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

Primary Purpose

Stroke, Acute

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
spectral CT
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke, Acute

Eligibility Criteria

50 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cliniques universitaires saint Luc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stroke

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 17, 2018
Last Updated
October 30, 2020
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT03948425
Brief Title
Cerebral Dynamic Perfusion Study With Spectral CT in Patients Suspected of Stroke
Acronym
AVC_AIGUS
Official Title
Cerebral Dynamic Perfusion Study With Spectral CT in Patients Suspected of Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stroke
Arm Type
Experimental
Arm Description
Clinical suspicion of hyperacute stroke (6 hours after onset of symptoms):Intervention 'spectral CT'
Intervention Type
Radiation
Intervention Name(s)
spectral CT
Intervention Description
Head spectral CT
Primary Outcome Measure Information:
Title
Cerebral Blood Volume (CBV)
Description
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.
Time Frame
from start of the study procedure (CT scan) through end of study procedure (from 15 minutes to 30 minutes)
Title
Mean Transit Time (MTT)
Description
MTT is measured in seconds and defined as the average amount of time it takes blood to transit through the given volume of brain.
Time Frame
rom start of the study procedure (CT scan) through end of study procedure (from 15 minutes to 30 minutes)
Title
Cerebral Blood Flow (CBF)
Description
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.
Time Frame
rom start of the study procedure (CT scan) through end of study procedure (from 15 minutes to 30 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Coche, MD-PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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