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
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
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
NCT ID
NCT01239446
First Posted
November 10, 2010
Last Updated
November 10, 2010
Sponsor
Rambam Health Care Campus
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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