- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03581162
Atherosclerosis in Juvenile Mixed Connective Tissue Disease (ACTID) (ACTID)
June 26, 2018 updated by: Karolina Ryeng Skagen, Oslo University Hospital
Atherosclerosis in Juvenile Mixed Connective Tissue Disease
This Study investigates presence of preclinical atherosclerosis in patients with Juvenile Mixed Connective Tissue Disease in Norway.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients and controls are examined with carotid ultrasound, venous blood is drawn, and they undergo a clinical examination.
Study Type
Observational
Enrollment (Anticipated)
50
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with diagnosis of Juvenile Mixed Connective TIssue Disease in Norway
Description
Inclusion Criteria:
- Diagnosis of MIxed Connective Tissue Disease
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients
Patients with diagnosis of Juvenile Mixed Connective Tissue Disease
|
Carotid ultrasound and blood sampling
|
|
Controls
Healthy, age-and sex-matched controls
|
Carotid ultrasound and blood sampling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of carotid atherosclerosis
Time Frame: 20 minutes
|
measuring intima-media thickness
|
20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
blood markers of endothelial dysfunction
Time Frame: 20 minutes
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2012
Primary Completion (Actual)
November 1, 2017
Study Completion (Anticipated)
December 1, 2037
Study Registration Dates
First Submitted
June 26, 2018
First Submitted That Met QC Criteria
June 26, 2018
First Posted (Actual)
July 10, 2018
Study Record Updates
Last Update Posted (Actual)
July 10, 2018
Last Update Submitted That Met QC Criteria
June 26, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012/1721
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.