Comparison of Gated Blood-pool SPECT and Echocardiogram f... | NCT02644850

Studies
Comparison of Gated Blood-pool SPECT and Echocardiogram for Ventricular Function

NCT02644850

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Jan 1, 2016Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Ventricular Dysfunction

Interventions

Not provided

Countries

Taiwan

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

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Dec 29, 2015

First Submission Date that Met QC Criteria

Dec 30, 2015

First Posted Date

Jan 1, 2016Estimated

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

Dec 30, 2015

Last Update Posted Date

Jan 1, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To compare the calculated biventricular ejection fraction from cadmium-zinc-telluride (CZT) single photon emission computed tomography (SPECT) with planar equilibrium radionuclide angiography (ERNA), first-pass radionuclide ventriculography (FP-RNV) and echocardiogram.

Detailed Description

To evaluate the feasibility of using CZT SPECT as an "all-in-one" technique to provide information on both left ventricular ejection fraction (LVEF) and right ventricular ejection fraction (RVEF) derived from a single examination and compare with the values from traditional planar ERNA, FP-RNV and echocardiography.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure the biventricular ejection fraction		Through study completion, an average of 3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients underwent transthoracic echocardiogram and resting cardiac function within interval of 90 days of each other

Exclusion Criteria:

Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients underwent transthoracic echocardiogram and resting cardiac function within interval of 90 days of each other

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mei-Fang Cheng, M.D.	Contact	886-2-23123456	65575	meifang@ntuh.gov.tw

Overall Officials

Name	Affiliation	Role
Mei-Fang Cheng, M.D.	National Taiwan University Hospital and National Taiwan University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital and National Taiwan University College of Medicine	Recruiting	Taipei		100	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018754	Ventricular Dysfunction

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided