Myocardial Stress Perfusion Imaging With Dual Source CT

Study Overview
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Brief Summary
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The investigators propose a novel technique using dual source multidetector computed tomography (DSCT) where information on both coronary anatomy and myocardial perfusion is obtained in a single scan. The investigators hypothesize that a coronary CTA protocol can be devised to obtain resting myocardial perfusion, myocardial perfusion after stress, and coronary anatomy. Hence, one diagnostic test will be able to detect the presence of coronary plaque as well as assess the functional significance of a stenosis.

Official Title
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Myocardial Stress Perfusion Imaging With Dual Source CT

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Adenosine Stress Dual-source CTP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A prior adenosine or exercise stress SPECT exam with high likelihood of being referred to the cardiac catheterization laboratory for invasive angiogram Age > 40 years old Able to comprehend and sign the consent form. Exclusion Criteria: Acute coronary syndromes (unstable angina, non-ST elevation myocardial infarction, ST elevation myocardial infarction) Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias) Premenopausal women who have a positive pregnancy test. Serum Creatinine level ≥1.5 mg/dl as an indicator of renal insufficiency. Known allergy to iodinated contrast agents Atrial fibrillation Asthma Critical aortic stenosis Systolic blood pressure < 90 mmHg Advanced heart block

Ages Eligible for Study
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Minimum Age: 40 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: Adenosine Stress Dual-source CTP<br>A multiphase adenosine Stress Dual-source stress perfusion computed tomography imaging test, as described above, will be performed in all patients. | Other: Adenosine Stress Dual-source CTP<br>* Adenosine- continuous infusion at 140mcg/ kg/ min for 2.5 min; Iopamidol (IV contrast)- total dose of 150cc; Siemens SOMATOM Definition CT scanner (CT scan radiation) - effective radiation dose of approximately 13mSv (tube voltage 120kV, tube current 340mAs for one retrospectively gated cardiac CT with tube current modulation and two prospectively gated cardiac CTs on a Dual Source scanner) This is an observational trial, and all patients will undergo the Adenosine Stress Dual-source CTP procedure.<br>* Other names: Siemens SOMATOM Definition;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography. | The gold standard for abnormality by CTP is defined as a focal stenosis of >50% at quantitative analysis of invasive coronary angiography images, when performed. | 18 months | 
| Per-Vessel Specificity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography. | The gold standard for abnormality by CTP is defined as stenosis of 50% or more at quantitative analysis of invasive coronary angiography images, when performed. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Per-Patient Correlation Between CTP and SPECT at Stress. | Pearson Correlation between research interpretation of CTP images and SPECT images, both performed during stress. | 18 months | 
| Per-Patient Correlation Between CTP and SPECT at Rest. | Pearson Correlation performed on myocardial abnormalities on CTP and SPECT images, obtained at rest. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Multidetector Computed Tomography, Myocardial Perfusion Imaging