NCT00708188

Brief Summary

This is a prospective study including acute ischemic stroke patients aged 18 to 90. Multidetector raw CT is performed in acute ischemic stroke patients. Heart, neck vessels and brain arteries are studied during the same acquisition. Results are compared with the standard methods including transesophageal echocardiography (TEE), Doppler ultrasound (DUS) and MR angiography (MRA) of neck vessels. The main criteria is the ability of CT to classify the stroke etiology correctly according to the TOAST classification in comparison with the standard methods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 28, 2019

Status Verified

July 1, 2013

Enrollment Period

5.1 years

First QC Date

June 30, 2008

Last Update Submit

May 23, 2019

Conditions

Keywords

Stroke, ischemic, etiology, TOAST, CT, multidetector

Outcome Measures

Primary Outcomes (1)

  • Ability of CT to classify the stroke etiology correctly (TOAST classification) in comparison to reference methods (MRA, DUS, TEE)

    classify the stroke etiology

Secondary Outcomes (1)

  • Ability of CT to detect the source of stroke in each etiological group. Reliability of CT in quantitative measures of artery stenosis, aortic atheroma, heart thrombus, heart tumors). Tolerance of CT

    detect the source of stroke

Study Arms (1)

Multidetector raw CT

EXPERIMENTAL
Device: Multidetector raw CT

Interventions

Multidetector raw CT

Multidetector raw CT

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute (\< 1 week) ischemic stroke patient aged 18 to 90
  • Informed consent obtained
  • Presence of health insurance

You may not qualify if:

  • Pregnancy or absence of efficient contraceptive method
  • Allergy
  • Allergy to contrast material
  • Asthma
  • Renal failure (blood creatinine \> 130 µmoles/l, creatinine clearance \< 80 ml/mn according to Cockroft method)
  • Myeloma
  • Hyperthyroidism (uncontrolled)
  • Difficulties to synchronize CT to heart rhythm
  • Contra-indication to TEE or MRI
  • Absence or retirement of informed consent
  • Absence of health insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cardiologique Louis Pradel

Bron, 69677, France

Location

Related Publications (1)

  • Boussel L, Cakmak S, Wintermark M, Nighoghossian N, Loffroy R, Coulon P, Derex L, Cho TH, Douek PC. Ischemic stroke: etiologic work-up with multidetector CT of heart and extra- and intracranial arteries. Radiology. 2011 Jan;258(1):206-12. doi: 10.1148/radiol.10100804. Epub 2010 Nov 9.

MeSH Terms

Conditions

Ischemic StrokeStrokeIschemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • DOUEK Philippe, MD

    Hospices Civils de Lyon

    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

June 30, 2008

First Posted

July 2, 2008

Study Start

March 1, 2008

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 28, 2019

Record last verified: 2013-07

Locations