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

NCT ID: NCT02985931

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-05-31

Brief Summary

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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

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Conditions

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Quantitative Analysis of SPECT MPI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Suspected CAD subjects

Diagnostic imaging scans of SPECT and MRI

Intervention Type OTHER

Interventions

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Diagnostic imaging scans of SPECT and MRI

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Subjects with high possibility of coronary artery disease after being evaluated by a cardiologist.
2. \> 20 years old.
3. Not under infection or other conditions inappropriate for being recruited.
4. Without myocardial infarction within one week.
5. With stable blood pressure.
6. Subjects with normal kidney functions and without allergic reactions to MRI contrast agents.

Exclusion Criteria

1. Subjects who cannot take a SPECT scan or do not agree to sign the informed consent.
2. Pregnant subjects or subjects who are currently breast-feeding.
3. Those currently under radiation therapies.
4. Patients with pleural effusion.
5. Patients who are allergic to SPECT tracers.
6. Patients with serious psychological disorders.
7. Patients with asthma.
8. Patients with stroke within a week.
9. Patients with AV block.
10. Patients with sinus syndrome.
11. Subjects who are currently under other clinical trials.
12. Subjects with poor kidney functions who are inappropriate for MRI contrast agents.
13. Subjects with pacemakers.
14. Subjects with Claustrophobia.
15. Subjects who cannot hold breath for cardiac MRI studies.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tzu-Chen Yen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tzu-Chen Yen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Other Identifiers

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101-0453A3

Identifier Type: -

Identifier Source: org_study_id