Single-scan Rest/Stress Imaging With Cadmium Zinc Telluri... | NCT02985931

Studies
Single-scan Rest/Stress Imaging With Cadmium Zinc Telluride-based SPECT for Coronary Flow Quantification

NCT02985931

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Dec 7, 2016Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Quantitative Analysis of SPECT MPI

Interventions

Diagnostic imaging scans of SPECT and MRI

Countries

Not provided

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 2016

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 2012

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Dec 1, 2016

First Submission Date that Met QC Criteria

Dec 4, 2016

First Posted Date

Dec 7, 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 4, 2016

Last Update Posted Date

Dec 7, 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

The investigators aim to address this issue with novel image quantification methods using CZT-based SPECT, which is capable of dynamic data acquisition and therefore feasible for the quantification of the coronary flow. The investigators will use kinetic modeling techniques to design a study that allows the absolute flow quantification. To make this study practical, the investigators will develop a protocol that includes the acquisition of both the rest and stress scan within the same scan that is shorter than 30 minutes. The SPECT-measured flow will be validated against the flow measured with cardiac MRI scans. Patients with high CAD risk will be recruited for the clinical trial. Data from these human subjects will be used for determination of the performance of the developed algorithm. With the proposed rapid scan with absolute quantification capabilities, the investigators expect to increase the diagnosis accuracy while maintaining the patient throughput.

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

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

30Actual

Label	Type	Description	Intervention Names
Suspected CAD subjects			Other: Diagnostic imaging scans of SPECT and MRI

Name	Type	Description	Arm Group Labels	Other Names
Diagnostic imaging scans of SPECT and MRI	Other		Suspected CAD subjects

Measure	Description	Time Frame
Correlation between SPECT- and MRI-measured flow values		through study completion, an average of 3 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with high possibility of coronary artery disease after being evaluated by a cardiologist.
> 20 years old.
Not under infection or other conditions inappropriate for being recruited.
Without myocardial infarction within one week.
With stable blood pressure.
Subjects with normal kidney functions and without allergic reactions to MRI contrast agents.

Exclusion Criteria:

Subjects who cannot take a SPECT scan or do not agree to sign the informed consent.
Pregnant subjects or subjects who are currently breast-feeding.
Those currently under radiation therapies.
Patients with pleural effusion.
Patients who are allergic to SPECT tracers.
Patients with serious psychological disorders.
Patients with asthma.
Patients with stroke within a week.
Patients with AV block.
Patients with sinus syndrome.
Subjects who are currently under other clinical trials.
Subjects with poor kidney functions who are inappropriate for MRI contrast agents.
Subjects with pacemakers.
Subjects with Claustrophobia.
Subjects who cannot hold breath for cardiac MRI studies.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects who are suspected with coronary artery diseases and need imaging exams.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Tzu-Chen Yen, MD, PhD	Chang Gung Memorial Hospital	Principal Investigator

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

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Browse Branches

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