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NCT02692846 · ClinicalTrials.gov registry record
WS-SAVE Study (Williams Syndrome Skin and Vessel Elasticity Study)
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 43
- Enrollment target
NCT02692846: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT02692846 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 43 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02692846 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 43 participants
- Enrollment target
Study Summary
Background: Williams Syndrome (WS) is a genetic disorder. People with WS have less of a protein that allows parts of the body to stretch than other individuals. Researchers are interested in the stretchiness of the skin of people with WS and how it may relate to cardiovascular problems some people with WS develop. They are also interested in identifying exposures such as medications that may change the elasticity of the skin and vessels. Objective: To learn more about the skin and blood vessels in individuals with WS and how those tissues change over time. Eligibility: People ages 5-70 with WS. People ages 1-70 with a medical condition that affects connective tissue. Design: Participants will be screened with a review of their medical records. Participants will have 1 visit. Participants with WS may do so at a Williams Syndrome Association family meeting or camp, or at NIH. Other participants will be seen at NIH. During the visit, participants will have height, weight, and blood pressure measured. Researchers will listen to the participant s chest and abdomen. Participants skin will be examined. It may be photographed. Participants will have photos of their eyes and face taken. Researchers will use a DermaLab Suction Cup Probe. A small suction cup will be placed on the arm with a sticker. It will pull lightly on the skin. This allows a computer to measure skin flexibility. Researchers will use a SphygmoCor. A probe that looks like a dull pencil will be placed on the wrist, neck, and groin area. A computer will measure how fast the pulse is moving and will estimate blood vessel flexibility. Participants may be invited to have these procedures repeated at a later date (2 years from now or more).
Primary Outcome
1\) clinical and objective assessment of the vasculature and skin in individuals with WS, focusing on its elasticity; 2) analysis as to whether skin and vascular elasticity correlate with each other. 3) identification of genetic risk factors contributing to their variability, and 4) non-invasive measurement of urine biomarkers for oxidative stress. Note: with the NHLBI initial submission, items # 3 and 4 above will no longer be evaluated.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2017-03-03 |
| Est. Completion | 2017-12-15 |
What the finished NCT02692846 record still lists
NCT02692846 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 43 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02692846 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02692846 about?
NCT02692846 is a clinical study titled "WS-SAVE Study (Williams Syndrome Skin and Vessel Elasticity Study)". Background: Williams Syndrome (WS) is a genetic disorder. People with WS have less of a protein that allows parts of the body to stretch than other individuals. Researchers are interested in the stretchiness of the skin of people with WS and how it may relate to cardiovascular problems some people ...
What is the current status of trial NCT02692846?
This trial is currently completed. The enrollment target is 43 participants. The study started on 2017-03-03. Estimated completion is 2017-12-15.
Who is sponsoring clinical trial NCT02692846?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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