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Endothelial Function and IMT in Survivors of Hodgkin's Lymphoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Dr. Dalit Modan, Sheba Medical Center.
Recruitment status was:  Enrolling by invitation
Information provided by (Responsible Party):
Dr. Dalit Modan, Sheba Medical Center Identifier:
First received: January 28, 2007
Last updated: December 12, 2012
Last verified: December 2012
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.

Hodgkin's Lymphoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Endothelial Function and IMT in Survivors Hodgkin's Lymphoma Patients

Resource links provided by NLM:

Further study details as provided by Dr. Dalit Modan, Sheba Medical Center:

Primary Outcome Measures:
  • Frequencey of endothelial dysfunction by FMD [ Time Frame: 2 years ]

Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Young-adult survivors of Hodgkin's disease

Inclusion Criteria:

  • Hodgkin's disease survivors over 18 years old
  Contacts and Locations
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Please refer to this study by its identifier: NCT00428688

The Endothelaial function lab, The Heart Institute, Sheba Medical Center, Israel
Ramat-Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Dalit Modan, M.D Sheba Medical Center
Principal Investigator: Michael Schechter, M.D Sheba Medical Center
  More Information

Responsible Party: Dr. Dalit Modan, Pediatirc Endocrinologist, Sheba Medical Center Identifier: NCT00428688     History of Changes
Other Study ID Numbers: SHEBA-06-4359-DM-CTIL
Study First Received: January 28, 2007
Last Updated: December 12, 2012

Keywords provided by Dr. Dalit Modan, Sheba Medical Center:
Hodgkin's lymphoma
cardiovascular disease
radiation therapy
Brachial artery flow-mediated dilation (FMD)

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on September 21, 2017