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出境医 / 临床实验 / Carotid Atherosclerosis in Patients With Aortic Coarctation (CoA)
Carotid Atherosclerosis in Patients With Aortic Coarctation (CoA)
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 |
|---|---|
| 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.
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 : | January 2012 |
| Actual Primary Completion Date : | January 1, 2019 |
| Actual Study Completion Date : | January 2019 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
| Subjects with coarctation |
Other: Ultrasound measurement
Ultrasound measurement
|
| Controls |
Other: Ultrasound measurement
Ultrasound measurement
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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.
Eligibility Criteria
| 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
Criteria
Inclusion Criteria:
- sex and age-matched controls
Exclusion Criteria:
- acute and chronic inflammation disease, underlying malignancies and diabetes mellitus.
Contacts and Locations
No Contacts or Locations Provided
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | June 21, 2019 | ||||||
| First Posted Date | June 26, 2019 | ||||||
| Last Update Posted Date | June 26, 2019 | ||||||
| Actual Study Start Date | January 2012 | ||||||
| Actual Primary Completion Date | January 1, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
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
|
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures |
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.
|
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| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Carotid Atherosclerosis in Patients With Aortic Coarctation | ||||||
| Official Title | Carotid Atherosclerosis in Patients With Aortic Coarctation | ||||||
| Brief Summary | Despite aortic coarctation (CoA) repair these patients have cardiovascular complications and coronary artery disease is the most common cause of death. | ||||||
| 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 Type | Observational | ||||||
| Study Design | Observational Model: Case-Control Time Perspective: Other |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Probability Sample | ||||||
| Study Population | Patients with aortic coarctation | ||||||
| Condition |
|
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| Intervention | Other: Ultrasound measurement
Ultrasound measurement
|
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| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Completed | ||||||
| Actual Enrollment |
116 | ||||||
| Original Actual Enrollment | Same as current | ||||||
| Actual Study Completion Date | January 2019 | ||||||
| Actual Primary Completion Date | January 1, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | Yes | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | Not Provided | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03999073 | ||||||
| Other Study ID Numbers | 2017/260 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Joanna Hlebowicz, Skane University Hospital | ||||||
| Study Sponsor | Skane University Hospital | ||||||
| Collaborators | Not Provided | ||||||
| Investigators | Not Provided | ||||||
| PRS Account | Skane University Hospital | ||||||
| Verification Date | June 2019 | ||||||
