NCT03999073

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

7 years

First QC Date

June 21, 2019

Last Update Submit

June 24, 2019

Conditions

AtherosclerosisAortic Coarctation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (2)

Subjects with coarctation

Other: Ultrasound measurement

Controls

Other: Ultrasound measurement

Interventions

Ultrasound measurementOTHER

Ultrasound measurement

ControlsSubjects with coarctation

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailssex and age-matched controls
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with aortic coarctation

You may qualify if:

  • sex and age-matched controls

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34564048DERIVED

MeSH Terms

Conditions

AtherosclerosisAortic Coarctation

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associated Professor

Study Record Dates

First Submitted

June 21, 2019

First Posted

June 26, 2019

Study Start

January 1, 2012

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

June 26, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share