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

October 30, 2020 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  • 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stroke
Clinical suspicion of hyperacute stroke (6 hours after onset of symptoms):Intervention 'spectral CT'
Radiation: spectral CT
Head spectral CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from start of the study procedure (CT scan) through end of study procedure (from 15 minutes to 30 minutes)
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.
rom start of the study procedure (CT scan) through end of study procedure (from 15 minutes to 30 minutes)
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.
rom start of the study procedure (CT scan) through end of study procedure (from 15 minutes to 30 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Emmanuel Coche, MD-PhD, Cliniques universitaires Saint-Luc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2017

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

May 9, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 30, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVC AIGUS
  • 2017/12AVR/209 (Other Identifier: CEHF)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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