Ischemic StrokeENCLOSENCT04019483
Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke
An observational study of Ischemic Stroke, run by UMC Utrecht at 3 sites in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 439 participants
- Where
- 3 sitesNetherlands
- Study dates
- 23 Jan 2018to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with another diagnosis such as intracerebral hemorrhage, subarachnoid hemorrhage or tumor;
- Patients with known contrast allergy or renal failure.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105 AZ
St. Antonius Hospital
Nieuwegein, Utrecht, 3435 CM
University Medical Center Utrecht
Utrecht, 3584 CX
About this study
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.
Read more
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.
- Conditions
- Ischemic Stroke
- Keywords
- Recurrence, Infarct detection, CT, MRI, Diagnosis, Prognosis
- Medical subject headings
- Ischemic Stroke, Recurrence, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent ischemic stroke
Measured: 2 years
Secondary outcomes (2)
Recurrent ischemic stroke
Measured: 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.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
9 - No data.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start23 Jan 2018
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Why it stopped: Insufficient inclusion and end of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation, Netherlands Organisation for Scientific Research
- Responsible party
- Principal investigator, Jan. W. Dankbaar, MD, PhD, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019483
- Sponsor's protocol ID
- NL62233.041.17
- Acronym
- ENCLOSE
- Status last verified
- May 2024
- First submitted
- 10 Jul 2019
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36779342Kauw 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.
PubMed 33598562
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke
- ClinicalTrials.gov ID
- NCT04019483
- Acronym / sponsor ID
- ENCLOSE / NL62233.041.17
- Conditions
- Ischemic Stroke
- Keywords
- Recurrence, Infarct detection, CT, MRI, Diagnosis, Prognosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient inclusion and end of funding
- Enrolment
- 439 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Dutch Heart Foundation, Netherlands Organisation for Scientific Research
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- Patients with another diagnosis such as intracerebral hemorrhage, subarachnoid hemorrhage or tumor;
- Patients with known contrast allergy or renal failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrent ischemic stroke
Time frame: 2 years
2 secondary outcomes
Recurrent ischemic stroke
Time frame: 90 days
modified Rankin scale
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Insufficient inclusion and end of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 36779342Kauw 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.
- Derived from this study: PubMed 33598562Kauw 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by UMC Utrecht at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient inclusion and end of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent ischemic stroke (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04019483, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.