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

April 22, 2021 updated by: University Hospital Inselspital, Berne

Contrast Enhanced Ultrasound Imaging for Cerebral Perfusion Measurement in Cerebral Vasospasm After Subarachnoid Hemorrhage

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

Study Overview

Status

Terminated

Conditions

Detailed Description

The aim of the study is to assess brain tissue perfusion by ultrasound perfusion imaging (UPI).

The specific aim is to diagnose brain tissue hypoperfusion leading to infarction due to CVS with ultrasound perfusion imaging (UPI) and to correlate it with the gold standard of diagnosis of brain infarcts, i.e. with MRI and CT. According to contrast enhanced UPI brain tissue will be classified as (1) normal, i.e. not leading to tissue infarction, (2) as hypoperfused, i.e. functionally impaired and prone to DIND and to infarction, or (3) non-perfused. Thus, temporary hypoperfusion that may be resolved by therapy or spontaneously, not leading to tissue infarction shall be assessed. This strategy will lead to guiding therapy by UPI.

Questionnaire:

  • to assess cerebral perfusion in patients with SAH by contrast enhanced UPI
  • to assess specificity and sensitivity, as well as positive and negative predictive values of contrast enhanced UPI for detection of brain tissue misery perfusion leading to infarction
  • to evaluate feasibility and practicability of repeated bed-side assessments of UPI
  • to test whether treatment-effects like induced hypertension, balloon-dilation, or intra-arterial nimodipine infusion can be detected and quantified by contrast enhanced UPI
  • to analyze whether TCD or contrast enhanced UPI is superior for screening of CVS and detection of cerebral infarcts (vessel vs. tissue assessment)
  • to correlate contrast enhanced UPI with perfusion measurements by CT-perfusion imaging

Ultrasound perfusion imaging (UPI) is able to detect cerebral hypoperfusion that can result in cerebral infarction in a clinical setting. As reference the incidence of cerebral infarcts is assessed by CT- and MR-imaging and cerebral perfusion is analyzed by CT-perfusion (CTP) imaging.

The day of the ictus (SAH) is defined as day 0. The ultrasound examinations will be performed at

  • Day 0-4: one baseline UPI study will be performed. This time period (0-4) is set as baseline, because this baseline investigation will be performed before vasospasm develops. The current policy of early aneurysm treatment results in clipping or coiling of patients within 24-48 hours. The relevant phase of CVS, however, starts on day 4 to 5 after the ictus. The already established routine protocol with early CT and CTP imaging after aneurysm treatment allows differentiation between infarcts due to the procedure of aneurysm clipping or coiling, bleeding, edema, or surgical contusions from cerebral infarcts due to CVS that develop later on. This early routine CT imaging includes a CT-perfusion study on post-op day 1, serving as reference for the ultrasound perfusion measurements.
  • Day 5-14: during the term with the highest risk for CVS, a UPI study will be performed every second day.

  • Several events trigger additional UPI studies:

    • angiography (scheduled or emergency)
    • endovascular intervention (angioplasty or intraarterial nimodipine infusion)
    • CT or MRI study with new infarcts
    • Development of DIND or reversal of DIND
    • in case of placement of an intracerebral microprobe (rCBF or ptiO2) an UPI study will be performed when significant changes (rCBF drop below 20ml/100g/min or below 60% of baseline, ptiO2 drop below 10mmHg or below 60% of baseline) occur.

Currently all patients are scanned by MRI and or CT several times in the course of the disease. Each imaging study serves as reference for UPI.

During day 5-14 high risk patients (Fisher grade 3, or TCD > 150 cm/sec, or new deficit) receive one CT-perfusion study between day 7 and 11 (period of highest risk).

During day 5-14 patients with proven CVS (angiography) will receive two CT-perfusion studies, one at day 7, and one at day 11, or at the time when new deficits or infarcts evolve. Additional about 20% of patients will get MRI including perfusion weighted imaging (PWI). In these patients misery perfusion as detected by PWI serves as reference for UPI.

The actual UPI measurement takes place at the bedside, is performed by the study physician, and takes about 15 -30 minutes.

The trial duration per patient is 14 days during the initial hospitalization.

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Department of Neurosurgery, University Hospital Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Ultrasound perfusion imaging
Measuring methods of UPI with phase inversion harmonic imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 days after ictus

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between UPI parameters and cerebral perfusion as assessed by CT-perfusion
Time Frame: Within 14 days after ictus
Within 14 days after ictus
Correlation between UPI parameters and cerebral perfusion as assessed by MRI-perfusion
Time Frame: Within 14 days after ictus
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
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
Within 14 days after ictus

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Jürgen Beck, MD, University Hospital Inselspital, Berne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 23, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SONO SAB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Subarachnoid Hemorrhage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe