NCT00296738

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

August 18, 2011

Status Verified

August 1, 2011

Enrollment Period

2.3 years

First QC Date

February 24, 2006

Last Update Submit

August 17, 2011

Conditions

Cardiac Diseases

Outcome Measures

Primary Outcomes (1)

  • The impact of the imaging modality on patient management

    2 years

Secondary Outcomes (1)

  • The impact on patient management

    2 years

Interventions

SPECT/CTDEVICE

GE INFINIA HAWKEYE

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients refered for neuroendocrine diseases

You may qualify if:

  • age\>40

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Single Photon Emission Computed Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed, Single-PhotonTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Shmuel Rispler, MD PhD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2006

First Posted

February 27, 2006

Study Start

May 1, 2007

Primary Completion

August 1, 2009

Study Completion

May 1, 2010

Last Updated

August 18, 2011

Record last verified: 2011-08

Locations

IL(1)