Validation/Evaluation of Multimodal Imaging Combining 3D Ultrasound and Stress Myocardial Scintigraphy in the Diagnosis of Coronary Artery Disease

Study Overview
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Brief Summary
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Our primary goal is to validate a new diagnostic tool for functional coronary artery stenosis that uses multimodal imaging (combining stress echocardiography and stress scintigraphy) in patients with known coronary chest pain.

Official Title
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Validation and Evaluation of Multimodal Imaging Combining Three-dimensional Ultrasound and Stress Myocardial Scintigraphy in the Diagnosis of Coronary Artery Disease

Conditions
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Coronary Artery Disease, Coronary Disease

Intervention / Treatment
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* Procedure: Stress ultrasound
* Procedure: Scintigraphy
* Procedure: Coronary angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient has a documented coronaropathy The patient needs a new coronarography following symptoms indicating a change in his/her coronary disease state Exclusion Criteria: The patient is participating in another study The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant The patient is breastfeeding Patients with arrhythmias, left bundle branch block on the electrocardiogram which would complicate the interpretation of examinations Unstable, acute coronary syndromes unstable needing emergency coronary angiography Patient with contraindication for conducting a stress test: poorly controlled hypertension pre-existing severe arrhythmia aortic stenosis and obstructive hypertrophic cardiomyopathy Patient has contraindication for atropine History of prostate adenoma Glaucoma
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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Severe coronary artery disease<br>Patients in this group have coronary artery disease with a stenosis of >70%. | Procedure: Stress ultrasound<br>* Qualitative interpretation of the left ventricular wall motion abnormalities is performed in real time in the resting phase and during pharmacological stress. The translation of quantitative data is then performed for each of the 17 segments on a bulls-eye pattern identical to that of scintigraphy.<br>Procedure: Scintigraphy<br>* Image acquisition is synchronized to the electrocardiogram. The tomographic sections are represented in the 3 directions of space, the analysis is also done on the classical representation in 17 segments. (Typically used in ultrasound perfusion scintigraphy or PET).<br>Procedure: Coronary angiography<br>* Performed in interventional cardiology setting using a guide introduced through the radial or femoral artery. The injection of iodine allows opacification of coronary arteries and their visualization by fluoroscopy. The qualitative interpretation of the data is translated in terms of percentage of stenosis of the coronary artery. It is thus considered that the stenosis is significant at over 70% obstruction of the lumenal diameter. This interpretation is made for each of the three main coronary arteries and their tributaries: Right coronary (proximal, middle and distal) and collateral (inter ventricular posterior ventricular posterior retro) Inter ventricular anterior (proximal, middle and distal) and its tributaries (diagonal and septal) Circumflex (proximal, middle and distal) and collateral (first and second marginal)<br>|
| Other: Coronary artery disease<br>Patients in this group have coronary artery disease with stenosis < 70%. | Procedure: Stress ultrasound<br>* Qualitative interpretation of the left ventricular wall motion abnormalities is performed in real time in the resting phase and during pharmacological stress. The translation of quantitative data is then performed for each of the 17 segments on a bulls-eye pattern identical to that of scintigraphy.<br>Procedure: Scintigraphy<br>* Image acquisition is synchronized to the electrocardiogram. The tomographic sections are represented in the 3 directions of space, the analysis is also done on the classical representation in 17 segments. (Typically used in ultrasound perfusion scintigraphy or PET).<br>Procedure: Coronary angiography<br>* Performed in interventional cardiology setting using a guide introduced through the radial or femoral artery. The injection of iodine allows opacification of coronary arteries and their visualization by fluoroscopy. The qualitative interpretation of the data is translated in terms of percentage of stenosis of the coronary artery. It is thus considered that the stenosis is significant at over 70% obstruction of the lumenal diameter. This interpretation is made for each of the three main coronary arteries and their tributaries: Right coronary (proximal, middle and distal) and collateral (inter ventricular posterior ventricular posterior retro) Inter ventricular anterior (proximal, middle and distal) and its tributaries (diagonal and septal) Circumflex (proximal, middle and distal) and collateral (first and second marginal)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between AUCs for multimodal imaging and scintigraphy |  | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between AUCs for multimodal imaging and stress ultrasound |  | 4 days |