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

Not Applicable

• Conditions: Hodgkin Lymphoma Treated With Mediastinal Irradiation

• Registration Number: NCT01239446
• Lead Sponsor: Rambam Health Care Campus

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-11
• Study First Submitted: 2010-11-10
• Study First Submitted QC: 2010-11-10
• Last Update Submitted: 2010-11-10
• Study First Posted: 2010-11-11
• Last Update Posted: 2010-11-11
• Study Start: 2011-01
• Primary Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Extent of coronary artery plaques and number of perfusion defects in patients enrolled.	12 months

Trial Locations

Locations (1)

Rambam Healthcare Campus; 🇮🇱 Haifa, Israel