CoA: Carotid Atherosclerosis in Patients With Aortic Coarctation
Sponsor
Skane University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03999073
Collaborator
(none)
116
84
Study Details
Study Description
Brief Summary
Despite aortic coarctation (CoA) repair these patients have cardiovascular complications and coronary artery disease is the most common cause of death.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Study Type:
Observational
Actual Enrollment
:
116 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
Carotid Atherosclerosis in Patients With Aortic Coarctation
Actual Study Start Date
:
Jan 1, 2012
Actual Primary Completion Date
:
Jan 1, 2019
Actual Study Completion Date
:
Jan 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Subjects with coarctation
|
Other: Ultrasound measurement
Ultrasound measurement
|
| Controls
|
Other: Ultrasound measurement
Ultrasound measurement
|
Outcome Measures
Primary Outcome Measures
- Intima-media thickness [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
Secondary Outcome Measures
- Cardiovascular markers [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.]
A multiplex platform to analyze circulating blood levels biomarkers was used.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- sex and age-matched controls
Exclusion Criteria:
- acute and chronic inflammation disease, underlying malignancies and diabetes mellitus.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Skane University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Joanna Hlebowicz,
MD, Associated Professor,
Skane University Hospital
ClinicalTrials.gov Identifier:
NCT03999073
Other Study ID Numbers:
- 2017/260
First Posted:
Jun 26, 2019
Last Update Posted:
Jun 26, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: