NCT04925869

Brief Summary

The objective of this study is to specify the typology of CVA in French Guiana by prospectively comparing consecutive strokes observed at each of the three study sites (Cayenne, Tours, Besançon)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

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

May 7, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

11 months

First QC Date

June 8, 2021

Last Update Submit

June 8, 2021

Conditions

Cerebrovascular AccidentThrombolysis

Outcome Measures

Primary Outcomes (1)

  • Describe the types of CVA and assess their risk factors on clinical, radiological and biological evidence

    Clinical assessment of stroke (NIHSS score) and systematic collection of vascular risk factors (diabetes, hypertension, dyslipidemia, emboligic heart disease) Suspected mechanism (TOAST). Modified Rankin score

    3 months

Secondary Outcomes (1)

  • Compare the time required for treatment between Cayenne, Besançon and Tours in the event of an indication for thrombolysis

    3 months

Study Arms (3)

The hospitals of Besançon

Adult patients with MRI-confirmed CVA admitted to the hospitals of Besançon

Other: Observational study

the hospitals of Cayenne

Adult patients with MRI-confirmed CVA admitted to the hospitals of Cayenne.

Other: Observational study

the hospitals of Tours

Adult patients with MRI-confirmed CVA admitted to the hospitals of Tours.

Other: Observational study

Interventions

Observational studyOTHER

Observational study

The hospitals of Besançonthe hospitals of Cayennethe hospitals of Tours

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with MRI-confirmed CVA admitted to the hospitals of Besançon, Cayenne, and Tours.

You may qualify if:

  • Patient with a diagnosis of Cerebral Vascular Accident confirmed on MRI

You may not qualify if:

  • Age under 18 years
  • Absence of MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Cayenne

Cayenne, Guiana, 97306, French Guiana

Location

MeSH Terms

Conditions

Stroke

Interventions

Observation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Bertrand De Toffol, PHD

    Centre Hospitalier de Cayenne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2021

First Posted

June 14, 2021

Study Start

May 7, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

June 14, 2021

Record last verified: 2021-06

Locations

FR(1)