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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03999073
Other study ID # 2017/260
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2012
Est. completion date January 2019

Study information

Verified date June 2019
Source Skane University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Despite aortic coarctation (CoA) repair these patients have cardiovascular complications and coronary artery disease is the most common cause of death.


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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date January 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- sex and age-matched controls

Exclusion Criteria:

- acute and chronic inflammation disease, underlying malignancies and diabetes mellitus.

Study Design


Intervention

Other:
Ultrasound measurement
Ultrasound measurement

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Skane University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Intima-media thickness Measurement in mm 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 Cardiovascular markers A multiplex platform to analyze circulating blood levels biomarkers was used. 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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