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.
Condition or disease |
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Ischemic Stroke |
Study Type : | Observational |
Estimated Enrollment : | 720 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke |
Actual Study Start Date : | January 23, 2018 |
Estimated Primary Completion Date : | March 2023 |
Estimated Study Completion Date : | March 2023 |
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Informed consent from patient or family after the admission scan (unless the patient died).
Exclusion Criteria:
Contact: Frans Kauw, MD | +3188-7571680 | f.kauw-3@umcutrecht.nl |
Netherlands | |
Amsterdam UMC, location AMC | Not yet recruiting |
Amsterdam, Noord-Holland, Netherlands, 1105 AZ | |
Contact: Valeria Guglielmi, MD +3120-5664591 v.guglielmi@amsterdamumc.nl | |
Principal Investigator: Charles B.L.M. Majoie, MD PhD | |
Sub-Investigator: Valeria Guglielmi, MD | |
Sub-Investigator: Jonathan M. Coutinho, MD PhD | |
St. Antonius Hospital | Not yet recruiting |
Nieuwegein, Utrecht, Netherlands, 3435 CM | |
Contact: Wouter van Es, MD PhD +3188-3208064 h.es@antoniusziekenhuis.nl | |
Principal Investigator: Wouter van Es, MD PhD | |
University Medical Center Utrecht | Recruiting |
Utrecht, Netherlands, 3584 CX | |
Contact: Frans Kauw, MD +31 88 75 716 80 f.kauw-3@umcutrecht.nl | |
Principal Investigator: Jan W Dankbaar, MD PhD | |
Sub-Investigator: Frans Kauw, MD | |
Sub-Investigator: Richard A.P. Takx, MD PhD |
Tracking Information | |||||
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First Submitted Date | July 10, 2019 | ||||
First Posted Date | July 15, 2019 | ||||
Last Update Posted Date | July 19, 2019 | ||||
Actual Study Start Date | January 23, 2018 | ||||
Estimated Primary Completion Date | March 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Recurrent ischemic stroke [ Time Frame: 2 years ] | ||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke | ||||
Official Title | Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke | ||||
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. |
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
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. | ||||
Condition | Ischemic Stroke | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
720 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | March 2023 | ||||
Estimated Primary Completion Date | March 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Netherlands | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04019483 | ||||
Other Study ID Numbers | NL62233.041.17 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Jan. W. Dankbaar, MD, PhD, UMC Utrecht | ||||
Study Sponsor | UMC Utrecht | ||||
Collaborators |
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Investigators | Not Provided | ||||
PRS Account | UMC Utrecht | ||||
Verification Date | July 2019 |