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NCT00296738 Clinical Trial

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

Cardiac Diseases Clinical Trial

Official title:
Quantitative 123I-MIBG SPECT/CT Assessment of Cardiac Sympathetic Innervation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00296738
Other study ID # MIBGCTIL
Secondary ID
Status Completed
Phase Phase 0
First received February 24, 2006
Last updated August 17, 2011
Start date May 2007
Est. completion date May 2010

Study information
Verified date August 2011
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date May 2010
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- age>40

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• SPECT/CT
GE INFINIA HAWKEYE

Locations
Country Name City State
Israel Rambam Medical Center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary The impact of the imaging modality on patient management 2 years No
Secondary The impact on patient management 2 years No
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