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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01239446
First received: November 10, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Extent of coronary artery plaques and number of perfusion defects in patients enrolled. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Not relevant (there is no intervention in the present study)
    Not relevant (there is no intervention in the present study)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239446

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

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

No publications provided

Responsible Party: Yafim Brodov, MD, Rambam HEalthcare Campus
ClinicalTrials.gov Identifier: NCT01239446     History of Changes
Other Study ID Numbers: 0390-10-RMB_BRODOV
Study First Received: November 10, 2010
Last Updated: November 10, 2010
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 22, 2014