Know Cancer

or
forgot password

Assessment of Endothelial Function and IMT in Survivors Hodgkin's Lymphoma Patients


N/A
18 Years
50 Years
Open (Enrolling by invite only)
Both
Hodgkin's Lymphoma

Thank you

Trial Information

Assessment of Endothelial Function and IMT in Survivors Hodgkin's Lymphoma Patients


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.


Inclusion Criteria:



- Hodgkin's disease survivors over 18 years old

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Frequencey of endothelial dysfunction by FMD

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Dalit Modan, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sheba Medical Center

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

SHEBA-06-4359-DM-CTIL

NCT ID:

NCT00428688

Start Date:

July 2009

Completion Date:

August 2014

Related Keywords:

  • Hodgkin's Lymphoma
  • Hodgkin's lymphoma
  • cardiovascular disease
  • radiation therapy
  • Brachial artery flow-mediated dilation (FMD)
  • Hodgkin Disease
  • Lymphoma

Name

Location