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

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.

Study Overview

• Status: Completed
• Conditions: Quantitative Analysis of SPECT MPI
• Intervention / Treatment: Other: Diagnostic imaging scans of SPECT and MRI

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected CAD subjects	Other: Diagnostic imaging scans of SPECT and MRI

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Tzu-Chen Yen, MD, PhD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: December 4, 2016
• First Posted (Estimate): December 7, 2016

Study Record Updates

• Last Update Posted (Estimate): December 7, 2016
• Last Update Submitted That Met QC Criteria: December 4, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 101-0453A3