Ischemic StrokeASSAMNCT02654795
Assessment of Left Atrial Appendage Morphology in Patients After Ischemic Stroke
A study testing computed tomography in people with Ischemic Stroke, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial summary
Stroke remains the most dangerous and frightening complication of atrial fibrillation (AF). Numerous factors predisposing to peripheral embolism in patients with AF have been well defined, documented and included in the CHA2DS2VASC score. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- computed tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2013to Jul 2016
- 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
- history of ischemic stroke or transient ischemic attack
- history of AF/AL
- known status of anticoagulation at the time of stroke (treatment dose, INR level)
Who cannot join
- hemorrhagic stroke
- serious renal impairment with GFR <30 ml/min
- hyperthyroidism
- allergy to the contrast agent
- mental inability to sign the informed consent
- receptive aphasia
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Grenadierow 51/59
Warsaw, 04 073
Piotr Kulakowski, MD, PhD, 0048602655728, pkulak@kkcmkp.pl
Jakub Baran, MD,PhD, 0048697604544, j.baran@sampi.pl
About this study
Official title: AssesSment of the Left Atrial Appendage morphoLogy in Patients aAfter ischeMic Stroke
Stroke remains the most dangerous and frightening complication of atrial fibrillation (AF). Numerous factors predisposing to peripheral embolism in patients with AF have been well defined, documented and included in the CHA2DS2VASC score. Although proper anticoagulation minimizes the risk attributable to "known" risk factors, stroke may still occur. Thus, "unknown" risk factors may play an important role in stroke risk stratification in patients with AF. The investigators assume that one of the important "unknown" risk factor is left atrial appendage (LAA) morphology. The ASSAM study is planned to include 100 patients after ischemic stroke or transient ischemic attack (TIA) and known status of anticoagulation at the time of stroke. The control group will consist of 100 patients scheduled for AF ablation without a history of stroke or TIA.
- Conditions
- Ischemic Stroke
- Being tested
- computed tomography
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomographyRadiation
CT angiography will be performed with a dual-source CT scanner using prospective ECG gating, with detector collimation of 128x0.6 mm, a gantry rotation time of 280 ms, tube voltage of 100-120 kV, tube current of 280-380 mAs depending on the patient's body mass.
| Study group | Role | What they receive |
|---|---|---|
| Patients without stroke | Placebo comparator | This group will consists of patients scheduled for atrial fibrillation ablation without history of stroke. Receives: Radiation: computed tomography |
| Patients with history of stroke | Experimental | This group will consists of patients after ischemic stroke and history of atrial fibrillation. Receives: Radiation: computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The LAA morphology in patients with an elevated risk of peripheral thromboembolism defined as CHA2DS2-VAScore >2
The investigators will examine association of specific type of LAA morphology with ischemic stroke taking in to account anticoagulation in the time of stroke/TIA.
The morphology of LAA will be divided into 4 types:
- the chicken wing - LAA with only one lobe, its length exceeds 40 mm and its bend angle is less than 100 degrees
- the windsock - LAA with one dominant lobe (length > 40 mm) and several secondary, or even tertiary ones, its length exceeds 40 mm and its bend angle exceeds 100 degrees
- the cauliflower - LAA with a variable number of lobes with lack of a dominant lobe, its total length is less than 40 mm
- the cactus - LAA with a dominant central lobe with several secondary ones, its total length less than 40 mm
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startAug 2013
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakub Baran MD PhD, Centre of Postgraduate Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654795
- Sponsor's protocol ID
- 501-1-10-14-13
- Acronym
- ASSAM
- Status last verified
- Jan 2016
- First submitted
- 7 Jan 2016
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AssesSment of the Left Atrial Appendage morphoLogy in Patients aAfter ischeMic Stroke
- ClinicalTrials.gov ID
- NCT02654795
- Acronym / sponsor ID
- ASSAM / 501-1-10-14-13
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 13 Jan 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 remains the most dangerous and frightening complication of atrial fibrillation (AF). Numerous factors predisposing to peripheral embolism in patients with AF have been well defined, documented and included in the CHA2DS2VASC score. Although proper anticoagulation minimizes the risk attributable to "known" risk factors, stroke may still occur. Thus, "unknown" risk factors may play an important role in stroke risk stratification in patients with AF. The investigators assume that one of the important "unknown" risk factor is left atrial appendage (LAA) morphology. The ASSAM study is planned to include 100 patients after ischemic stroke or transient ischemic attack (TIA) and known status of anticoagulation at the time of stroke. The control group will consist of 100 patients scheduled for AF ablation without a history of stroke or TIA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without stroke | Placebo comparator | Radiation: computed tomographyThis group will consists of patients scheduled for atrial fibrillation ablation without history of stroke. |
| Patients with history of stroke | Experimental | Radiation: computed tomographyThis group will consists of patients after ischemic stroke and history of atrial fibrillation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- history of ischemic stroke or transient ischemic attack
- history of AF/AL
- known status of anticoagulation at the time of stroke (treatment dose, INR level)
Key exclusion criteria (6 listed)
- hemorrhagic stroke
- serious renal impairment with GFR <30 ml/min
- hyperthyroidism
- allergy to the contrast agent
- mental inability to sign the informed consent
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 |
|---|---|---|
| computed tomographyCT angiography will be performed with a dual-source CT scanner using prospective ECG gating, with detector collimation of 128x0.6 mm, a gantry rotation time of 280 ms, tube voltage of 100-120 kV, tube current of 280-380 mAs depending on the patient's body mass. | Radiation | Patients with history of stroke, Patients without stroke |
Primary outcome
The LAA morphology in patients with an elevated risk of peripheral thromboembolism defined as CHA2DS2-VAScore >2
Time frame: Through study completion, an average of 1 year
The investigators will examine association of specific type of LAA morphology with ischemic stroke taking in to account anticoagulation in the time of stroke/TIA. The morphology of LAA will be divided into 4 types: * the chicken wing - LAA with only one lobe, its length exceeds 40 mm and its bend angle is less than 100 degrees * the windsock - LAA with one dominant lobe (length > 40 mm) and several secondary, or even tertiary ones, its length exceeds 40 mm and its bend angle exceeds 100 degrees * the cauliflower - LAA with a variable number of lobes with lack of a dominant lobe, its total length is less than 40 mm * the cactus - LAA with a dominant central lobe with several secondary ones, its total length less than 40 mm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Individual participant dataSharing planned: No
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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.
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Grenadierow 51/59
Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computed tomography in people with Ischemic Stroke, run by Centre of Postgraduate Medical Education at 1 site in Poland.
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 3 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 13 Jan 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 Poland. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The LAA morphology in patients with an elevated risk of peripheral thromboembolism defined as CHA2DS2-VAScore >2 (time frame: Through study completion, an average of 1 year). 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 13 Jan 2016.