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

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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
Information provided by:
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.

Condition or disease Intervention/treatment
Hodgkin Lymphoma Treated With Mediastinal Irradiation Other: Not relevant (there is no intervention in the present study)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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 : January 2011
Estimated Primary Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Other: Not relevant (there is no intervention in the present study)
    Not relevant (there is no intervention in the present study)

Primary Outcome Measures :
  1. Extent of coronary artery plaques and number of perfusion defects in patients enrolled. [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239446

Contact: Yafim Brodov, MD +972502061452 y_brodov@rambam.health.gov.il

Rambam Healthcare Campus Not yet recruiting
Haifa, Israel
Sub-Investigator: Yafim Brodov, MD         
Sponsors and Collaborators
Rambam Health Care Campus

Responsible Party: Yafim Brodov, MD, Rambam HEalthcare Campus
ClinicalTrials.gov Identifier: NCT01239446     History of Changes
Other Study ID Numbers: 0390-10-RMB_BRODOV
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: November 11, 2010
Last Verified: November 2010

Keywords provided by Rambam Health Care Campus:
Hodgkin lymphoma
mediastinal irradiation
Coronary Artery Disease

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases