial fibrillation (time frame: After examination of 7-day Holter monitoring (within 90 days of stroke onset)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02801708, which also lists 1 linked publication.
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 2 Dec 2016.