AtherosclerosisCoANCT03999073
Carotid Atherosclerosis in Patients With Aortic Coarctation
An observational study of Atherosclerosis and Aortic Coarctation, run by Skane University Hospital.
Trial summary
Despite aortic coarctation (CoA) repair these patients have cardiovascular complications and coronary artery disease is the most common cause of death. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Aortic Coarctation
- What is being tested?
- Ultrasound measurement
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with aortic coarctation
Who may be able to join
- sex and age-matched controls
Who cannot join
- acute and chronic inflammation disease, underlying malignancies and diabetes mellitus.
About this study
Despite aortic coarctation (CoA) repair these patients have cardiovascular complications and coronary artery disease is the most common cause of death.
Read the detailed description
The aim with this study was to measure intima-media thickness (IMT) and plaques in arteries compared to cardiovascular markers in controls and patients with CoA.
- Conditions
- Atherosclerosis, Aortic Coarctation
- Being tested
- Ultrasound measurement
- Medical subject headings
- Atherosclerosis, Aortic Coarctation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound measurementOther
Ultrasound measurement
| Study group | Role | What they receive |
|---|---|---|
| Subjects with coarctation | Not described Receives: Other: Ultrasound measurement | |
| Controls | Not described Receives: Other: Ultrasound measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intima-media thickness
Measurement in mm
Measured: Intima-media thickness will be measured at one time point namely at inclusion. Data will be reported when study is completed, an average of 2 year.
Secondary outcomes (1)
Cardiovascular markers
A multiplex platform to analyze circulating blood levels biomarkers was used.
Measured: Blood samples will be taken at one time point namely at inclusion. Then biomarkers will be analysed when study is completed. Data will be reported when study is completed, an average of 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study startJan 2012
- Primary completion1 Jan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Hlebowicz, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999073
- Sponsor's protocol ID
- 2017/260
- Acronym
- CoA
- Status last verified
- Jun 2019
- First submitted
- 21 Jun 2019
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hlebowicz J, Holm J, Lindstedt S, Goncalves I, Nilsson J. Carotid atherosclerosis, changes in tissue remodeling and repair in patients with aortic coarctation. Atherosclerosis. 2021 Oct;335:47-52. doi: 10.1016/j.atherosclerosis.2021.09.016. Epub 2021 Sep 21.
PubMed 34564048
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Atherosclerosis in Patients With Aortic Coarctation
- ClinicalTrials.gov ID
- NCT03999073
- Acronym / sponsor ID
- CoA / 2017/260
- Conditions
- Atherosclerosis, Aortic Coarctation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 26 Jun 2019 (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.
Despite aortic coarctation (CoA) repair these patients have cardiovascular complications and coronary artery disease is the most common cause of death.
Detailed description
The aim with this study was to measure intima-media thickness (IMT) and plaques in arteries compared to cardiovascular markers in controls and patients with CoA.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with coarctation | – | Other: Ultrasound measurement |
| Controls | – | Other: Ultrasound measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with aortic coarctation
Key inclusion criteria (1 listed)
- sex and age-matched controls
Key exclusion criteria (1 listed)
- acute and chronic inflammation disease, underlying malignancies and diabetes mellitus.
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 |
|---|---|---|
| Ultrasound measurementUltrasound measurement | Other | Controls, Subjects with coarctation |
Primary outcome
Intima-media thickness
Time frame: Intima-media thickness will be measured at one time point namely at inclusion. Data will be reported when study is completed, an average of 2 year.
Measurement in mm
1 secondary outcome
Cardiovascular markers
Time frame: Blood samples will be taken at one time point namely at inclusion. Then biomarkers will be analysed when study is completed. Data will be reported when study is completed, an average of 2 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Derived from this study: PubMed 34564048Hlebowicz J, Holm J, Lindstedt S, Goncalves I, Nilsson J. Carotid atherosclerosis, changes in tissue remodeling and repair in patients with aortic coarctation. Atherosclerosis. 2021 Oct;335:47-52. doi: 10.1016/j.atherosclerosis.2021.09.016. Epub 2021 Sep 21.
- 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 Atherosclerosis and Aortic Coarctation, run by Skane 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: finished, as of the sponsor's last update on 26 Jun 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intima-media thickness (time frame: Intima-media thickness will be measured at one time point namely at inclusion. Data will be reported when study is completed, an average of 2 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03999073, which also lists 1 linked publication.
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 26 Jun 2019; AzTrials last refreshed its copy on 6 Nov 2026.