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

Not Applicable

Withdrawn

• Conditions: Coronary Artery Disease; Coronary Disease
• Interventions: Procedure: Stress ultrasound; Procedure: Scintigraphy; Procedure: Coronary angiography

• Registration Number: NCT01321970
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-23
• Study First Posted: 2011-03-24
• Study Start: 2013-06
• Status Verified: 2015-03
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coronary artery disease	Stress ultrasound	Patients in this group have coronary artery disease with stenosis \< 70%.
Severe coronary artery disease	Stress ultrasound	Patients in this group have coronary artery disease with a stenosis of \>70%.
Severe coronary artery disease	Coronary angiography	Patients in this group have coronary artery disease with a stenosis of \>70%.
Severe coronary artery disease	Scintigraphy	Patients in this group have coronary artery disease with a stenosis of \>70%.
Coronary artery disease	Scintigraphy	Patients in this group have coronary artery disease with stenosis \< 70%.
Coronary artery disease	Coronary angiography	Patients in this group have coronary artery disease with stenosis \< 70%.

Primary Outcome Measures

Name	Time	Method
The difference between AUCs for multimodal imaging and scintigraphy	4 days

Secondary Outcome Measures

Name	Time	Method
The difference between AUCs for multimodal imaging and stress ultrasound	4 days

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes Cedex 09, Gard, France