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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02148900
Other study ID # 79135
Secondary ID
Status Recruiting
Phase N/A
First received May 23, 2014
Last updated January 4, 2017
Start date May 2013
Est. completion date December 2017

Study information

Verified date January 2017
Source Shriners Hospitals for Children
Contact Lynn Y. Sakai, Ph.D.
Phone 503-221-3436
Email lys@shcc.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

The primary objective of this study is to determine whether increased quantitites of circulating microfibril fragments, measured with a simple blood test, are associated with aortic root size and increased growth of the aortic root in Marfan syndrome and related disorders. The secondary objectives of this study are to: (1) Determine a Marfan "signature" profile of circulating microfibril fragments. (2) Determine if high concentrations of fibrillin-1 fragments are associated with large aortic root diameters. (3) Determine which fibrillin-1 fragments are good biomarkers for aortic root growth and size in Marfan syndrome. (4) Determine the relation between fibrillin-1, aortic root diameter, and medical and lifestyle factors reported on questionnaires.


Recruitment information / eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

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

Sponsors (4)

Lead Sponsor Collaborator
Shriners Hospitals for Children Oregon Health and Science University, The University of Texas Health Science Center, Houston, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

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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