Hybrid SPECT/CTCA for the Assessment of the Presence and Hemodynamic Significance of CAD in Asymptomatic Patients.
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hodgkin Lymphoma Treated With Mediastinal Irradiation |
Other: Not relevant (there is no intervention in the present study) |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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. |
- Extent of coronary artery plaques and number of perfusion defects in patients enrolled. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2011 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
-
Other: Not relevant (there is no intervention in the present study)
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Yafim Brodov, MD | +972502061452 | y_brodov@rambam.health.gov.il |
| Israel | |
| Rambam Healthcare Campus | Not yet recruiting |
| Haifa, Israel | |
| Sub-Investigator: Yafim Brodov, MD | |
More Information
No publications provided
| Responsible Party: | Yafim Brodov, MD, Rambam HEalthcare Campus |
| ClinicalTrials.gov Identifier: | NCT01239446 History of Changes |
| Other Study ID Numbers: | 0390-10-RMB_BRODOV |
| Study First Received: | November 10, 2010 |
| Last Updated: | November 10, 2010 |
| Health Authority: | Israel: Ethics Commission Israel: Ministry of Health |
Keywords provided by Rambam Health Care Campus:
|
Hodgkin lymphoma mediastinal irradiation Coronary Artery Disease |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013