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

This study is currently recruiting participants.
Verified September 2017 by University Hospital Inselspital, Berne
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907879
First Posted: September 20, 2016
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
  Purpose

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

Condition
Subarachnoid Hemorrhage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contrast Enhanced Ultrasound Imaging for Cerebral Perfusion Measurement in Cerebral Vasospasm After Subarachnoid Hemorrhage

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Detection of cerebral hypoperfusion leading to either infarcts, neurological deficits, or initiation of rescue therapy [ Time Frame: 14 days after ictus ]
    (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


Secondary Outcome Measures:
  • Correlation between UPI parameters and cerebral perfusion as assessed by CT-perfusion [ Time Frame: Within 14 days after ictus ]
  • Correlation between UPI parameters and cerebral perfusion as assessed by MRI-perfusion [ Time Frame: Within 14 days after ictus ]
  • Correlation between UPI parameters and flow velocities in the middle cerebral artery as measured by TCD [ Time Frame: Within 14 days after ictus ]
  • Correlation between UPI parameters with vessel diameters of the MCA as assessed by DSA [ Time Frame: Within 14 days after ictus ]

Estimated Enrollment: 100
Study Start Date: July 2013
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ultrasound perfusion imaging
Measuring methods of UPI with phase inversion harmonic imaging

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907879


Contacts
Contact: Jürgen Beck, MD +41316322409 juergen.beck@insel.ch
Contact: Werner Z`Graggen, MD +41316322409 werner.zgraggen@insel.ch

Locations
Switzerland
Department of Neurosurgery, University Hospital Bern Recruiting
Bern, Switzerland, 3010
Contact: Jürgen Beck, MD    031 632 2409    juergen.beck@insel.ch   
Contact: Werner Z`Graggen, MD    031 632 2409    werner.zgraggen@insel.ch   
Principal Investigator: Jürgen Beck, MD         
Sub-Investigator: Werner Z`Graggen, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Jürgen Beck, MD University Hospital Inselspital, Berne
  More Information

Publications:

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02907879     History of Changes
Other Study ID Numbers: SONO SAB
First Submitted: September 16, 2016
First Posted: September 20, 2016
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by University Hospital Inselspital, Berne:
Subarachnoid Hemorrhage
Ultrasound perfusion imaging
cerebral hypoperfusion
vasospasm
DIND
infarction

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases