ClinicalTrials.gg
CompletedNCT03999073CoAUpdated Jun 26, 2019

Carotid Atherosclerosis in Patients With Aortic Coarctation

An observational study in Atherosclerosis and Aortic Coarctation, sponsored by Skane University Hospital. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-26.

Sponsored by Skane University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
116
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Atherosclerosis
  • Aortic Coarctation
03

In context

Atherosclerosis

1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.

This study's enrollment of 116 is below the median of 250 across 527 observational studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Skane University Hospital is the lead sponsor of 73 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with aortic coarctation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • sex and age-matched controls

Exclusion criteria

Exclusion Criteria:

  • acute and chronic inflammation disease, underlying and diabetes mellitus.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
116 participants (actual)
Patient registry
No

Groups and cohorts

  • Subjects with coarctation

    Other: Ultrasound measurement

  • Controls

    Other: Ultrasound measurement

Interventions

  • OtherUltrasound measurement

    Ultrasound measurement

06

What researchers measure

Primary outcomes

  1. Intima-media thickness

    Measurement in mm

    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.

Secondary outcomes

  1. Cardiovascular markers

    A multiplex platform to analyze circulating blood levels biomarkers was used.

    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.

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Study locations

No study locations are listed for this record.

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References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2012 to primary completion in Jan 2019, 84 months.

Of 144 non-industry observational studies under Atherosclerosis, half reached primary completion within 84 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 158. This study's 84 months is close to that.

Counting every sponsor, half of 169 studies reached it within 62 months; a quarter within 31 and three quarters within 153.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2019
First posted
Jun 26, 2019
StartActual
Jan 2012
Primary completionActual
Jan 1, 2019
CompletionActual
Jan 2019
Last update
Jun 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03999073
Lead sponsor
Skane University Hospital
Responsible party
Joanna Hlebowicz (MD, Associated Professor, Skane University Hospital) — Principal investigator
First posted
Jun 26, 2019
Start date
Jan 2012
Primary completion
Jan 1, 2019
Completion
Jan 2019
Last update
Jun 26, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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