NCT03581162

Brief Summary

This Study investigates presence of preclinical atherosclerosis in patients with Juvenile Mixed Connective Tissue Disease in Norway.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
138mo left

Started Jan 2012

Longer than P75 for all trials

Status
active not recruiting

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 Progress56%
Jan 2012Dec 2037

Study Start

First participant enrolled

January 1, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
19.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2037

Expected
Last Updated

July 10, 2018

Status Verified

June 1, 2018

Enrollment Period

5.8 years

First QC Date

June 26, 2018

Last Update Submit

June 26, 2018

Conditions

Carotid Atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Presence of carotid atherosclerosis

    measuring intima-media thickness

    20 minutes

Secondary Outcomes (1)

  • blood markers of endothelial dysfunction

    20 minutes

Study Arms (2)

Patients

Patients with diagnosis of Juvenile Mixed Connective Tissue Disease

Diagnostic Test: Carotid Ultrasound and venous blood sampling

Controls

Healthy, age-and sex-matched controls

Diagnostic Test: Carotid Ultrasound and venous blood sampling

Interventions

Carotid Ultrasound and venous blood samplingDIAGNOSTIC_TEST

Carotid ultrasound and blood sampling

ControlsPatients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with diagnosis of Juvenile Mixed Connective TIssue Disease in Norway

You may qualify if:

  • Diagnosis of MIxed Connective Tissue Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carotid Artery Diseases

Interventions

Ultrasonography, Carotid ArteriesBlood Specimen Collection

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingClinical Laboratory TechniquesPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor/PostDoc

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 10, 2018

Study Start

January 1, 2012

Primary Completion

November 1, 2017

Study Completion (Estimated)

December 1, 2037

Last Updated

July 10, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share