Stroke, AcuteaICPStrokeNCT03641963
aICP Measurement in Patients With Cerebral Artery Infarction / aICP MCA Infarction
A study testing Vittamed 205 Non-invasive intracranial pressure (ICP) meter in people with Stroke, Acute, run by Kantonsspital Aarau at 1 site in Switzerland.
Trial summary
Space-occupying, malignant middle cerebral artery (M-MCA) infarctions are still one of the most devastating forms of ischemic stroke, with a mortality of up to 80% in untreated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Vittamed 205 Non-invasive intracranial pressure (ICP) meter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2018to 31 Dec 2021
- Phase
- Interventional
- 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
Who may be able to join
- Patient with an ischemic stroke in the internal carotid artery or middle cerebral artery territory at risk of a malignant MCA evolution, defined based on clinical presentation, clinical course (showing a progressive deterioration of conscious within the first 24-48 h), and neuroradiological findings.
- Age: ≥ 18 years at admission
- Informed consent of the patient or consent of patient's next of kin (plus consent of an independent physician)
Who cannot join
- Patients with wounds, scars including the front orbital region.
- Patients with any known ocular condition that may be worsened by sustained eye pressure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Absolute Intracranial Pressure Measurement in Patients With Malignant Middle Cerebral Artery Infarction for Determination of Timing to Decompressive Craniectomy
Space-occupying, malignant middle cerebral artery (M-MCA) infarctions are still one of the most devastating forms of ischemic stroke, with a mortality of up to 80% in untreated patients. It is reported that early hemicraniectomy leads to a substantial decrease in mortality at 6 and 12 months and is likely to improve functional outcome. Thus, this study investigates if non-invasive intracranial pressure (ICP) measuring could represent an objective value to determine the time point to indicate decompressive craniectomy surgery.
However, there are still important questions about the individual indication for decompressive surgery. In consideration of a variable clinical course (some patients develop fatal brain edema early, whereas other patients do not show severe brain swelling for several days), achieving a way to measure, control and predict malignant brain edema formation would be of extremely important value.
Read the detailed description
Space-occupying, malignant middle cerebral artery (M-MCA) infarctions are still one of the most devastating forms of ischemic stroke, with a mortality of up to 80% in untreated patients.
Actually, M-MCA infarctions constitute between 1% to 10% of all supratentorial ischemic strokes, with a yearly incidence about 10-20/100.000 people. The etiology of malignant MCA infarctions is mostly due to thrombosis or embolic occlusion of either the internal carotid artery or the proximal MCA. The term M-MCA is referred to a severe MCA syndrome with typical clinical symptoms (hemiparesis to hemiplegia, severe sensory deficits, head and eye deviation, hemi-inattention, and, if the dominant hemisphere is involved, global aphasia), following a uniform clinical course (progressive deterioration of conscious within the first 24-48 h), and ending in herniation. An early diagnosis is essential and depends on CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) to aid the prediction of a malignant course, but, until today there is no clear consensus to define and predict radiologically a malignant evolution in early phases.
Several pharmacological strategies have been proposed but the efficacy of these approaches has not been supported by adequate evidence from clinical trials and, until recently, treatment of malignant MCA infarctions has been a major unmet need.
Over the past 10 years, results from randomised controlled trials (RCT) (HAMLET, DECIMAL and DESTINY) and their pooled analyses have provided evidence that an early hemicraniectomy leads to a substantial decrease in mortality at 6 and 12 months and is likely to improve functional outcome. However, there are still important questions about the individual indication for decompressive surgery. In consideration of a variable clinical course (some patients develop fatal brain edema early, whereas other patients do not show severe brain swelling for several days), achieving a way to measure, control and predict malignant brain edema formation would be of extremely important value.
In this way, the ICP measuring could represent an objective value to determine in every patient the time point to indicate decompressive craniectomy surgery, and also could allow us to find a correlation between the size of the infarction and periinfarction edema. Therefore the optimal timing of surgical intervention can be defined and all the medical treatment adjusted.
Currently, ICP can be measured and registered only using invasive techniques. The two ICP measurement methods available - intraventricular and intraparenchymal - require both a neurosurgical procedure, in order to implant the catheter and probes within the brain. Thus, these measures include themselves a risk for the subject, and both infections and intracranial bleedings are regular albeit not frequent complications. In addition, invasive recording of ICP requires neurosurgical expertise and intensive care unit (ICU) facilities. Therefore ICP measurement so far, is not a standard of care in stroke units.
A reliable, accurate and precise non-invasive method to measure ICP would be of considerable clinical value, enabling ICP measurement without neurosurgical expertise and ICU facilities. Moreover, it would save the patients from the complication risks associated with invasive measures.
- Conditions
- Stroke, Acute
- Being tested
- Vittamed 205 Non-invasive intracranial pressure (ICP) meter
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vittamed 205 Non-invasive intracranial pressure (ICP) meterDevice
Non-Invasive intracranial pressure measurement
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients with ICP measurement | Experimental | All patients with the possibility to evolve a malignant MCA infarct according to the initial assessment, will be included in our study, to measure ICP non-invasive. The ICP will be measured non-invasive with the Vittamed 205 Non-invasive intracranial pressure (ICP) meter. Receives: Device: Vittamed 205 Non-invasive intracranial pressure (ICP) meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased intracranial pressure
The primary outcome is the non-invasive, absolute intra-cranial pressure (ICP) in M-MCA patients before decompressive surgery, as determined by the "non-invasive ICP absolute value meter" in mmHg
Measured: 24 months
Secondary outcomes (1)
Correlation of ICP, neuroimaging and transcranial color Doppler
Correlation between non-invasive measured ICP and clinical and neuroimaging findings and standard transcranial color Doppler
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Dec 2018
- Primary completion30 Sep 2019
- Study completion31 Dec 2021 (estimated)
Why it stopped: Safety questions on patients with glaucoma are in discussion by our IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Fandino, MD, Kantonsspital Aarau
- Investigators
- Javier Fandino, Principal investigator, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641963
- Sponsor's protocol ID
- aICP Stroke
- Acronym
- aICPStroke
- Status last verified
- Feb 2020
- First submitted
- 7 Aug 2018
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Absolute Intracranial Pressure Measurement in Patients With Malignant Middle Cerebral Artery Infarction for Determination of Timing to Decompressive Craniectomy
- ClinicalTrials.gov ID
- NCT03641963
- Acronym / sponsor ID
- aICPStroke / aICP Stroke
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Safety questions on patients with glaucoma are in discussion by our IRB
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Aug 2018 (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.
Space-occupying, malignant middle cerebral artery (M-MCA) infarctions are still one of the most devastating forms of ischemic stroke, with a mortality of up to 80% in untreated patients. It is reported that early hemicraniectomy leads to a substantial decrease in mortality at 6 and 12 months and is likely to improve functional outcome. Thus, this study investigates if non-invasive intracranial pressure (ICP) measuring could represent an objective value to determine the time point to indicate decompressive craniectomy surgery.
However, there are still important questions about the individual indication for decompressive surgery. In consideration of a variable clinical course (some patients develop fatal brain edema early, whereas other patients do not show severe brain swelling for several days), achieving a way to measure, control and predict malignant brain edema formation would be of extremely important value.
Detailed description
Space-occupying, malignant middle cerebral artery (M-MCA) infarctions are still one of the most devastating forms of ischemic stroke, with a mortality of up to 80% in untreated patients.
