Acute Ischemic StrokeNCT02415972
Dynamic Contrast-enhanced Ultrasound Imaging for Cerebral Perfusion Measurement in Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Stroke, a personal, familial, and social disaster, is the first cause of acquired disability, the second cause of dementia, and the third cause of death worldwide. Its associated socio-economic costs are astronomic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Ultrasound perfusion imaging
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2012to Apr 2016
- 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: The trial population comprises of patients with acute ischemic stroke treated at the University Hospital Bern.
Who may be able to join
- All patients with an indication for iv thrombolysis or endovascular treatment according to the current stroke guidelines of the University Hospital Bern
- Age ≥18
- Written informed consent by patient or next of kin
- Signed consent of independent physician
Who cannot join
- Positive pregnancy test and breast feeding
- Acute coronary syndromes, severe ischemic heart disease (requiring revascularization), severe aortic and mitral valve disease, severe congestive heart failure (NYHA >III/IV)
- Severe pulmonary or renal dysfunction
- Known allergy or adverse reaction to contrast material
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neurosurgery, Bern University Hospital Bern
Bern, 3010
About this study
Stroke, a personal, familial, and social disaster, is the first cause of acquired disability, the second cause of dementia, and the third cause of death worldwide. Its associated socio-economic costs are astronomic. The burden of stroke is likely to increase, given the aging of the population and the growing incidence of many vascular risk factors. Therefore, apart from further development of stroke prevention and treatment strategies, rational and effective tools for diagnosis, monitoring, and follow-up for stroke patients have potential high long-term clinical and economic consequences.
For neuroradiological work-up, computed tomography (CT) or magnetic resonance imaging (MRI) are used as gold standard techniques to detect presence or absence, effective state, and extent of stroke. However, these techniques achieve simply a baseline study of ischemia occurred and can deliver only a snapshot of brain parenchyma and vessels. Furthermore, their rapid and actual availability, especially in primary hospitals, and their dynamic capabilities and predictive values for further infarction are poor with critically ill patients have to be repeatedly transferred to the scanning unit for each measurement. Whereas CT examination is associated with x-ray radiation and may miss early detection of stroke, MRI is associated with higher costs and not generally routinely and around-the clock available in all the hospitals. Therefore, a simple, fast, repeatable, non-hazardous, and non-invasive dynamic bedside tool for the detection of acute brain tissue hypoperfusion and monitoring for potential further infarction or efficacy of thrombolysis either by systemic intravenous thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) or by selective intraarterial fibrinolysis and mechanical recanalization, both combined with or without bridging after acute ischemic stroke, is strongly needed.
Read more
A promising alternative method of diagnosing stroke represents contrast-enhanced ultrasound perfusion imaging (UPI). What makes UPI so valuable is the advantage of repeatedly and non-invasively detecting brain tissue at risk for infarction by dynamic direct brain tissue perfusion assessment and not by surrogate parameters, like blood flow velocity or vessel diameter. Because of the possibility to screen and repeatedly measure the state of perfusion, the chances increase to diagnose and monitor ischemic stroke and to define the appropriate window for treatment. The perfusion analysis would also allow determination of treatment results and guidance of rapid and adequate further therapy.
Therefore, the present pilot study in 40 patients is initiated. The objectives of this observational diagnostic cohort trial are to evaluate feasibility and practicability of repeated bedside assessments by contrast enhanced UPI in acute ischemic stroke patients and to assess whether UPI can detect alterations in brain tissue perfusion before and after recanalising therapy of strokes. Assessment of cerebral perfusion by CT or MRI serves as reference and its results are compared to UPI data.
Read the detailed description
Background
Stroke is a personal, familial and social disaster. Apart from development of stroke prevention and treatment strategies, the mainstay of stroke research remains new-product development and improvement of current imaging tools for diagnosis, monitoring and follow-up of stroke patients. For initial neuroradiological work-up, usually computed tomography (CT) or magnetic resonance imaging (MRI) are used to detect presence or absence, effective state and extent of stroke. However, their rapid and actual availability, especially in primary hospitals, and their dynamic capabilities and predictive values for further infarction are poor. Currently cerebral CT-perfusion (CTP) imaging can be regarded as the gold standard for assessing tissue hypoperfusion in this setting. It employs, however, both contrast agent and X-ray exposition and patients have to be repeatedly transferred to the scanning unit for each measurement. Therefore, a fast, simple, repeatable, non-hazardous and non-invasive dynamic bedside tool for the detection of acute brain tissue hypoperfusion and monitoring for potential further infarction or efficacy of thrombolysis after ischemic stroke is strongly needed.
Socioeconomic importance of stroke Stroke is the first cause of acquired disability, the second cause of dementia and the third cause of death worldwide, and its associated socio-economic costs are astronomic. The burden of stroke is likely to increase, given the aging of the population and the growing incidence of many vascular risk factors. Therefore, rational and effective diagnostic and therapeutic management in stroke patients has potential high long-term clinical and economic consequences.
Current standard therapy after acute ischemic stroke According to the cause of stroke and apart from medical treatment and surgical options in selected cases, the mainstay of therapeutic management of acute ischemic stroke itself usually remain systemic intravenous thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) or selective intraarterial fibrinolysis and mechanical recanalization, both with or without bridging (combined intravenous and intraarterial thrombolysis). In this regard, reperfusion therapy is the only proven treatment for acute ischemic stroke.
Current problems in diagnosis and monitoring of stroke patients At present, CT and MRI are usually applied for diagnosis and follow-up of stroke. However, both CT and MRI achieve simply a baseline study of ischemia occurred and can deliver only a snapshot of brain parenchyma and vessels. Furthermore, whereas CT examination is associated with x-ray radiation and may miss early detection of stroke, MRI is associated with higher costs and is not generally routinely and around-the clock available in all the hospitals. Both imaging methods require transportation and intensive care of the often critically ill patients to the scanning unit for each measurement.
There is unanimous agreement about the need for a bedside assessment of the status of tissue perfusion. Invasive cerebral angiography is indicated in cases of further evaluation of stroke causes and intended endovascular therapy.
Potential of ultrasound perfusion imaging (UPI) What makes contrast enhanced UPI so valuable is the possibility to repeatedly and non-invasively detect brain tissue at risk for infarction by direct brain tissue perfusion assessment and not by surrogate parameters, like blood flow velocity or vessel diameter. Because of the possibility to screen and repeatedly measure the state of perfusion, the chances increase to diagnose and monitor ischemic stroke and to define the appropriate window for treatment. The perfusion analysis would also allow determination of treatment results and guidance of rapid and adequate further therapy.
Objective
The objective of the present study is to assess whether cerebral hypoperfusion can be detected by ultrasound perfusion imaging (UPI) before and after treatment of acute ischemic stroke.
Methods
Patients with acute middle cerebral artery (MCA) territory ischemic stroke are evaluated for potential thrombolysis/thrombectomy according to the Bernese neurologic stroke algorithm. An experienced neurosonographer performs contrast-enhanced ultrasound perfusion imaging (UPI) after prospective study enrollment and specific stroke CT/MRI with perfusion measurement. Clinical status is documented by use of the NIHSS on admission /first day after the intervention. UPI and CT/MRI perfusion data is analyzed. Two different quantification algorithms, standard versus patient-adjusted, are used. Data is analyzed by descriptive statistics using the mean, median and standard deviation of the ROIs. Sensitivity and specificity analyses are calculated using Pearson's chi-square test. Receiver-operator characteristic curves are calculated for UPI/perfusion MRI/CT parameters. Pearson correlation is used to evaluate correlations between absolute values of UPI and MRI TTP data.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Ultrasound perfusion imaging
- Keywords
- ultrasound imaging, acute ischemic stroke, cerebral perfusion measurement in acute ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound perfusion imagingOther
Dynamic perfusion imaging of brain parenchyma with modern ultrasound is possible with the use of ultrasound contrast media that serve as echo signal amplifier.
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Patients with Stroke Receives: Other: Ultrasound perfusion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with detection of cerebral hypoperfusion before and after thrombolytic treatment and correlation to established diagnostic gold standard CT- or MRI-perfusion studies by measurement of time to peak values
Measured: 1 day after intervention
Secondary outcomes (2)
Number of Patients with Adverse Events as a Measure of Safety and Tolerability and detection of early clinical outcome by NIHSS
Measured: 1 day after intervention
Quantitative analysis of metric parameters of UPI
Measured: 1 day after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startOct 2012
- Primary completionMar 2014
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jürgen Beck, Prof. Dr. med., Principal investigator, Department of Neurosurgery, Bern University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415972
- Sponsor's protocol ID
- 179/12
- Status last verified
- Jul 2016
- First submitted
- 27 Mar 2015
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Beck J, Raabe A, Lanfermann H, Seifert V, Weidauer S. Tissue at risk concept for endovascular treatment of severe vasospasm after aneurysmal subarachnoid haemorrhage. J Neurol Neurosurg Psychiatry. 2004 Dec;75(12):1779-81. doi: 10.1136/jnnp.2004.036921.
PubMed 15548506Beck J, Raabe A, Lanfermann H, Berkefeld J, De Rochemont Rdu M, Zanella F, Seifert V, Weidauer S. Effects of balloon angioplasty on perfusion- and diffusion-weighted magnetic resonance imaging results and outcome in patients with cerebral vasospasm. J Neurosurg. 2006 Aug;105(2):220-7. doi: 10.3171/jns.2006.105.2.220.
PubMed 17219826Beck J, Raabe A, Lanfermann H, Seifert V, Weidauer S. Perfusion-weighted magnetic resonance imaging in patients with vasospasm: a useful new tool in the management of patients with subarachnoid hemorrhage. Neurosurgery. 2006 Mar;58(3):E590; author reply E590. doi: 10.1227/01.NEU.0000207963.98939.7B. No abstract available.
PubMed 16528172Eyding J, Krogias C, Schollhammer M, Eyding D, Wilkening W, Meves S, Schroder A, Przuntek H, Postert T. Contrast-enhanced ultrasonic parametric perfusion imaging detects dysfunctional tissue at risk in acute MCA stroke. J Cereb Blood Flow Metab. 2006 Apr;26(4):576-82. doi: 10.1038/sj.jcbfm.9600216.
PubMed 16121127Seidel G, Meyer-Wiethe K, Berdien G, Hollstein D, Toth D, Aach T. Ultrasound perfusion imaging in acute middle cerebral artery infarction predicts outcome. Stroke. 2004 May;35(5):1107-11. doi: 10.1161/01.STR.0000124125.19773.40. Epub 2004 Mar 18.
PubMed 15031454Wiesmann M, Meyer K, Albers T, Seidel G. Parametric perfusion imaging with contrast-enhanced ultrasound in acute ischemic stroke. Stroke. 2004 Feb;35(2):508-13. doi: 10.1161/01.STR.0000114877.58809.3D. Epub 2004 Jan 22.
PubMed 14739406Kern R, Diels A, Pettenpohl J, Kablau M, Brade J, Hennerici MG, Meairs S. Real-time ultrasound brain perfusion imaging with analysis of microbubble replenishment in acute MCA stroke. J Cereb Blood Flow Metab. 2011 Aug;31(8):1716-24. doi: 10.1038/jcbfm.2011.14. Epub 2011 Mar 2.
PubMed 21364598Eyding J, Krogias C, Meves S, Przuntek H, Postert T. Quantitative ultrasonographic evaluation of cerebral perfusion in acute stroke is possible. Stroke. 2004 Nov;35(11):2432-3; author reply 2433. doi: 10.1161/01.STR.0000143731.48504.7d. Epub 2004 Sep 16. No abstract available.
PubMed 15375306Engelhardt M, Hansen C, Eyding J, Wilkening W, Brenke C, Krogias C, Scholz M, Harders A, Ermert H, Schmieder K. Feasibility of contrast-enhanced sonography during resection of cerebral tumours: initial results of a prospective study. Ultrasound Med Biol. 2007 Apr;33(4):571-5. doi: 10.1016/j.ultrasmedbio.2006.10.007.
PubMed 17337111Kopp R, Zurn W, Weidenhagen R, Meimarakis G, Clevert DA. First experience using intraoperative contrast-enhanced ultrasound during endovascular aneurysm repair for infrarenal aortic aneurysms. J Vasc Surg. 2010 May;51(5):1103-10. doi: 10.1016/j.jvs.2009.12.050.
PubMed 20420978
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Contrast-enhanced Ultrasound Imaging for Cerebral Perfusion Measurement in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02415972
- Acronym / sponsor ID
- 179/12
- Conditions
- Acute Ischemic Stroke
- Keywords
- ultrasound imaging, acute ischemic stroke, cerebral perfusion measurement in acute ischemic stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 Apr 2015 (estimated)
- 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.
Stroke, a personal, familial, and social disaster, is the first cause of acquired disability, the second cause of dementia, and the third cause of death worldwide. Its associated socio-economic costs are astronomic. The burden of stroke is likely to increase, given the aging of the population and the growing incidence of many vascular risk factors. Therefore, apart from further development of stroke prevention and treatment strategies, rational and effective tools for diagnosis, monitoring, and follow-up for stroke patients have potential high long-term clinical and economic consequences.
For neuroradiological work-up, computed tomography (CT) or magnetic resonance imaging (MRI) are used as gold standard techniques to detect presence or absence, effective state, and extent of stroke. However, these techniques achieve simply a baseline study of ischemia occurred and can deliver only a snapshot of brain parenchyma and vessels. Furthermore, their rapid and actual availability, especially in primary hospitals, and their dynamic capabilities and predictive values for further infarction are poor with critically ill patients have to be repeatedly transferred to the scanning unit for each measurement. Whereas CT examination is associated with x-ray radiation and may miss early detection of stroke, MRI is associated with higher costs and not generally routinely and around-the clock available in all the hospitals. Therefore, a simple, fast, repeatable, non-hazardous, and non-invasive dynamic bedside tool for the detection of acute brain tissue hypoperfusion and monitoring for potential further infarction or efficacy of thrombolysis either by systemic intravenous thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) or by selective intraarterial fibrinolysis and mechanical recanalization, both combined with or without bridging after acute ischemic stroke, is strongly needed.
A promising alternative method of diagnosing stroke represents contrast-enhanced ultrasound perfusion imaging (UPI). What makes UPI so valuable is the advantage of repeatedly and non-invasively detecting brain tissue at risk for infarction by dynamic direct brain tissue perfusion assessment and not by surrogate parameters, like blood flow velocity or vessel diameter. Because of the possibility to screen and repeatedly measure the state of perfusion, the chances increase to diagnose and monitor ischemic stroke and to define the appropriate window for treatment. The perfusion analysis would also allow determination of treatment results and guidance of rapid and adequate further therapy.
Therefore, the present pilot study in 40 patients is initiated. The objectives of this observational diagnostic cohort trial are to evaluate feasibility and practicability of repeated bedside assessments by contrast enhanced UPI in acute ischemic stroke patients and to assess whether UPI can detect alterations in brain tissue perfusion before and after recanalising therapy of strokes. Assessment of cerebral perfusion by CT or MRI serves as reference and its results are compared to UPI data.
Detailed description
Background
Stroke is a personal, familial and social disaster. Apart from development of stroke prevention and treatment strategies, the mainstay of stroke research remains new-product development and improvement of current imaging tools for diagnosis, monitoring and follow-up of stroke patients. For initial neuroradiological work-up, usually computed tomography (CT) or magnetic resonance imaging (MRI) are used to detect presence or absence, effective state and extent of stroke. However, their rapid and actual availability, especially in primary hospitals, and their dynamic capabilities and predictive values for further infarction are poor. Currently cerebral CT-perfusion (CTP) imaging can be regarded as the gold standard for assessing tissue hypoperfusion in this setting. It employs, however, both contrast agent and X-ray exposition and patients have to be repeatedly transferred to the scanning unit for each measurement. Therefore, a fast, simple, repeatable, non-hazardous and non-invasive dynamic bedside tool for the detection of acute brain tissue hypoperfusion and monitoring for potential further infarction or efficacy of thrombolysis after ischemic stroke is strongly needed.
Socioeconomic importance of stroke Stroke is the first cause of acquired disability, the second cause of dementia and the third cause of death worldwide, and its associated socio-economic costs are astronomic. The burden of stroke is likely to increase, given the aging of the population and the growing incidence of many vascular risk factors. Therefore, rational and effective diagnostic and therapeutic management in stroke patients has potential high long-term clinical and economic consequences.
Current standard therapy after acute ischemic stroke According to the cause of stroke and apart from medical treatment and surgical options in selected cases, the mainstay of therapeutic management of acute ischemic stroke itself usually remain systemic intravenous thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) or selective intraarterial fibrinolysis and mechanical recanalization, both with or without bridging (combined intravenous and intraarterial thrombolysis). In this regard, reperfusion therapy is the only proven treatment for acute ischemic stroke.
Current problems in diagnosis and monitoring of stroke patients At present, CT and MRI are usually applied for diagnosis and follow-up of stroke. However, both CT and MRI achieve simply a baseline study of ischemia occurred and can deliver only a snapshot of brain parenchyma and vessels. Furthermore, whereas CT examination is associated with x-ray radiation and may miss early detection of stroke, MRI is associated with higher costs and is not generally routinely and around-the clock available in all the hospitals. Both imaging methods require transportation and intensive care of the often critically ill patients to the scanning unit for each measurement.
There is unanimous agreement about the need for a bedside assessment of the status of tissue perfusion. Invasive cerebral angiography is indicated in cases of further evaluation of stroke causes and intended endovascular therapy.
Potential of ultrasound perfusion imaging (UPI) What makes contrast enhanced UPI so valuable is the possibility to repeatedly and non-invasively detect brain tissue at risk for infarction by direct brain tissue perfusion assessment and not by surrogate parameters, like blood flow velocity or vessel diameter. Because of the possibility to screen and repeatedly measure the state of perfusion, the chances increase to diagnose and monitor ischemic stroke and to define the appropriate window for treatment. The perfusion analysis would also allow determination of treatment results and guidance of rapid and adequate further therapy.
Objective
The objective of the present study is to assess whether cerebral hypoperfusion can be detected by ultrasound perfusion imaging (UPI) before and after treatment of acute ischemic stroke.
Methods
Patients with acute middle cerebral artery (MCA) territory ischemic stroke are evaluated for potential thrombolysis/thrombectomy according to the Bernese neurologic stroke algorithm. An experienced neurosonographer performs contrast-enhanced ultrasound perfusion imaging (UPI) after prospective study enrollment and specific stroke CT/MRI with perfusion measurement. Clinical status is documented by use of the NIHSS on admission /first day after the intervention. UPI and CT/MRI perfusion data is analyzed. Two different quantification algorithms, standard versus patient-adjusted, are used. Data is analyzed by descriptive statistics using the mean, median and standard deviation of the ROIs. Sensitivity and specificity analyses are calculated using Pearson's chi-square test. Receiver-operator characteristic curves are calculated for UPI/perfusion MRI/CT parameters. Pearson correlation is used to evaluate correlations between absolute values of UPI and MRI TTP data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | – | Other: Ultrasound perfusion imagingPatients with Stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The trial population comprises of patients with acute ischemic stroke treated at the University Hospital Bern.
Key inclusion criteria (4 listed)
- All patients with an indication for iv thrombolysis or endovascular treatment according to the current stroke guidelines of the University Hospital Bern
- Age ≥18
- Written informed consent by patient or next of kin
- Signed consent of independent physician
Key exclusion criteria (4 listed)
- Positive pregnancy test and breast feeding
- Acute coronary syndromes, severe ischemic heart disease (requiring revascularization), severe aortic and mitral valve disease, severe congestive heart failure (NYHA >III/IV)
- Severe pulmonary or renal dysfunction
- Known allergy or adverse reaction to contrast material
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 |
|---|---|---|
| Ultrasound perfusion imagingDynamic perfusion imaging of brain parenchyma with modern ultrasound is possible with the use of ultrasound contrast media that serve as echo signal amplifier. | Other | All study participants |
Primary outcome
Number of participants with detection of cerebral hypoperfusion before and after thrombolytic treatment and correlation to established diagnostic gold standard CT- or MRI-perfusion studies by measurement of time to peak values
Time frame: 1 day after intervention
2 secondary outcomes
Number of Patients with Adverse Events as a Measure of Safety and Tolerability and detection of early clinical outcome by NIHSS
Time frame: 1 day after intervention
Quantitative analysis of metric parameters of UPI
Time frame: 1 day after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Background: PubMed 15548506Beck J, Raabe A, Lanfermann H, Seifert V, Weidauer S. Tissue at risk concept for endovascular treatment of severe vasospasm after aneurysmal subarachnoid haemorrhage. J Neurol Neurosurg Psychiatry. 2004 Dec;75(12):1779-81. doi: 10.1136/jnnp.2004.036921.
