Endothelial Function and IMT in Survivors of Hodgkin's Lymphoma

Sponsor
Sheba Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00428688
Collaborator
(none)
40
1
61
0.7

Study Details

Study Description

Brief Summary

The aim of the proposed study is to assess endothelial function and IMT, as correlates of cardiovascular disease (CVD), in young adult Hodgkin's disease (HD) survivors, and to relate endothelial function to other risk factors including obesity, dyslipidemia, hyperinsulinemia and fasting glucose.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Disease free survival of Hodgkin's disease (HD) patients has improved dramatically over the past few decades. With the dramatic advance in patient's survival, the prevention and treatment of long-term adverse effects of chemotherapy and radiotherapy has become a major focus of interest. HD survivors have excess mortality compared with the age-matched general population, even after excluding disease relapse. A considerable proportion of the excess mortality is due to cardiovascular disease (CVD), principally ischemic heart disease and stroke.

    The proposed study will assess endothelial function in HD survivors, using the non-invasive technique of brachial artery flow-mediated dilation (FMD), by high-resolution ultrasonography. We will also assess IMT. The results of these tests are independent predictors of atherosclerosis disease progression and cardiovascular event rates. This is a prospective study comprising 40 young-adult (aged 18-30 years) . The study will comprise 40 survivors of HD: 20 patients treated with chemotherapy and radiotherapy to the chest and 20 patients treated with chemotherapy alone. The patients will be compared to age and sex-matched patients from the data base of the endothelial function laboratory at the heart institute of the Sheba Medical Center. In addition to brachial artery endothelial function assessment, the patients will also undergo a physical examination including anthropometric measurements (height, weight, waist and hip circumference), and blood pressure. The evaluation will also include blood tests for glucose, lipid profile, CRP, AST, ALT and insulin. A medical history including smoking history and family history of CVD and dyslipidemia will be obtained.

    Patients treated with radiotherapy to the chest will be compared to patients treated with chemotherapy alone and both patients will be compared to healthy controls. The patients will be characterized by age, risk factors for coronary heart disease and endothelial function as assessed by brachial artery FMD. We will establish the rate of endothelial function abnormalities in survivors of HD and its correlation with the other risk factors.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Endothelial Function and IMT in Survivors Hodgkin's Lymphoma Patients
    Study Start Date :
    Jul 1, 2009
    Anticipated Primary Completion Date :
    Aug 1, 2014
    Anticipated Study Completion Date :
    Aug 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Frequencey of endothelial dysfunction by FMD [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Hodgkin's disease survivors over 18 years old

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Endothelaial function lab, The Heart Institute, Sheba Medical Center, Israel Ramat-Gan Israel 52621

    Sponsors and Collaborators

    • Sheba Medical Center

    Investigators

    • Principal Investigator: Dalit Modan, M.D, Sheba Medical Center
    • Principal Investigator: Michael Schechter, M.D, Sheba Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Dalit Modan, Pediatirc Endocrinologist, Sheba Medical Center
    ClinicalTrials.gov Identifier:
    NCT00428688
    Other Study ID Numbers:
    • SHEBA-06-4359-DM-CTIL
    First Posted:
    Jan 30, 2007
    Last Update Posted:
    Dec 13, 2012
    Last Verified:
    Dec 1, 2012
    Keywords provided by Dr. Dalit Modan, Pediatirc Endocrinologist, Sheba Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 13, 2012