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Clinical Trials/NCT03948425
NCT03948425CompletedNot Applicable

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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 site in 1 country28 target enrollmentStarted: June 8, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
28
Locations
1
Primary Endpoint
Cerebral Blood Volume (CBV)

Study Overview

Brief 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)

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
50 Years to 95 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Stroke

Experimental

Clinical suspicion of hyperacute stroke (6 hours after onset of symptoms):Intervention 'spectral CT'

Intervention: spectral CT (Radiation)

Outcomes

Primary Outcomes

Cerebral Blood Volume (CBV)

Time Frame: from start of the study procedure (CT scan) through end of study procedure (from 15 minutes to 30 minutes)

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.

Mean Transit Time (MTT)

Time Frame: rom start of the study procedure (CT scan) through end of study procedure (from 15 minutes to 30 minutes)

MTT is measured in seconds and defined as the average amount of time it takes blood to transit through the given volume of brain.

Cerebral Blood Flow (CBF)

Time Frame: rom start of the study procedure (CT scan) through end of study procedure (from 15 minutes to 30 minutes)

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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