Marfan Syndrome Clinical Trial
Official title:
Development of a Blood Test for Marfan Syndrome
The objective of this study is to determine whether a simple blood test can be a useful clinical tool for monitoring aortic disease in Marfan syndrome and Marfan-related disorders.
Status | Recruiting |
Enrollment | 336 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 4 Years to 26 Years |
Eligibility |
Inclusion Criteria: - Age 4-26 years of age for all participants - Diagnosis of Marfan syndrome, Loeys-Dietz syndrome, vascular Ehlers-Danlos syndrome, or Familial Thoracic Aortic Aneurysm and Dissection for inclusion in Marfan and Marfan-related disorders groups - Diagnosis of unaffected by Marfan syndrome and Marfan-related disorders for inclusion in control group - Able and willing to sign informed consent/assent - Signed HIPPA compliant research authorization Exclusion Criteria: - Other known cardiovascular disorder for unaffected controls |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Lurie Childrens Hospital | Chicago | Illinois |
United States | University of Texas at Houston | Houston | Texas |
United States | University of Nebraska | Omaha | Nebraska |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Shriners Hospital for Children | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Shriners Hospitals for Children | Oregon Health and Science University, The University of Texas Health Science Center, Houston, University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | medical and lifestyle issues | Information from questionnaires will be associated with aortic root growth and concentrations of circulating microfibril fragments. | yearly for five years | No |
Primary | microfibril fragments | Plasma will be tested using sandwich ELISAs and standard curves to quantitate fragments of fibrillin-1, fibrillin-2, and fibulin-4. | measured yearly over 5 years | No |
Secondary | Aortic root growth | Aortic root growth will be correlated with concentrations of circulating microfibril fragments. | yearly for five years | No |
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