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

Centre Hospitalier Universitaire de Nīmes

Status: Withdrawn

Conditions: Coronary Artery Disease; Coronary Disease

Treatments: Procedure: Stress ultrasound; Procedure: Coronary angiography; Procedure: Scintigraphy

Study type: Interventional

Funder types: Other

Identifiers

NCT01321970

AOI/2009/VB-01

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Severe coronary artery disease

Other group

Description:

Patients in this group have coronary artery disease with a stenosis of \>70%.

Treatment:

Procedure: Stress ultrasound

Procedure: Scintigraphy

Procedure: Coronary angiography

Coronary artery disease

Other group

Description:

Patients in this group have coronary artery disease with stenosis \< 70%.

Treatment:

Procedure: Stress ultrasound

Procedure: Scintigraphy

Procedure: Coronary angiography