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

Primary Purpose

Coronary Artery Disease, Coronary Disease

Status

Withdrawn

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Stress ultrasound

Scintigraphy

Coronary angiography

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Centre Hospitalier Universitaire de Nîmes

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Severe coronary artery disease

Coronary artery disease

Arm Description

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

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

Outcomes

Primary Outcome Measures

The difference between AUCs for multimodal imaging and scintigraphy

Secondary Outcome Measures

The difference between AUCs for multimodal imaging and stress ultrasound

Full Information

NCT ID

NCT01321970

First Posted

March 23, 2011

Last Updated

June 16, 2017

Sponsor

Centre Hospitalier Universitaire de Nīmes

1. Study Identification

Unique Protocol Identification Number

NCT01321970

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Impossible to start to the study.

Study Start Date

June 2013 (Actual)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Coronary Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Severe coronary artery disease

Arm Type

Other

Arm Description

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

Arm Title

Coronary artery disease

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Stress ultrasound

Intervention Description

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

Intervention Name(s)

Scintigraphy

Intervention Description

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

Intervention Name(s)

Coronary angiography

Intervention Description

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)

Primary Outcome Measure Information:

Title

The difference between AUCs for multimodal imaging and scintigraphy

Time Frame

4 days

Secondary Outcome Measure Information:

Title

The difference between AUCs for multimodal imaging and stress ultrasound

Time Frame

4 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Madeleine Rubini, MD

Organizational Affiliation

Centre Hospitalier Universitaire de Nîmes

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Universitaire de Nîmes

City

Nîmes Cedex 09

State/Province

Gard

ZIP/Postal Code

30029

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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