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NCT00590421 Clinical Trial

Carotid Atherosclerotic Disease Following Childhood Scalp Irradiation

Atherosclerosis Clinical Trial

Official title:
Carotid Atherosclerotic Disease Following Childhood Scalp Irradiation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00590421
Other study ID # Car&RAD05
Secondary ID 57/04
Status Completed
Phase N/A
First received December 31, 2007
Last updated October 16, 2008
Start date July 2004
Est. completion date November 2007

Study information
Verified date December 2007
Source Assaf-Harofeh Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

Background: During the first half of the 20th century, scalp irradiation was a standard treatment for induction of epilation in children suffering from Tinea Capitis. These children are now more than 50 years old and the aim was to investigate the possible association between their childhood low dose irradiation exposure and development of carotid atherosclerotic disease in adulthood.

Methods: The study included 145 individuals treated by irradiation in their childhood, and 150 matched control subjects with no history of irradiation. B-mode ultrasound imaging and US Doppler were used to measure carotid and femoral stenosis and Intima-Media Thickness (IMT). Blood samples were taken for lipid profile and homocysteine evaluation.

Recruitment information / eligibility
Status Completed
Enrollment 295
Est. completion date November 2007
Est. primary completion date January 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age 18 or older

- childhood scalp irradiation or mach controls

- writen informed consent

Exclusion Criteria:

- inability to give written informed consent

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Assaf Harofeh Medical Center Zerifin

Sponsors (1)
Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

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