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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01321970
• Other study ID #: AOI/2009/VB-01
• Status: Withdrawn
• Phase: N/A
• First received: March 23, 2011
• Last updated: June 16, 2017
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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).
• 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)

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nîmes	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference between AUCs for multimodal imaging and scintigraphy		4 days
Secondary	The difference between AUCs for multimodal imaging and stress ultrasound		4 days