Low Dose One-Day Tc99m Protocol With a High-Efficiency Cardiac Dedicated Gamma Camera For Detection of Coronary Disease

Study Overview
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Brief Summary
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A prospective single clinical trial to validate the use of a low-dose ( 5mSv) Tc-99m protocol with a high-efficiency cardiac dedicated camera (Dynamic Single Photon Emission Computed Tomography; D-SPECT) to detect myocardial perfusion abnormalities during myocardial perfusion imaging.

Detailed Description
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as above

Official Title
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Validation of a Low-Dose One-Day TC99m Protocol With a High-Efficiency Cardiac Dedicated Gamma Camera for Detection of Coronary Artery Disease

Conditions
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Chest Pain

Intervention / Treatment
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* Radiation: low-dose imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is referred to myocardial perfusion D-SPECT for clinical indications. Written informed consent is obtained by a study investigator. Exclusion Criteria: Patient is diagnosed as having uncontrolled congestive cardiac failure or cardiogenic shock. Patient is diagnosed as having uncontrolled hypertension with resting blood pressure > 220 mm Hg systolic or 110 mm Hg diastolic. Patient pregnancy (known or suspected). Lack of written informed consent Prisoner status Minors under the age of 18 as coronary artery disease is generally an adult disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low-dose imaging<br>low dose versus standard dose imaging | Radiation: low-dose imaging<br>* The study is designed to assess the validity of a low dose ( 5mSv) Tc99m one day protocol using D-SPECT standard protocol as the comparators. D-SPECT cardiac scanner the D-SPECT system uses a solid-state detector, made of an alloy of Cadmium, Zinc, and Telluride, eliminating the need for thick crystals and large photomultiplier tubes. As a result, the system is significantly miniaturized, and ergonomically optimized to both user and patient<br>* Other names: low dose imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summed Rest Score (SRS) Using American Heart Association 17 Segment Polar Map Model | SRS is used to quantify presence/severity of SPECT rest myocardial perfusion defects, as assessed by visual analysis using American Heart Association (AHA) 17 segment polar map model; each segment correlates to a myocardial location. Perfusion abnormalities can be determined in relation to myocardial segment/s affected by ischemia and the perfusion defect severity scored using 0 - 4 scale for each segment (0, normal uptake; 1, mildly reduced uptake; 2, moderately reduced uptake; 3, severely reduced uptake; and 4, no uptake). SRS is calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores > 0 indicate increasingly worse outcomes as the score increases. For each patient, SRS will be compared between standard-low-dose (SLD) imaging from a conventional A-SPECT camera and ultra-low-dose (ULD) imaging from a high-efficiency D-SPECT camera, both acquired on the same day. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial perfusion, Low radiation dose, Single photon emission computed tomography