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Insufficient inclusion and end of funding
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| Name | Class |
|---|---|
| Dutch Heart Foundation | OTHER |
| Netherlands Organisation for Scientific Research | OTHER_GOV |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Recurrent ischemic stroke | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent ischemic stroke | 90 days | |
| modified Rankin scale | The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. 0 - No symptoms.
9 - No data. |
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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).
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC, location AMC | Amsterdam | North Holland | 1105 AZ | Netherlands | ||
| St. Antonius Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36779342 | Derived | Kauw F, Velthuis BK, Takx RAP, Guglielmo M, Cramer MJ, van Ommen F, Bos A, Bennink E, Kappelle LJ, de Jong HWAM, Dankbaar JW. Detection of Cardioembolic Sources With Nongated Cardiac Computed Tomography Angiography in Acute Stroke: Results From the ENCLOSE Study. Stroke. 2023 Mar;54(3):821-830. doi: 10.1161/STROKEAHA.122.041018. Epub 2023 Feb 13. | |
| 33598562 |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D012008 | Recurrence |
| D004194 | Disease |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 90 days |
| Nieuwegein |
| Utrecht |
| 3435 CM |
| Netherlands |
| University Medical Center Utrecht | Utrecht | 3584 CX | Netherlands |
| 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. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |