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

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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01239446

Enrollment

100

Registered

2010-11-11

Start date

2011-01-31

Completion date

Unknown

Last updated

2010-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin Lymphoma Treated With Mediastinal Irradiation

Keywords

Hodgkin lymphoma, mediastinal irradiation, Coronary Artery Disease

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.

Interventions

OTHERNot relevant (there is no intervention in the present study)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Israel

Contacts

Primary ContactYafim Brodov, MD

y_brodov@rambam.health.gov.il+972502061452

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026