Actually, M-MCA infarctions constitute between 1% to 10% of all supratentorial ischemic strokes, with a yearly incidence about 10-20/100.000 people. The etiology of malignant MCA infarctions is mostly due to thrombosis or embolic occlusion of either the internal carotid artery or the proximal MCA. The term M-MCA is referred to a severe MCA syndrome with typical clinical symptoms (hemiparesis to hemiplegia, severe sensory deficits, head and eye deviation, hemi-inattention, and, if the dominant hemisphere is involved, global aphasia), following a uniform clinical course (progressive deterioration of conscious within the first 24-48 h), and ending in herniation. An early diagnosis is essential and depends on CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) to aid the prediction of a malignant course, but, until today there is no clear consensus to define and predict radiologically a malignant evolution in early phases.
Several pharmacological strategies have been proposed but the efficacy of these approaches has not been supported by adequate evidence from clinical trials and, until recently, treatment of malignant MCA infarctions has been a major unmet need.
Over the past 10 years, results from randomised controlled trials (RCT) (HAMLET, DECIMAL and DESTINY) and their pooled analyses have provided evidence that an early hemicraniectomy leads to a substantial decrease in mortality at 6 and 12 months and is likely to improve functional outcome. However, there are still important questions about the individual indication for decompressive surgery. In consideration of a variable clinical course (some patients develop fatal brain edema early, whereas other patients do not show severe brain swelling for several days), achieving a way to measure, control and predict malignant brain edema formation would be of extremely important value.
In this way, the ICP measuring could represent an objective value to determine in every patient the time point to indicate decompressive craniectomy surgery, and also could allow us to find a correlation between the size of the infarction and periinfarction edema. Therefore the optimal timing of surgical intervention can be defined and all the medical treatment adjusted.
Currently, ICP can be measured and registered only using invasive techniques. The two ICP measurement methods available - intraventricular and intraparenchymal - require both a neurosurgical procedure, in order to implant the catheter and probes within the brain. Thus, these measures include themselves a risk for the subject, and both infections and intracranial bleedings are regular albeit not frequent complications. In addition, invasive recording of ICP requires neurosurgical expertise and intensive care unit (ICU) facilities. Therefore ICP measurement so far, is not a standard of care in stroke units.
A reliable, accurate and precise non-invasive method to measure ICP would be of considerable clinical value, enabling ICP measurement without neurosurgical expertise and ICU facilities. Moreover, it would save the patients from the complication risks associated with invasive measures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients with ICP measurement | Experimental | Device: Vittamed 205 Non-invasive intracranial pressure (ICP) meterAll patients with the possibility to evolve a malignant MCA infarct according to the initial assessment, will be included in our study, to measure ICP non-invasive. The ICP will be measured non-invasive with the Vittamed 205 Non-invasive intracranial pressure (ICP) meter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with an ischemic stroke in the internal carotid artery or middle cerebral artery territory at risk of a malignant MCA evolution, defined based on clinical presentation, clinical course (showing a progressive deterioration of conscious within the first 24-48 h), and neuroradiological findings.
- Age: ≥ 18 years at admission
- Informed consent of the patient or consent of patient's next of kin (plus consent of an independent physician)
Key exclusion criteria (2 listed)
- Patients with wounds, scars including the front orbital region.
- Patients with any known ocular condition that may be worsened by sustained eye pressure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vittamed 205 Non-invasive intracranial pressure (ICP) meterNon-Invasive intracranial pressure measurement | Device | Stroke patients with ICP measurement |
Primary outcome
Increased intracranial pressure
Time frame: 24 months
The primary outcome is the non-invasive, absolute intra-cranial pressure (ICP) in M-MCA patients before decompressive surgery, as determined by the "non-invasive ICP absolute value meter" in mmHg
1 secondary outcome
Correlation of ICP, neuroimaging and transcranial color Doppler
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
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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.
Javier Fandino principal investigator
Kantonsspital Aarau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vittamed 205 Non-invasive intracranial pressure (ICP) meter in people with Stroke, Acute, run by Kantonsspital Aarau at 1 site in Switzerland.
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 3 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: paused, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
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?
Increased intracranial pressure (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2020.