StrokeNCT02968329
Left Atrial Function in Recurrent Stroke of Unknown Cause
An observational study of Stroke, run by Hasselt University at 1 site in Belgium.
Trial summary
Stroke is an important cause of disability and the third leading cause of death. Approximately 30 to 40 % of all strokes are estimated to be cryptogenic (i.e. no cause can be found). There have been few previous studies regarding risk stratification for stroke recurrence in patients with cryptogenic stroke. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2016to Apr 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Cryptogenic Stroke
Who may be able to join
- CVA
- TIA
Who cannot join
- proven AF or atrial flutter
- prior ablation for AF
- valvular disease
- artificial heart valves
- endocarditis
- presence of an atrial septum defect or moderate to large patent foramen ovale
Show all 25Show fewer
- LV akinesia
- moderate to severe carotid stenosis
- prior surgery for carotid artery stenosis
- total occlusion of the internal carotid artery
- carotid artery dissection
- vertebral artery dissection
- massive aortic atheromatosis
- temporal arteritis
- basilar artery aneurysm
- ascending aortic aneurysm
- subclavian steal
- prior CVA/TIA
- intracerebral hemorrhage
- lacunar infarction
- clotting disorder
- on anticoagulants
- CVA/TIA as a procedural complication
- hyperthyroidism
- patients who died in hospital after first admission for CVA/TIA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Left Atrial Function as Predictor of Recurrent Stroke or Paroxysmal Atrial Fibrillation in Patients With Cryptogenic Stroke
Stroke is an important cause of disability and the third leading cause of death.
Approximately 30 to 40 % of all strokes are estimated to be cryptogenic (i.e. no cause can be found). There have been few previous studies regarding risk stratification for stroke recurrence in patients with cryptogenic stroke.
Recent studies have suggested that left atrial (LA) function is an important determinant of stroke risk. However, most studies focus on volume indices and LA dimensions, we also want to investigate other echocardiographic parameters. The aim of this study is to assess the predictive value of left atrial function for the risk of stroke recurrence and/or atrial fibrillation by transthoracic echocardiography in cryptogenic stroke patients with no proven atrial fibrillation (AF) and no indication for anticoagulants.
Read the detailed description
Study design and population The investigators used a retrospective mono-centric case-control design and analyzed all patients admitted for cerebrovascular accident (CVA) or transient ischemic attack (TIA) between 2011 and 2014. The investigators searched for patients who had a recurrent CVA/TIA and/or who were diagnosed with newly documented AF during the study duration. Clinical, demographic and laboratory parameters were assessed. Echocardiographic parameters, measured on first admission, were analyzed using EchoPAC version 112.
Statistical analysis Univariate analysis was performed for all covariates using the Cox proportional hazards model. Likelihood ratio tests were used to determine significance for all parameters.
If covariates were significant at the 25% significance level, they were used in the multivariate model.
Multivariate analysis was performed using the Cox proportional hazards model with backward elimination model selection. The Wald Chi-Square test was used to determine significance at 5% significance level. The program used for analysis is SAS version 9.4.
- Conditions
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CVA cases | patients who experienced an ischemic CVA or TIA during the study duration and experienced a recurrence. | |
| CVA controls | patients who experienced an ischemic CVA or TIA during the study duration, but who didn't experience a recurrence. | |
| AF cases | patients who experienced an ischemic CVA or TIA during the study duration and who got diagnosed with 'new' AF | |
| AF controls | patients who experienced an ischemic CVA or TIA during the study duration but who didn't get diagnosed with 'new' AF during the study duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent ischemic CVA or TIA
Recurrent ischemic CVA or TIA from first ischemic CVA or TIA after 31-12-2010 until date of first documented recurrence, assessed up to four years
Measured: up to four years
Secondary outcomes (1)
'New' diagnosis of AF
'New' diagnosis of AF from first ischemic CVA or TIA after 31-12-2010 until date of documented 'new' AF, assessed up to four years
Measured: Up to four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, prof. dr. Paul Dendale, Hasselt University
- Investigators
- Paul Dendale, prof. dr., Principal investigator, Jessa HospitalBram Verdonck, student, Study chair, Hasselt UniversityJens Jeurissen, student, Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968329
- Sponsor's protocol ID
- JJBV544
- Status last verified
- Aug 2017
- First submitted
- 13 Nov 2016
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Function as Predictor of Recurrent Stroke or Paroxysmal Atrial Fibrillation in Patients With Cryptogenic Stroke
- ClinicalTrials.gov ID
- NCT02968329
- Acronym / sponsor ID
- JJBV544
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- Oct 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 18 Nov 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.
Stroke is an important cause of disability and the third leading cause of death.
Approximately 30 to 40 % of all strokes are estimated to be cryptogenic (i.e. no cause can be found). There have been few previous studies regarding risk stratification for stroke recurrence in patients with cryptogenic stroke.
Recent studies have suggested that left atrial (LA) function is an important determinant of stroke risk. However, most studies focus on volume indices and LA dimensions, we also want to investigate other echocardiographic parameters. The aim of this study is to assess the predictive value of left atrial function for the risk of stroke recurrence and/or atrial fibrillation by transthoracic echocardiography in cryptogenic stroke patients with no proven atrial fibrillation (AF) and no indication for anticoagulants.
Detailed description
Study design and population The investigators used a retrospective mono-centric case-control design and analyzed all patients admitted for cerebrovascular accident (CVA) or transient ischemic attack (TIA) between 2011 and 2014. The investigators searched for patients who had a recurrent CVA/TIA and/or who were diagnosed with newly documented AF during the study duration. Clinical, demographic and laboratory parameters were assessed. Echocardiographic parameters, measured on first admission, were analyzed using EchoPAC version 112.
Statistical analysis Univariate analysis was performed for all covariates using the Cox proportional hazards model. Likelihood ratio tests were used to determine significance for all parameters.
If covariates were significant at the 25% significance level, they were used in the multivariate model.
Multivariate analysis was performed using the Cox proportional hazards model with backward elimination model selection. The Wald Chi-Square test was used to determine significance at 5% significance level. The program used for analysis is SAS version 9.4.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CVA cases | – | –patients who experienced an ischemic CVA or TIA during the study duration and experienced a recurrence. |
| CVA controls | – | –patients who experienced an ischemic CVA or TIA during the study duration, but who didn't experience a recurrence. |
| AF cases | – | –patients who experienced an ischemic CVA or TIA during the study duration and who got diagnosed with 'new' AF |
| AF controls | – | –patients who experienced an ischemic CVA or TIA during the study duration but who didn't get diagnosed with 'new' AF during the study duration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Cryptogenic Stroke
Key inclusion criteria (2 listed)
- CVA
- TIA
Key exclusion criteria (25 listed)
- proven AF or atrial flutter
- prior ablation for AF
- valvular disease
- artificial heart valves
- endocarditis
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
Recurrent ischemic CVA or TIA
Time frame: up to four years
Recurrent ischemic CVA or TIA from first ischemic CVA or TIA after 31-12-2010 until date of first documented recurrence, assessed up to four years
1 secondary outcome
'New' diagnosis of AF
Time frame: Up to four years
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 10 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Paul Dendale, prof. dr. principal investigator
Jessa Hospital
Bram Verdonck, student study chair
Hasselt University
Jens Jeurissen, student study chair
Hasselt University
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 Hasselt University at 1 site in Belgium.
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 25 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 10 Aug 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 Belgium. 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?
Recurrent ischemic CVA or TIA (time frame: up to four years). 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 10 Aug 2017.