Clinical trial NCT00428688: Endothelial Function and IMT in Survivors of Hodgkin's Lymphoma
Official title: Assessment of Endothelial Function and IMT in Survivors Hodgkin's Lymphoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin's Lymphoma
Keywords: Hodgkin's lymphoma
cardiovascular disease
radiation therapy
Brachial artery flow-mediated dilation (FMD)
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-01-30
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young-adult survivors of Hodgkin's disease

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.

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.

Eligibility criteria: Inclusion Criteria:

* Hodgkin's disease survivors over 18 years old

Primary outcomes:
measure: Frequencey of endothelial dysfunction by FMD
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: The Endothelaial function lab, The Heart Institute, Sheba Medical Center, Israel
Study officials:
affiliation: Sheba Medical Center
name: Dalit Modan, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Michael Schechter, M.D
role: PRINCIPAL_INVESTIGATOR
References: