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

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00296738
First received: February 24, 2006
Last updated: August 17, 2011
Last verified: August 2011
History of Changes
  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
 Phase 0

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

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The impact on patient management [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients refered for neuroendocrine diseases

Criteria

Inclusion Criteria:

  • age>40

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Alex Frenkel, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT00296738     History of Changes
Other Study ID Numbers: MIBGCTIL
Study First Received: February 24, 2006
Last Updated: August 17, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013