Contrast enhanced ultrasound to measure cerebral blood flow

Conditions: acute brain injury
acute cerebral ischemia
10007963

Registration Number: NL-OMON44637

Lead Sponsor: IC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 11

Inclusion Criteria

Healthy men or women of 18-35 years old

Exclusion Criteria

- Hypersensitivity to the active substance(s) or to any of the excipients in SonoVue
- Right-to-left shunt cardiac shunt
- Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg)
- Uncontrolled systemic hypertension
- Pregnancy
- Lactation
- Participation in another clinical trial within 3 months prior to the experimental day.
- History, signs, or symptoms of cardiovascular disease or pulmonary disease
- History, signs or symptoms of neurological disease

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter is the reproducibility of the CEUS bolus kinetics using<br /><br>the simultaneous measurement in the internal carotid artery and middle cerebral<br /><br>artery. Measurements of the brain will be performed at normoventilation by a<br /><br>single investigator, the differences between the 3 subsequent measurements will<br /><br>be compared (all measurements performed within 90 minutes). A difference<br /><br>between the measurements of more than 10% is considered to imply poor<br /><br>reproducibility. As a control, the reproducib¡lity of measurement of the flow<br /><br>velocity in the ipsilateral middle cerebral artery will be assessed. The<br /><br>investigator performing the test is blinded for the results, as determination<br /><br>of flow is only possible after offline<br /><br>analysis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are<br /><br>- Variability of the CEUS technique without the baseline measurement at the<br /><br>internal carotid artery<br /><br>- Correlation between flow measurements using the CEUS bolus technique (using<br /><br>the signal in the internal carotid artery as a baseline signal) with CBF<br /><br>measured with transcranial Doppler in normal en decreased CBF<br /><br>- Correlation between flow measurements using the CEUS bolus techn¡que (not<br /><br>using the signal in the internal carotid artery as a baseline signal) with CBF<br /><br>measured with transcranial Doppler in normal en decreased CBF</p><br>