Clinical trial NCT04019483: Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke
Official title: Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ischemic Stroke
Keywords: Recurrence
Infarct detection
CT
MRI
Diagnosis
Prognosis
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Dutch Heart Foundation
name: Netherlands Organisation for Scientific Research
First posted: 2019-07-15
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years or older with acute stroke symptoms who visited the UMC Utrecht, the Amsterdam UMC, location AMC or the St. Antonius Hospital and who underwent a CT-scan within 9 hours after onset of stroke symptoms.

Brief summary: Rationale: 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.

Objectives: 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 population: All patients who visited the University Medical Center (UMC) Utrecht, the Amsterdam University Medical Centers (Amsterdam UMC), location Academic Medical Center (AMC) or the St. Antonius Hospital and who underwent a CT-scan of the brain within 9 hours after onset of stroke symptoms with an age ≥18 years. Within 36 months, 720 patients will be enrolled in the study. Of these patients, 300 patients will be included for the follow-up magnetic resonance imaging (MRI).

Main study parameters/endpoints: The main study endpoints are: 1) Stroke recurrence rate at 2 years; 2) Presence and volume of acute ischemic lesions on follow-up diffusion weighted imaging MRI.


Eligibility criteria: Inclusion 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.

Exclusion Criteria:

* Patients with another diagnosis such as intracerebral hemorrhage, subarachnoid hemorrhage or tumor;
* Patients with known contrast allergy or renal failure.

Primary outcomes:
measure: Recurrent ischemic stroke
timeFrame: 2 years
Secondary outcomes:
measure: Recurrent ischemic stroke
timeFrame: 90 days
measure: modified Rankin scale
timeFrame: 90 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
state: Noord-Holland
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
state: Utrecht
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References:
citation: Kauw F, van Ommen F, Bennink E, Cramer MJ, Kappelle LJ, Takx RA, Velthuis BK, Viergever MA, Wouter van Es H, Schonewille WJ, Coutinho JM, Majoie CB, Marquering HA, de Jong HW, Dankbaar JW. Early detection of small volume stroke and thromboembolic sources with computed tomography: Rationale and design of the ENCLOSE study. Eur Stroke J. 2020 Dec;5(4):432-440. doi: 10.1177/2396987320966420. Epub 2020 Oct 23.