NCT00590421

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
295

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2007

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 10, 2008

Completed
Last Updated

October 17, 2008

Status Verified

December 1, 2007

Enrollment Period

2.5 years

First QC Date

December 31, 2007

Last Update Submit

October 16, 2008

Conditions

Atherosclerosis

Study Arms (2)

1

145 individuals treated by irradiation in their childhood

2

150 matched control subjects with no history of irradiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study was designed to include 150 persons who were treated as children for Tinea Capitis by scalp irradiation in the 1950's and 150 subjects who were not exposed to radiation. This sample size was determined under the following assumption: power of ≥95%, alpha error level of 5%, 10% prevalence of carotid stenosis in the non exposed group and minimal OR of 2.5.

You may qualify if:

  • age 18 or older
  • childhood scalp irradiation or mach controls
  • writen informed consent

You may not qualify if:

  • inability to give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples, 10 ml, were procured for assessment of creatinine, total cholesterol, high density lipoproteins (HDL), triglycerides (TG), calculated low density lipoproteins (LDL) and homocysteine.

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Shai Efrati, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 31, 2007

First Posted

January 10, 2008

Study Start

July 1, 2004

Primary Completion

January 1, 2007

Study Completion

November 1, 2007

Last Updated

October 17, 2008

Record last verified: 2007-12

Locations

IL(1)