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

• Sponsor: Rambam Health Care Campus (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01239446
• Collaborator: (none)
• Enrollment: 100
• Location: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma Treated With Mediastinal Irradiation	Other: Not relevant (there is no intervention in the present study)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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.
• Study Start Date: Jan 1, 2011
• Anticipated Primary Completion Date: Jan 1, 2012

Outcome Measures

Primary Outcome Measures

1. Extent of coronary artery plaques and number of perfusion defects in patients enrolled. [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Rambam Healthcare Campus	Haifa		Israel

Sponsors and Collaborators

• Rambam Health Care Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01239446
• Other Study ID Numbers: 0390-10-RMB_BRODOV
• First Posted: Nov 11, 2010
• Last Update Posted: Nov 11, 2010
• Last Verified: Nov 1, 2010

• Keywords provided by , ,: Hodgkin lymphoma; mediastinal irradiation; Coronary Artery Disease
• Additional relevant MeSH terms: Lymphoma; Hodgkin Disease

Study Results

No Results Posted as of Nov 11, 2010