1) To identify clinical and imaging predictors of recurrent stroke; 2) To improve early detection of small volume stroke with admission computed tomography perfusion (CTP) in patients with suspected acute ischemic stroke with small volume stroke or…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Central nervous system vascular disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Stroke recurrence rate at 2 years;
• Presence and volume of acute ischemic lesions on follow-up diffusion weighted
imaging (DWI) MRI.
Secondary outcome
• Stroke recurrence rate at 2 days, 10 days and 90 days;
• Cardiac thrombus on trans-thoracic echography (TTE), trans-esophageal
echography (TEE) or ECG-gated cardiac CTA in patients with suspected thrombus
on admission CTA (as part of standard clinical practice, patients with
suspected cardiac thrombus on admission CTA and patients without an obvious
other cause of ischemic stroke will be referred to a cardiologist to confirm or
detect a cardioembolic source with trans-thoracic echography followed by
trans-esophageal echography if necessary or additional ECG-gated cardiac CTA);
• Atherosclerotic plaque composition of the extracranial internal carotid
artery or carotid bifurcation on contrast enhanced MRI;
• 90 day modified Rankin scale.
Background summary
Over 20.000 people suffer an ischemic stroke in the Netherlands each year.
Large artery occlusions are easy to identify and can be treated with
endovascular clot removal. 70% of patient will however suffer from a more
distal occlusion resulting in small volume stroke or a transient ischemic
attack (TIA). Small ischemic lesions are hard to detect with current acute
stroke protocols. TIA and small volume stroke patients, are at an increased
risk for recurrent stroke, making immediate diagnosis critical. Because
thrombo-embolic sources often cause these strokes, identifying and treating the
underlying aetiology has the potential to radically lower the risk of
recurrence and improve the outcome of these patients.
Study objective
1) To identify clinical and imaging predictors of recurrent stroke;
2) To improve early detection of small volume stroke with admission computed
tomography perfusion (CTP) in patients with suspected acute ischemic stroke
with small volume stroke or no ischemia on admission imaging.
Study design
Prospective, multicenter cohort study.
Study burden and risks
All imaging and clinical data of patients with written informed consent will be
collected during a period of 2 years, to determine the rate of stroke
recurrence and identify clinical and imaging predictors of stroke recurrence.
As part of standard care, patients will be contacted for follow-up evaluation
by a trained stroke nurse or neurologist (resident) at 90 days. For this study,
patients will be asked for a second follow-up evaluation by telephone at 2
years.
Patients with small volume stroke or no ischemia on admission imaging will be
asked for informed consent to undergo MRI of the brain within 48 hours after
admission. If an MRI of the brain is performed within the scope of standard
care within 48 hours after admission, the data of this clinical MRI scan will
be used and the patient does not need to undergo an additional MRI scan.
The risk of the MRI is minimized by careful screening. The risk of severe
allergic reaction due to administration of gadolinium is extremely low (0.006%).
The additional MRI will result in more certainty regarding the presence of
ischemic stroke. Patients who are not able to understand or express their
informed consent, will not be asked for the MRI part of this study.
Informed consent will be asked separately for 1) the use of the admission CT
data, patient information, and clinical follow-up; and 2) the acquisition of
the additional follow-up MRI (if applicable).
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Age >=18 years;
• Time from symptom onset until imaging is <9 hours*;
• Clinical diagnosis of acute ischemic stroke or TIA;
• Informed consent from patient or family after the admission scan (unless the patient died).
* Patients who awaken with stroke symptoms can only be included if they went to sleep without any stroke symptoms and the time from going to sleep until imaging is less than 9 hours.;To be eligible for a follow-up MRI, a subject must meet all of the following criteria:
• Occlusion distal to the A2 segment of the anterior cerebral artery, occlusion distal to the M1-M2 bifurcation of the middle cerebral artery, occlusion of the posterior cerebral artery (no occlusion of the basilar artery) or no visible occlusion as determined on the admission CTA scan;
• No contraindications for MRI.
Exclusion criteria
• Patients with another diagnosis such as intracerebral hemorrhage, subarachnoid hemorrhage or tumor;
• Patients with known contrast allergy or renal failure.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62233.041.17 |