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

NCT03948425 | Completed

• 2 other identifiers: AVC AIGUS2017/12AVR/209
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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)

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (1)

Stroke

EXPERIMENTAL

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

Radiation: spectral CT

Interventions

spectral CT RADIATION

Head spectral CT

Stroke

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical suspicion of hyperacute stroke (6 hours after onset of symptoms)
• Age between 50 and 95 years
• Weight: between 65 and 95 kg

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires saint Luc

Brussels, 1200, Belgium

Location

Related Publications (1)

• Duprez T, Vlassenbroek A, Peeters A, Poncelet PA, Levecque E, Austein F, Pahn G, Nae Y, Abdallah S, Coche E. Preliminary experience of CT imaging of the ischaemic brain penumbra through spectral processing of multiphasic CTA datasets. Sci Rep. 2023 Jul 15;13(1):11431. doi: 10.1038/s41598-023-38370-9.

  PMID: 37454162 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Emmanuel Coche, MD-PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: May 14, 2019
• Study Start: June 8, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)