NCT02749916

Brief Summary

This study aims to compare image-based characteristics of carotid walls between symptomatic side and the opposite side. The design of this study is phase IV, prospective observational study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

April 19, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

3.3 years

First QC Date

April 19, 2016

Last Update Submit

September 17, 2019

Conditions

Carotid Plaque Imaging

Keywords

SWIMP-RAGEDANTE T1-SPACE

Outcome Measures

Primary Outcomes (1)

  • Detection rate of findings of vulnerable carotid plaque

    within 3 days after enrollment

Secondary Outcomes (1)

  • Accuracy in delinating geometry of carotid inner lumen and outer wall

    within 3 days after enrollment

Study Arms (1)

Patients with acute or recent (within 3months) stroke

Other: Methods of carotid wall imaging

Interventions

Methods of carotid wall imagingOTHER
Patients with acute or recent (within 3months) stroke

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute or recent (within 3months) stroke or TIA (transient ischaemic attack)

You may qualify if:

  • Patients with acute or recent (within 3months) stroke or TIA
  • % stenosis of internal carotid artery by NASCET criteria
  • Written informed consent, prior to registration

You may not qualify if:

  • Hemorrhagic stroke
  • Previous history of carotid endarterectomy (CEA), angioplasty, or stenting
  • Contraindication for MR imaging
  • Hypersensitivity to gadolinium based contrast media
  • Pregnant or lactating women
  • Patients under age of 19-year-old
  • Renal condition : eGFR \< 60
  • Patients unable and/or unwilling to comply with treatment or study instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asan Medical Center

Seoul, South Korea

Location

Seoul St. Mary's Hospital

Seoul, South Korea

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 25, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

September 18, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)