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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease; Coronary Disease
• Intervention / Treatment: Procedure: Stress ultrasound; Procedure: Scintigraphy; Procedure: Coronary angiography

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes Cedex 09, Gard, France, 30029
      • Centre Hospitalier Universitaire de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Severe coronary artery disease; Patients in this group have coronary artery disease with a stenosis of >70%.	Procedure: Stress ultrasound; 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.; Procedure: Scintigraphy; 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).; Procedure: Coronary angiography; 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)
Other: Coronary artery disease; Patients in this group have coronary artery disease with stenosis < 70%.	Procedure: Stress ultrasound; 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.; Procedure: Scintigraphy; 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).; Procedure: Coronary angiography; 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Madeleine Rubini, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: March 23, 2011
• First Submitted That Met QC Criteria: March 23, 2011
• First Posted (Estimate): March 24, 2011

Study Record Updates

• Last Update Posted (Actual): June 19, 2017
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: AOI/2009/VB-01