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123I-MIBG SPECT/CT for Assessment of Cardiac Sympathetic Innervation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00296738
First Posted: February 27, 2006
Last Update Posted: August 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rambam Health Care Campus
  Purpose
Myocardial scintigraphy with 123I-MIBG allows for visual and semi-quantitative assessment of sympathetic cardiac innervation using the hear to mediastinum ratio (HMR). Impaired cardiac MIBG clearance may occur in patients with congestive heart failure (CHF). The purpose of present study was to develop and validate a quantitative index for the assessment of cardiac MIBG uptake kinetics using SPECT/CT for diagnosis of CHF

Condition Intervention Phase
Cardiac Diseases Device: SPECT/CT Early Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quantitative 123I-MIBG SPECT/CT Assessment of Cardiac Sympathetic Innervation

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • The impact of the imaging modality on patient management [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • The impact on patient management [ Time Frame: 2 years ]

Enrollment: 50
Study Start Date: May 2007
Study Completion Date: May 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: SPECT/CT
    GE INFINIA HAWKEYE
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients refered for neuroendocrine diseases
Criteria

Inclusion Criteria:

  • age>40

Exclusion Criteria:

  Contacts and Locations
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): NCT00296738


Locations
Israel
Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Shmuel Rispler, MD PhD Rambam Health Care Campus
  More Information

Responsible Party: Dr. Alex Frenkel, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT00296738     History of Changes
Other Study ID Numbers: MIBGCTIL
First Submitted: February 24, 2006
First Posted: February 27, 2006
Last Update Posted: August 18, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases