123I-MIBG SPECT/CT for Assessment of Cardiac Sympathetic... | NCT00296738

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

NCT00296738

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Aug 18, 2011Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Cardiac Diseases

Interventions

SPECT/CT

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Aug 2009Actual

Completion Date

May 2010Actual

First Submitted Date

Feb 24, 2006

First Submission Date that Met QC Criteria

Feb 24, 2006

First Posted Date

Feb 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2011

Last Update Posted Date

Aug 18, 2011Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Name	Type	Description	Arm Group Labels	Other Names
SPECT/CT	Device	GE INFINIA HAWKEYE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The impact of the imaging modality on patient management		2 years

Secondary Outcomes

Measure	Description	Time Frame
The impact on patient management		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age>40

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients refered for neuroendocrine diseases

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shmuel Rispler, MD PhD	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Medical Center		Haifa			Israel

ID	Term
D006331	Heart Diseases

ID	Term
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000072098	Single Photon Emission Computed Tomography Computed Tomography

Ancestor Terms

ID	Term
D015899	Tomography, Emission-Computed, Single-Photon
D014055	Tomography, Emission-Computed
D007090	Image Interpretation, Computer-Assisted
D003952	Diagnostic Imaging

Browse Leaves

Not provided

Browse Branches

Not provided