Hybrid SPECT/CTCA for the Assessment of the Presence and Hemodynamic Significance of CAD in Asymptomatic Patients.
|ClinicalTrials.gov Identifier: NCT01239446|
Recruitment Status : Unknown
Verified November 2010 by Rambam Health Care Campus.
Recruitment status was: Not yet recruiting
First Posted : November 11, 2010
Last Update Posted : November 11, 2010
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 or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma Treated With Mediastinal Irradiation||Other: Not relevant (there is no intervention in the present study)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2011|
|Estimated Primary Completion Date :||January 2012|
Other: Not relevant (there is no intervention in the present study)
- Extent of coronary artery plaques and number of perfusion defects in patients enrolled. [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239446
|Contact: Yafim Brodov, MDfirstname.lastname@example.org|
|Rambam Healthcare Campus||Not yet recruiting|
|Sub-Investigator: Yafim Brodov, MD|