Ischemic Stroke Clinical Trial
— PerCEUSOfficial title:
Quantification of Cerebral Perfusion at the Patient's Bedside When Performing Contrast-enhanced Ultrasound in Neurointensive Care Patients
NCT number | NCT05893407 |
Other study ID # | APHP230489 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 21, 2023 |
Est. completion date | July 2025 |
The objective of the study is to assess brain tissue perfusion by contrast-enhanced ultrasound perfusion imaging (PerCEUS) in acute brain injuries. More precisely, it aims : - to evaluate the heterogeneity of brain perfusion and thus diagnose brain tissue hypoperfusion with contrast-enhanced ultrasound. - to correlate contrast-enhanced ultrasound with perfusion measurements by usual multimodal monitoring.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | July 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age =18 - Intensive care unit admission for acute brain injury - Proven acute brain injury by CT and/or MRI - Requiring a contrast ultrasound imaging - Informed consent of patient or relative Exclusion Criteria: - Pregnancy - Not sufficient temporal window - Contraindications to Sonovue ® : acute coronary syndromes, severe ischemic heart disease (requiring revascularization), pulmonary arterial hypertension > 90 mmHg, right-left shunt, ARDS, dobutamine's use, known allergy or adverse reaction to Sonovue® - Patient on State Medical Assistance |
Country | Name | City | State |
---|---|---|---|
France | Lariboisière Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Bilotta F, Robba C, Santoro A, Delfini R, Rosa G, Agati L. Contrast-Enhanced Ultrasound Imaging in Detection of Changes in Cerebral Perfusion. Ultrasound Med Biol. 2016 Nov;42(11):2708-2716. doi: 10.1016/j.ultrasmedbio.2016.06.007. Epub 2016 Jul 27. — View Citation
Eyding J, Fung C, Niesen WD, Krogias C. Twenty Years of Cerebral Ultrasound Perfusion Imaging-Is the Best yet to Come? J Clin Med. 2020 Mar 17;9(3):816. doi: 10.3390/jcm9030816. — View Citation
Eyding J, Krogias C, Wilkening W, Postert T. Detection of cerebral perfusion abnormalities in acute stroke using phase inversion harmonic imaging (PIHI): preliminary results. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):926-9. doi: 10.1136/jnnp.2003.026195. — View Citation
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. — View Citation
Vinke EJ, Kortenbout AJ, Eyding J, Slump CH, van der Hoeven JG, de Korte CL, Hoedemaekers CWE. Potential of Contrast-Enhanced Ultrasound as a Bedside Monitoring Technique in Cerebral Perfusion: a Systematic Review. Ultrasound Med Biol. 2017 Dec;43(12):2751-2757. doi: 10.1016/j.ultrasmedbio.2017.08.935. Epub 2017 Sep 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of the heterogeneity of brain perfusion by time-to-peak (TPI) measurement | Comparison between time-to-peak (TPI) intensities measured in ROIs in each area by PerCEUS | 30 minutes after PerCEUS | |
Primary | Evaluation of the heterogeneity of brain perfusion by peak-intensities (PI) measurement | Comparison between peak-intensities (PI) measured in ROIs in each area by PerCEUS | 30 minutes after PerCEUS | |
Secondary | Correlation between PerCEUS parameters and cerebral perfusion as assessed by ICP and MAP | Correlations test between TPI/PI and ICP/CPP/MAP | 30 minutes after PerCEUS | |
Secondary | Correlation between PerCEUS parameters and cerebral perfusion as assessed by TCD | Correlations test between TPI/PI and MFV | 30 minutes after PerCEUS | |
Secondary | Correlation between PerCEUS parameters and cerebral perfusion as assessed by NIRS | orrelations test between TPI/PI and rSO2 | 30 minutes after PerCEUS | |
Secondary | Correlation between PerCEUS parameters and cerebral perfusion as assessed by SjvO2 | Correlations test between TPI/PI and SjvO2 | 30 minutes after PerCEUS |
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