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Contrast enhanced ultrasound to measure cerebral blood flow

Contrast enhanced ultrasound to measure cerebral blood flow - Contrast enhanced ultrasound to measure cerebral blood flow

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44637
Enrollment
11
Registered
2017-11-06
Start date
2017-10-01
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute brain injury acute cerebral ischemia

Interventions

None listed

Sponsors

IC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy men or women of 18-35 years old

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)