Atherosclerosis in Juvenile Mixed Connective Tissue Disea... | NCT03581162

Studies
Atherosclerosis in Juvenile Mixed Connective Tissue Disease (ACTID)

NCT03581162

Sponsor

Oslo University Hospital

Status

Active, not recruiting

Last Update Posted

Jul 10, 2018Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Carotid Atherosclerosis

Interventions

Carotid Ultrasound and venous blood sampling

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012Actual

Primary Completion Date

Nov 2017Actual

Completion Date

Dec 2037Estimated

First Submitted Date

Jun 26, 2018

First Submission Date that Met QC Criteria

Jun 26, 2018

First Posted Date

Jul 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2018

Last Update Posted Date

Jul 10, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Patients and controls are examined with carotid ultrasound, venous blood is drawn, and they undergo a clinical examination.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Carotid Ultrasound and venous blood sampling	Diagnostic Test	Carotid ultrasound and blood sampling	Controls Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of carotid atherosclerosis	measuring intima-media thickness	20 minutes

Secondary Outcomes

Measure	Description	Time Frame
blood markers of endothelial dysfunction		20 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of MIxed Connective Tissue Disease

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with diagnosis of Juvenile Mixed Connective TIssue Disease in Norway

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002340	Carotid Artery Diseases

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000092262	Ultrasonography, Carotid Arteries
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D014463	Ultrasonography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided