Endothelial Function and IMT in Survivors of Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00428688|
Recruitment Status : Unknown
Verified December 2012 by Dr. Dalit Modan, Sheba Medical Center.
Recruitment status was: Enrolling by invitation
First Posted : January 30, 2007
Last Update Posted : December 13, 2012
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Assessment of Endothelial Function and IMT in Survivors Hodgkin's Lymphoma Patients|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||August 2014|
- Frequencey of endothelial dysfunction by FMD [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428688
|The Endothelaial function lab, The Heart Institute, Sheba Medical Center, Israel|
|Ramat-Gan, Israel, 52621|
|Principal Investigator:||Dalit Modan, M.D||Sheba Medical Center|
|Principal Investigator:||Michael Schechter, M.D||Sheba Medical Center|