Carotid AtherosclerosisACTIDNCT03581162
Atherosclerosis in Juvenile Mixed Connective Tissue Disease (ACTID)
An observational study of Carotid Atherosclerosis, run by Oslo University Hospital.
Trial summary
This Study investigates presence of preclinical atherosclerosis in patients with Juvenile Mixed Connective Tissue Disease in Norway. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Carotid Atherosclerosis
- What is being tested?
- Carotid Ultrasound and venous blood sampling
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with diagnosis of Juvenile Mixed Connective TIssue Disease in Norway
Who may be able to join
- Diagnosis of MIxed Connective Tissue Disease
Who cannot join
- -
About this study
Official title: Atherosclerosis in Juvenile Mixed Connective Tissue Disease
This Study investigates presence of preclinical atherosclerosis in patients with Juvenile Mixed Connective Tissue Disease in Norway.
Read the detailed description
Patients and controls are examined with carotid ultrasound, venous blood is drawn, and they undergo a clinical examination.
- Conditions
- Carotid Atherosclerosis
- Being tested
- Carotid Ultrasound and venous blood sampling
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Ultrasound and venous blood samplingDiagnostic test
Carotid ultrasound and blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with diagnosis of Juvenile Mixed Connective Tissue Disease Receives: Diagnostic Test: Carotid Ultrasound and venous blood sampling | |
| Controls | Healthy, age-and sex-matched controls Receives: Diagnostic Test: Carotid Ultrasound and venous blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of carotid atherosclerosis
measuring intima-media thickness
Measured: 20 minutes
Secondary outcomes (1)
blood markers of endothelial dysfunction
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study startJan 2012
- Primary completionNov 2017
- Study completionDec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karolina Ryeng Skagen, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581162
- Sponsor's protocol ID
- 2012/1721
- Acronym
- ACTID
- Status last verified
- Jun 2018
- First submitted
- 26 Jun 2018
- Last updated
- 10 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atherosclerosis in Juvenile Mixed Connective Tissue Disease
- ClinicalTrials.gov ID
- NCT03581162
- Acronym / sponsor ID
- ACTID / 2012/1721
- Conditions
- Carotid Atherosclerosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2037 (estimated)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Carotid Ultrasound and venous blood samplingPatients with diagnosis of Juvenile Mixed Connective Tissue Disease |
| Controls | – | Diagnostic Test: Carotid Ultrasound and venous blood samplingHealthy, age-and sex-matched controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diagnosis of Juvenile Mixed Connective TIssue Disease in Norway
Key inclusion criteria (1 listed)
- Diagnosis of MIxed Connective Tissue Disease
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid Ultrasound and venous blood samplingCarotid ultrasound and blood sampling | Diagnostic test | Controls, Patients |
Primary outcome
Presence of carotid atherosclerosis
Time frame: 20 minutes
measuring intima-media thickness
1 secondary outcome
blood markers of endothelial dysfunction
Time frame: 20 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Atherosclerosis, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of carotid atherosclerosis (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.