Dynamic Contrast-enhanced Ultrasound Imaging for Cerebral Perfusion Measurement in Acute Ischemic Stroke

NCT02415972 | Completed

• 1 other identifier: 179/12
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Ischemic Stroke

Keywords

ultrasound imaging; acute ischemic stroke; cerebral perfusion measurement in acute ischemic stroke

Outcome Measures

Primary Outcomes (1)

• 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

  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

  1 day after intervention

• Quantitative analysis of metric parameters of UPI

  1 day after intervention

Study Arms (1)

All study participants

Patients with Stroke

Other: Ultrasound perfusion imaging

Interventions

Ultrasound perfusion imaging OTHER

Dynamic perfusion imaging of brain parenchyma with modern ultrasound is possible with the use of ultrasound contrast media that serve as echo signal amplifier.

All study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The trial population comprises of patients with acute ischemic stroke treated at the University Hospital Bern.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Neurosurgery, Bern University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (10)

• 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.

  PMID: 15548506 BACKGROUND

• Beck 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.

  PMID: 17219826 BACKGROUND

• Beck 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.

  PMID: 16528172 BACKGROUND

• Eyding 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.

  PMID: 16121127 BACKGROUND

• Seidel 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.

  PMID: 15031454 BACKGROUND

• Wiesmann 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.

  PMID: 14739406 BACKGROUND

• Kern 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.

  PMID: 21364598 BACKGROUND

• Eyding 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.

  PMID: 15375306 BACKGROUND

• Engelhardt 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.

  PMID: 17337111 BACKGROUND

• Kopp 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.

  PMID: 20420978 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jürgen Beck, Prof. Dr. med.

  Department of Neurosurgery, Bern University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 14, 2015
• Study Start: October 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2016
• Last Updated: July 11, 2016

Record last verified: 2016-07

Locations

CH (1)