Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging

Study Overview
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Brief Summary
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We propose a single-scan two-injection myocardial perfusion imaging protocol using ammonia. Subjects will undergo single-scan two-injection imaging as well as regular stress single-scan single-injection protocol and the myocardial blood flow of both techniques will be compared.

Official Title
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Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging

Conditions
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Coronary Artery Disease, Myocardial Ischemia

Intervention / Treatment
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* Diagnostic Test: Single-Scan Two-Injection Protocol


Participation Criteria
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Eligibility Criteria
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Healthy Volunteers: Inclusion Criteria: Subjects must be ≥30 and ≤75 years of age; Subjects must provide informed consent prior to study procedures; Exclusion Criteria: History of CAD, including: Prior abnormal myocardial perfusion study History of MI History of angina Coronary artery obstruction >50% on CTA and/or angiography Left ventricular ejection fraction <50% Any relative or absolute contraindication to adenosine stress, including: 2nd or 3rd degree heart block Bradycardia (HR<50 bpm) Recent acute coronary syndrome (ACS) Unstable angina Severe heart failure (left ventricular ejection fraction <15%) Ventricular arrhythmia Severe asthma and/or chronic obstructive pulmonary disease (COPD) Baseline hypotension defined as systolic blood pressure < 90 mmHg Caffeine intake within 24 hours prior to imaging Current use of theophylline, dipyridamole, or carbamazepine Allergy or intolerance to adenosine Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing; Subjects with CAD: Inclusion criteria Subjects must be ≥30 and ≤75 years of age; Subjects must provide informed consent prior to study procedures; Abnormal myocardial perfusion study within the past 12 months Exclusion criteria Revascularization (percutaneous coronary intervention and/or coronary artery bypass) following last myocardial perfusion study Acute coronary syndrome within 30 days Left ventricular ejection fraction <50% Any relative or absolute contraindication to adenosine stress, including: 2nd or 3rd degree heart block Bradycardia (HR<50 bpm) Recent acute coronary syndrome (ACS) Unstable angina Severe heart failure (left ventricular ejection fraction <15%) Ventricular arrhythmia Severe asthma and/or chronic obstructive pulmonary disease (COPD) Baseline hypotension defined as systolic blood pressure < 90 mmHg Caffeine intake within 24 hours prior to imaging Current use of theophylline, dipyridamole, or carbamazepine Allergy or intolerance to adenosine Any clinically significant acute or unstable physical or psychological disease, judged by the investigators, to be incompatible with the study; Radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months); Female participants only: Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing; Inability to provide written informed consent;

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Volunteers<br>Subjects without history of coronary artery disease | Diagnostic Test: Single-Scan Two-Injection Protocol<br>* Single-Scan Two-Injection Protocol<br>|
| Subjects with coronary artery disease<br>Subjects with coronary artery disease and abnormal SPECT myocardial perfusion imaging within the last 12 months | Diagnostic Test: Single-Scan Two-Injection Protocol<br>* Single-Scan Two-Injection Protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress MBF | Difference in stress myocardial blood flow measured by the single-scan two-injection protocol versus conventional single-scan single-injection stress protocol | Single session (<2 hours) |