NCT03329365Active, not recruiting
Paroxysmal Nocturnal Hemoglobinuria in ESUS & ETUS
Paroxysmal Nocturnal Hemoglobinuria and Embolic Strokes of Undetermined Source (ESUS) and Transient Ischemic Attacks of Undetermined Source (ETUS)
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
Paroxysmal nocturnal hemoglobinuria (PNH) is a rare acquired clonal hematological disorder, which can cause arterial or venous thrombosis. The frequency of PNH in young patients (\< 50 years old) with embolic stroke (ESUS), transient ischemic attack (ETUS) or superior sagittal sinus cerebral venous thrombosis (SSS-CVTUS) of undetermined source, is currently unknown. This study proposes to recruit ESUS, ETUS, SSS-CVTUS patients to determine the frequency of PNH diagnosis confirmed by flow cytometry in these patient populations.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 30 Oct 2017
- Start date
- 1 Nov 2018
- Primary completion date
- 29 Mar 2023
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Diseases
- Stroke
- NCT number
- NCT03329365
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 Nov 2018 to the primary completion date, 29 Mar 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Inability to provide informed consent
- For stroke patients:
- Evidence of \>50% stenosis of the internal carotid artery (ICA) or MCA ipsilateral to the qualifying ischemic stroke on neurovascular imaging studies.
- Ischemic stroke involving deep structures and measuring \< 15 mm on diffusion-weighted (DWI) magnetic resonance imaging (MRI). Cortical strokes measuring \<15 mm will qualify to be included in the study.
- Evidence of a cause explaining the stroke (e.g. hypercoagulable state or any other major source of cardiac embolism).
- For TIA patients:
- Patients no fulfilling the criteria for ETUS.
- For cerebral venous thrombosis patients:
- Subjects with an evident cause explaining the thrombosis (e.g., thrombophilia)
Other
- General:
- Subjects without involvement of the superior sagittal sinus (SSS)
Who the study is looking for
- General:
- Participants with embolic ischemic stroke (ESUS), embolic transient ischemic attack (ETUS) or cerebral venous thrombosis (CVTUS) of undetermined source.
- For transient ischemic attack (TIA):
- One of the following criteria needs to be fulfilled to be considered as embolic TIA:
- Focal symptoms suggesting involvement of de cerebral cortex in the middle cerebral artery (MCA) territory (e.g., aphasia, neglect, apraxia, dystextia, anosognosia, isolated leg, arm or hand weakness). Some of these symptoms have been described as associated with subcortical fibers connecting cortical areas as well but, despite this, they are usually related to cortical localizations. Patients with hemianopia will be included only if hemianopia is not the primary symptom or an isolated symptom.
- Rapidly resolving hemispheric symptoms. This concept comprises two components: (a) sudden onset hemispheric syndrome: sudden onset of symptoms and signs implicating extensive ischemia in the internal carotid artery (ICA) or MCA territories, including hemiparesis, hemianopia, conjugate eye deviation, other cortical signs, or altered consciousness; and (b) spectacular shrinking deficit: improvement within 24 hours (approximately).
- Symptoms involving more than one vascular territory within a single hemisphere (e.g. left sided weakness + left homonymous hemianopia) or both (e.g., left sided weakness and aphasia in a right-handed patient).
- Simultaneous embolization to other organs (e.g., bowel, spleen, liver, kidneys, toes).
- Transient monocular blindness (amaurosis fugax) with no evidence of giant cell arteritis (e.g., normal erythrocyte sedimentation rate).
- No definite cortical symptoms but neuroimaging evidence of prior (chronic) typical infarct (wedge shaped, involving the cerebral cortex).
- All of the following criteria must be fulfilled to be considered as TIA of undetermined source:
- No neuroimaging evidence of an acute brain infarct within the brain region(s) responsible for the presenting symptoms.
- Absence of extracranial or intracranial atherosclerosis causing ≥50% luminal stenosis in arteries supplying the area of ischemia.
- No major-risk cardioembolic source of embolism.
- No other specific cause of stroke identified (e.g., arteritis, dissection, migraine, vasospasm, or drug abuse).
- No persistent neurological focal symptoms at the time of neurological examination. The presence of persistent neurological focal symptoms in the absence of a visible brain infarct on DWI MRI will be regarded as a "clinically confirmed stroke with negative DWI MRI".
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.