Cerebral Dynamic Perfusion Study With Spectral CT in Patients Suspected of Stroke

Stroke, Acute Clinical Trial

— AVC_AIGUS  

Official title:

Cerebral Dynamic Perfusion Study With Spectral CT in Patients Suspected of Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03948425
• Other study ID #: AVC AIGUS
• Secondary ID: 2017/12AVR/209
• Status: Completed
• Phase: N/A
• Start date: June 8, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: October 2020
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• Generate a dynamic mapping of the distribution of iodine within the cerebral parenchyma in the patient suspected of acute ischemic disorder with the CT spectral scanner.

• Correlate the anomalies of iodine mapping to the other parameters acquired during the classic dynamic infusion phase to define the ischemic area (MTT higher and rCBV normal) versus infarcted zone (MTT higher and rCBV decreased)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 95 Years

Eligibility

Inclusion Criteria:

• Clinical suspicion of hyperacute stroke (6 hours after onset of symptoms)

• Age between 50 and 95 years

• Weight: between 65 and 95 kg

Exclusion Criteria:

• Documented or suspected allergy to IV iodinated contrast media

• Renal impairment with creatinine clearance <60 ml / min

• Hemorrhagic lesions or vascular abnormalities demonstrated on CT before contrast injection

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Radiation:
• spectral CT
Head spectral CT

Locations

Country	Name	City	State
Belgium	Cliniques universitaires saint Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral Blood Volume (CBV)	CBV is measured in units of milliliters of blood per 100 g of brain and is defined as the volume of flowing blood for a given volume of brain.	from start of the study procedure (CT scan) through end of study procedure (from 15 minutes to 30 minutes)
Primary	Mean Transit Time (MTT)	MTT is measured in seconds and defined as the average amount of time it takes blood to transit through the given volume of brain.	rom start of the study procedure (CT scan) through end of study procedure (from 15 minutes to 30 minutes)
Primary	Cerebral Blood Flow (CBF)	CBF is measured in units of milliliters of blood per 100 g of brain tissue per minute and is defined as the volume of flowing blood moving through a given volume of brain in a specific amount of time.	rom start of the study procedure (CT scan) through end of study procedure (from 15 minutes to 30 minutes)