NCT04882657

Brief Summary

Prospective multicenter study of consecutive patients with acute ischemic stroke and large intracranial vessel occlusion in which a thorough and systematic evaluation of all variables that may be related to the degree of collateral circulation is performed.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Status
unknown

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

First Submitted

Initial submission to the registry

December 5, 2019

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

1.3 years

First QC Date

December 5, 2019

Last Update Submit

May 11, 2021

Conditions

Keywords

Collateral CirculationIschemic StrokeLarge Vessel Occlusion

Outcome Measures

Primary Outcomes (1)

  • Collateral Circulation grade

    Trough the acute phase of stroke, an average of 24 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with acute ischemic stroke and a large-vessel intracranial occlusion.

You may qualify if:

  • Patients with acute ischemic stroke.
  • Large vessel occlusion of an intracranial internal artery: M1, M2 or TICA. (terminal intracranial carotid artery), as demonstrated by CTA.
  • CTA performed within the first 24 hours after stroke onset. Patients with wake-up stroke are included.
  • A previous modified Rankin Scale score of 0 to 3.
  • The patient or a legal representative signs a written consent to participate.

You may not qualify if:

  • More than 24 hours from last been known to be well.
  • Occlusion of other arterial segments (vertebrobasilar circulation, A1, P1, M3, M4).
  • Age below 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood sampling will be obtained by venipuncture in EDTA tubes at admission and processed at each center. Samples will be sent to the promoter site for genetic and plasma markers analysis.

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Joan Martí-Fàbregas, MD, PhD

CONTACT

Daniel Guisado-Alonso, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 5, 2019

First Posted

May 12, 2021

Study Start

June 1, 2021

Primary Completion

September 30, 2022

Study Completion

December 31, 2022

Last Updated

May 12, 2021

Record last verified: 2021-05