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Hybrid SPECT/CTCA for the Assessment of the Presence and Hemodynamic Significance of CAD in Asymptomatic Patients.

Primary Purpose

Hodgkin Lymphoma Treated With Mediastinal Irradiation

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Not relevant (there is no intervention in the present study)
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hodgkin Lymphoma Treated With Mediastinal Irradiation focused on measuring Hodgkin lymphoma, mediastinal irradiation, Coronary Artery Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Asymptomatic HL patients without evidence of disease and without prior history of CAD that underwent mediastinal irradiation due to HL

Exclusion Criteria:

  • Known CAD (these patients will be excluded from the imaging study, but will be analyzed as separate control group)
  • active HL or other active malignancy
  • chronic renal failure
  • pregnant/ nursing women
  • previous allergic reaction to iodine contrast media

Sites / Locations

  • Rambam Healthcare Campus

Outcomes

Primary Outcome Measures

Extent of coronary artery plaques and number of perfusion defects in patients enrolled.

Secondary Outcome Measures

Full Information

First Posted
November 10, 2010
Last Updated
November 10, 2010
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT01239446
Brief Title
Hybrid SPECT/CTCA for the Assessment of the Presence and Hemodynamic Significance of CAD in Asymptomatic Patients.
Official Title
Hybrid Single-Photon Emission Computed Tomography/Computed Tomography Coronary Angiography for the Assessment of the Presence and Hemodynamic Significance of CAD in Asymptomatic Patients After Mediastinal Irradiation for Hodgkin Lymphoma.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Mediastinal irradiation for treatment of malignancy increases the risk for coronary artery disease (CAD), while diabetes mellitus or other known risk factors can be absent at the time of the first coronary event. Radiation-induced atherosclerosis affects the coronary ostia and proximal coronary segments, or causes diffuse microvascular damage. Younger patients and those exposed to high radiation doses (> 35 Gy) have a higher risk for developing premature CAD and likely may benefit from coronary assessment. A novel hybrid imaging technique that combines SPECT and CTCA has been shown to overcome the individual pitfalls and the diagnostic challenges of stand-alone SPECT and CCTA, improve the lesion detectability and sensitivity in patients with balanced diffuse lesions as well as the specificity and mainly PPV of CTCA. The aim of the study is to perform hybrid SPECT/CTCA in asymptomatic patients with HL who have received radiotherapy to the mediastinum in order to allow an early diagnosis of hemodynamically significant CAD that will need further therapeutic interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma Treated With Mediastinal Irradiation
Keywords
Hodgkin lymphoma, mediastinal irradiation, Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Not relevant (there is no intervention in the present study)
Intervention Description
Not relevant (there is no intervention in the present study)
Primary Outcome Measure Information:
Title
Extent of coronary artery plaques and number of perfusion defects in patients enrolled.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Asymptomatic HL patients without evidence of disease and without prior history of CAD that underwent mediastinal irradiation due to HL Exclusion Criteria: Known CAD (these patients will be excluded from the imaging study, but will be analyzed as separate control group) active HL or other active malignancy chronic renal failure pregnant/ nursing women previous allergic reaction to iodine contrast media
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yafim Brodov, MD
Phone
+972502061452
Email
y_brodov@rambam.health.gov.il
Facility Information:
Facility Name
Rambam Healthcare Campus
City
Haifa
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yafim Brodov, MD

12. IPD Sharing Statement

Learn more about this trial

Hybrid SPECT/CTCA for the Assessment of the Presence and Hemodynamic Significance of CAD in Asymptomatic Patients.

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