Endothelial Function and IMT in Survivors of Hodgkin's Lymphoma

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Dr. Dalit Modan, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00428688
First received: January 28, 2007
Last updated: December 12, 2012
Last verified: December 2012

January 28, 2007
December 12, 2012
July 2009
August 2014   (final data collection date for primary outcome measure)
Frequencey of endothelial dysfunction by FMD [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00428688 on ClinicalTrials.gov Archive Site
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Endothelial Function and IMT in Survivors of Hodgkin's Lymphoma
Assessment of Endothelial Function and IMT in Survivors Hodgkin's Lymphoma Patients

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Young-adult survivors of Hodgkin's disease

Hodgkin's Lymphoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
40
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hodgkin's disease survivors over 18 years old
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00428688
SHEBA-06-4359-DM-CTIL
No
Dr. Dalit Modan, Sheba Medical Center
Sheba Medical Center
Not Provided
Principal Investigator: Dalit Modan, M.D Sheba Medical Center
Principal Investigator: Michael Schechter, M.D Sheba Medical Center
Sheba Medical Center
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP