Contrast Enhanced Ultrasound Imaging for Cerebral Perfusion Measurement in Cerebral Vasospasm After SAH

NCT02907879 | Terminated

• 1 other identifier: SONO SAB
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to assess brain tissue perfusion by ultrasound perfusion imaging. Specifically

• to diagnose brain tissue hypoperfusion due to CVS with contrast enhanced UPI and to assess specificity and sensitivity, and predictive values for detection of brain tissue hypoperfusion leading to infarction
• to test whether treatment-effects by induced hypertension, balloon-dilatation, or intra-arterial nimodipine infusion can be detected and quantified by UPI

Conditions

Subarachnoid Hemorrhage

Keywords

Subarachnoid Hemorrhage; Ultrasound perfusion imaging; cerebral hypoperfusion; vasospasm; DIND; infarction

Outcome Measures

Primary Outcomes (1)

• Detection of cerebral hypoperfusion leading to either infarcts, neurological deficits, or initiation of rescue therapy

  (1) normal, i.e. with a perfusion delay \< 2 sec, (2) hypoperfusion, i.e. with a perfusion delay ≥ 2sec and \< 6 sec, and (3) no perfusion, i.e. with a perfusion delay ≥ 6 sec as compared with the average of the 2 thalamic territories of the unaffected side

  14 days after ictus

Secondary Outcomes (4)

• Correlation between UPI parameters and cerebral perfusion as assessed by CT-perfusion

  Within 14 days after ictus

• Correlation between UPI parameters and cerebral perfusion as assessed by MRI-perfusion

  Within 14 days after ictus

• Correlation between UPI parameters and flow velocities in the middle cerebral artery as measured by TCD

  Within 14 days after ictus

• Correlation between UPI parameters with vessel diameters of the MCA as assessed by DSA

  Within 14 days after ictus

Study Arms (1)

Ultrasound perfusion imaging

Measuring methods of UPI with phase inversion harmonic imaging

Eligibility Criteria

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

Study Population

All consecutive patients with aneurysmal SAH admitted to the Departments of Neurosurgery, Neurology, or Intensive Care Medicine, will be screened for enrollment in the study

You may qualify if:

• Proven SAH (CT or lumbar puncture)
• Proven aneurysm (digital subtraction angiography or CT-angiography)
• Age \>18
• Informed consent of patient or relative

You may not qualify if:

• Pregnancy and breast feeding
• Acute coronary syndromes, severe ischemic heart disease (requiring revascularisation), 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, University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (14)

• Reitmeir R, Eyding J, Oertel MF, Wiest R, Gralla J, Fischer U, Giquel PY, Weber S, Raabe A, Mattle HP, Z'Graggen WJ, Beck J. Is ultrasound perfusion imaging capable of detecting mismatch? A proof-of-concept study in acute stroke patients. J Cereb Blood Flow Metab. 2017 Apr;37(4):1517-1526. doi: 10.1177/0271678X16657574. Epub 2016 Jan 1.

  PMID: 27389180 BACKGROUND

• de Rooij NK, Linn FH, van der Plas JA, Algra A, Rinkel GJ. Incidence of subarachnoid haemorrhage: a systematic review with emphasis on region, age, gender and time trends. J Neurol Neurosurg Psychiatry. 2007 Dec;78(12):1365-72. doi: 10.1136/jnnp.2007.117655. Epub 2007 Apr 30.

  PMID: 17470467 BACKGROUND

• Feigin VL, Lawes CM, Bennett DA, Barker-Collo SL, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol. 2009 Apr;8(4):355-69. doi: 10.1016/S1474-4422(09)70025-0. Epub 2009 Feb 21.

  PMID: 19233729 BACKGROUND

• Johnston SC, Selvin S, Gress DR. The burden, trends, and demographics of mortality from subarachnoid hemorrhage. Neurology. 1998 May;50(5):1413-8. doi: 10.1212/wnl.50.5.1413.

  PMID: 9595997 BACKGROUND

• Weidauer S, Lanfermann H, Raabe A, Zanella F, Seifert V, Beck J. Impairment of cerebral perfusion and infarct patterns attributable to vasospasm after aneurysmal subarachnoid hemorrhage: a prospective MRI and DSA study. Stroke. 2007 Jun;38(6):1831-6. doi: 10.1161/STROKEAHA.106.477976. Epub 2007 Apr 19.

  PMID: 17446425 BACKGROUND

• Vergouwen MD, Vermeulen M, Roos YB. Effect of nimodipine on outcome in patients with traumatic subarachnoid haemorrhage: a systematic review. Lancet Neurol. 2006 Dec;5(12):1029-32. doi: 10.1016/S1474-4422(06)70582-8.

  PMID: 17110283 BACKGROUND

• Raabe A, Beck J, Keller M, Vatter H, Zimmermann M, Seifert V. Relative importance of hypertension compared with hypervolemia for increasing cerebral oxygenation in patients with cerebral vasospasm after subarachnoid hemorrhage. J Neurosurg. 2005 Dec;103(6):974-81. doi: 10.3171/jns.2005.103.6.0974.

  PMID: 16381183 BACKGROUND

• Aaslid R, Huber P, Nornes H. Evaluation of cerebrovascular spasm with transcranial Doppler ultrasound. J Neurosurg. 1984 Jan;60(1):37-41. doi: 10.3171/jns.1984.60.1.0037.

  PMID: 6689726 BACKGROUND

• 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, 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

• Chapman F, Morrissey R, McDermott S, Cahours X, Verron T, Taverner V, Stevenson M, Nahde T. Evaluation of high-nicotine oral products shows potential to reduce tobacco-related harm by offering satisfying alternatives. Sci Rep. 2025 Oct 3;15(1):34636. doi: 10.1038/s41598-025-21812-x.

  PMID: 41044396 DERIVED

• Fung C, Heiland DH, Reitmeir R, Niesen WD, Raabe A, Eyding J, Schnell O, Rolz R, Z Graggen WJ, Beck J. Ultrasound Perfusion Imaging for the Detection of Cerebral Hypoperfusion After Aneurysmal Subarachnoid Hemorrhage. Neurocrit Care. 2022 Aug;37(1):149-159. doi: 10.1007/s12028-022-01460-z. Epub 2022 Feb 24.

  PMID: 35211837 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Infarction

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Necrosis

Study Officials

• Jürgen Beck, MD

  Insel Gruppe AG, 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: September 16, 2016
• First Posted: September 20, 2016
• Study Start: July 1, 2013
• Primary Completion: January 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)