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Carotid Atherosclerosis in Patients With Aortic Coarctation (CoA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03999073
Recruitment Status : Completed
First Posted : June 26, 2019
Last Update Posted : June 26, 2019
Information provided by (Responsible Party):
Joanna Hlebowicz, Skane University Hospital

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
Atherosclerosis Aortic Coarctation Other: Ultrasound measurement

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.

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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 : January 2012
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Group/Cohort Intervention/treatment
Subjects with coarctation Other: Ultrasound measurement
Ultrasound measurement

Controls Other: Ultrasound measurement
Ultrasound measurement

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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. ]
    A multiplex platform to analyze circulating blood levels biomarkers was used.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   sex and age-matched controls
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with aortic coarctation

Inclusion Criteria:

  • sex and age-matched controls

Exclusion Criteria:

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

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Responsible Party: Joanna Hlebowicz, MD, Associated Professor, Skane University Hospital Identifier: NCT03999073     History of Changes
Other Study ID Numbers: 2017/260
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carotid Artery Diseases
Aortic Coarctation
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities