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

NCT ID: NCT01321970

Last Updated: 2017-06-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-12-31

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.

Conditions

Coronary Artery Disease; Coronary Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Severe coronary artery disease

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

Group Type: OTHER

Stress ultrasound

Intervention Type: PROCEDURE

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.

Scintigraphy

Intervention Type: PROCEDURE

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).

Coronary angiography

Intervention Type: PROCEDURE

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)

Coronary artery disease

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

Group Type: OTHER

Stress ultrasound

Intervention Type: PROCEDURE

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.

Scintigraphy

Intervention Type: PROCEDURE

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).

Coronary angiography

Intervention Type: PROCEDURE

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)

Interventions

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.

Intervention Type: 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).

Intervention Type: 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)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Madeleine Rubini, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, France

Countries

France

Other Identifiers

AOI/2009/VB-01

Identifier Type: -

Identifier Source: org_study_id