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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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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

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Conditions

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Hodgkin Lymphoma Treated With Mediastinal Irradiation

Keywords

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Hodgkin lymphoma mediastinal irradiation Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Not relevant (there is no intervention in the present study)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Rambam HEalthcare Campus

Locations

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Rambam Healthcare Campus

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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Yafim Brodov, MD

Role: CONTACT

Phone: +972502061452

Email: [email protected]

Other Identifiers

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0390-10-RMB_BRODOV

Identifier Type: -

Identifier Source: org_study_id