- Background: PubMed 17219826Beck J, Raabe A, Lanfermann H, Berkefeld J, De Rochemont Rdu M, Zanella F, Seifert V, Weidauer S. Effects of balloon angioplasty on perfusion- and diffusion-weighted magnetic resonance imaging results and outcome in patients with cerebral vasospasm. J Neurosurg. 2006 Aug;105(2):220-7. doi: 10.3171/jns.2006.105.2.220.
- Background: PubMed 16528172Beck J, Raabe A, Lanfermann H, Seifert V, Weidauer S. Perfusion-weighted magnetic resonance imaging in patients with vasospasm: a useful new tool in the management of patients with subarachnoid hemorrhage. Neurosurgery. 2006 Mar;58(3):E590; author reply E590. doi: 10.1227/01.NEU.0000207963.98939.7B. No abstract available.
- Background: PubMed 16121127Eyding J, Krogias C, Schollhammer M, Eyding D, Wilkening W, Meves S, Schroder A, Przuntek H, Postert T. Contrast-enhanced ultrasonic parametric perfusion imaging detects dysfunctional tissue at risk in acute MCA stroke. J Cereb Blood Flow Metab. 2006 Apr;26(4):576-82. doi: 10.1038/sj.jcbfm.9600216.
- Background: PubMed 15031454Seidel G, Meyer-Wiethe K, Berdien G, Hollstein D, Toth D, Aach T. Ultrasound perfusion imaging in acute middle cerebral artery infarction predicts outcome. Stroke. 2004 May;35(5):1107-11. doi: 10.1161/01.STR.0000124125.19773.40. Epub 2004 Mar 18.
- Background: PubMed 14739406Wiesmann M, Meyer K, Albers T, Seidel G. Parametric perfusion imaging with contrast-enhanced ultrasound in acute ischemic stroke. Stroke. 2004 Feb;35(2):508-13. doi: 10.1161/01.STR.0000114877.58809.3D. Epub 2004 Jan 22.
- Background: PubMed 21364598Kern R, Diels A, Pettenpohl J, Kablau M, Brade J, Hennerici MG, Meairs S. Real-time ultrasound brain perfusion imaging with analysis of microbubble replenishment in acute MCA stroke. J Cereb Blood Flow Metab. 2011 Aug;31(8):1716-24. doi: 10.1038/jcbfm.2011.14. Epub 2011 Mar 2.
- Background: PubMed 15375306Eyding J, Krogias C, Meves S, Przuntek H, Postert T. Quantitative ultrasonographic evaluation of cerebral perfusion in acute stroke is possible. Stroke. 2004 Nov;35(11):2432-3; author reply 2433. doi: 10.1161/01.STR.0000143731.48504.7d. Epub 2004 Sep 16. No abstract available.
- Background: PubMed 17337111Engelhardt M, Hansen C, Eyding J, Wilkening W, Brenke C, Krogias C, Scholz M, Harders A, Ermert H, Schmieder K. Feasibility of contrast-enhanced sonography during resection of cerebral tumours: initial results of a prospective study. Ultrasound Med Biol. 2007 Apr;33(4):571-5. doi: 10.1016/j.ultrasmedbio.2006.10.007.
- Background: PubMed 20420978Kopp R, Zurn W, Weidenhagen R, Meimarakis G, Clevert DA. First experience using intraoperative contrast-enhanced ultrasound during endovascular aneurysm repair for infrarenal aortic aneurysms. J Vasc Surg. 2010 May;51(5):1103-10. doi: 10.1016/j.jvs.2009.12.050.
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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.
Jürgen Beck, Prof. Dr. med. principal investigator
Department of Neurosurgery, Bern University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Insel Gruppe AG, University Hospital Bern 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 11 Jul 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with detection of cerebral hypoperfusion before and after thrombolytic treatment and correlation to established diagnostic gold standard CT- or MRI-perfusion studies by measurement of time to peak values (time frame: 1 day after intervention). 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 NCT02415972, which also lists 10 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 11 Jul 2016.