Cryptogenic Transient Ischemic Attack and Minor StrokeHOLTER-21JNCT03166969
Predictors of Occult Atrial Fibrillation in 171 Patients With Cryptogenic TIA and Minor Stroke
A study testing Holter 21 days in people with Cryptogenic Transient Ischemic Attack and Minor Stroke, run by Versailles Hospital at 1 site in France.
Trial summary
Retrospective study, single-center, on 171 patients, presented a cryptogenic TIA and Minor stroke. This study objective is to determine profitability of Holter 21 days for screening paroxystic ACFA / flutter in cryptogenic TIA/Minor stroke, and identify the predictive factors of discovery a paroxystic ACFA on Holter… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryptogenic Transient Ischemic Attack and Minor Stroke
- What is being tested?
- Holter 21 days
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2007to Jan 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cryptogenic TIA/Minor stroke
- Age > 18 years
- Medical care in Neuro Vascular Unit of CH Versailles
- Holter 21 days performed
Who cannot join
- ACFA history
- ECG or telemetry who showed ACFA before the Holter initializing
- Carotid Stenosis / symptomatic vertebral
- Arterial dissection
- Prothrombotic state demonstrated by laboratory tests
- Infective endocarditis
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective study, single-center, on 171 patients, presented a cryptogenic TIA and Minor stroke.
This study objective is to determine profitability of Holter 21 days for screening paroxystic ACFA / flutter in cryptogenic TIA/Minor stroke, and identify the predictive factors of discovery a paroxystic ACFA on Holter 21 days. Clinical and échocardiographics factors, and brain imaging (scanner and MRI) will be analyzed.
- Being tested
- Holter 21 days
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter 21 daysProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients taken care in neurovascular unit | Experimental | Not described Receives: Procedure: Holter 21 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of atrial fibrillation detected on long duration ( 21 days) cardiac rythm holter monitoring
Atrial fibrillation >= 30 secondes
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study startFeb 2007
- Primary completionJan 2013
- Study completionJan 2013
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 Cryptogenic Transient Ischemic Attack and Minor 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Fernando PICO, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166969
- Sponsor's protocol ID
- P14/08_HOLTER 21J
- Acronym
- HOLTER-21J
- Status last verified
- May 2017
- First submitted
- 12 Sep 2016
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sudacevschi V, Bertrand C, Chadenat ML, Tarnaud C, Pico F. Predictors of Occult Atrial Fibrillation in One Hundred Seventy-One Patients with Cryptogenic Transient Ischemic Attack and Minor Stroke. J Stroke Cerebrovasc Dis. 2016 Nov;25(11):2673-2677. doi: 10.1016/j.jstrokecerebrovasdis.2016.07.014. Epub 2016 Aug 2.
PubMed 27495831
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Occult Atrial Fibrillation in 171 Patients With Cryptogenic TIA and Minor Stroke
- ClinicalTrials.gov ID
- NCT03166969
- Acronym / sponsor ID
- HOLTER-21J / P14/08_HOLTER 21J
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 May 2017 (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.
Retrospective study, single-center, on 171 patients, presented a cryptogenic TIA and Minor stroke.
This study objective is to determine profitability of Holter 21 days for screening paroxystic ACFA / flutter in cryptogenic TIA/Minor stroke, and identify the predictive factors of discovery a paroxystic ACFA on Holter 21 days. Clinical and échocardiographics factors, and brain imaging (scanner and MRI) will be analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients taken care in neurovascular unit | Experimental | Procedure: Holter 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cryptogenic TIA/Minor stroke
- Age > 18 years
- Medical care in Neuro Vascular Unit of CH Versailles
- Holter 21 days performed
Key exclusion criteria (6 listed)
- ACFA history
- ECG or telemetry who showed ACFA before the Holter initializing
- Carotid Stenosis / symptomatic vertebral
- Arterial dissection
- Prothrombotic state demonstrated by laboratory tests
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 |
|---|---|---|
| Holter 21 days | Procedure or surgery | Patients taken care in neurovascular unit |
Primary outcome
Number of atrial fibrillation detected on long duration ( 21 days) cardiac rythm holter monitoring
Time frame: Day 21
Atrial fibrillation >= 30 secondes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Results publication: PubMed 27495831Sudacevschi V, Bertrand C, Chadenat ML, Tarnaud C, Pico F. Predictors of Occult Atrial Fibrillation in One Hundred Seventy-One Patients with Cryptogenic Transient Ischemic Attack and Minor Stroke. J Stroke Cerebrovasc Dis. 2016 Nov;25(11):2673-2677. doi: 10.1016/j.jstrokecerebrovasdis.2016.07.014. Epub 2016 Aug 2.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holter 21 days in people with Cryptogenic Transient Ischemic Attack and Minor Stroke, run by Versailles Hospital at 1 site in France.
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: finished, as of the sponsor's last update on 25 May 2017. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of atrial fibrillation detected on long duration ( 21 days) cardiac rythm holter monitoring (time frame: Day 21). 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 NCT03166969, 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 25 May 2017.