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

Purpose

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.

Condition	Intervention
Coronary Artery Disease Coronary Disease	Procedure: Stress ultrasound Procedure: Scintigraphy Procedure: Coronary angiography

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Validation and Evaluation of Multimodal Imaging Combining Three-dimensional Ultrasound and Stress Myocardial Scintigraphy in the Diagnosis of Coronary Artery Disease

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Nuclear Scans

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:

The difference between AUCs for multimodal imaging and scintigraphy [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The difference between AUCs for multimodal imaging and stress ultrasound [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Enrollment:	0
Study Start Date:	June 2013
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)
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)

Arms

Assigned Interventions

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)

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)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321970

Locations

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

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Principal Investigator:

Madeleine Rubini, MD

Centre Hospitalier Universitaire de Nîmes

More Information

No publications provided

Responsible Party:	Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:	NCT01321970 History of Changes
Other Study ID Numbers:	AOI/2009/VB-01
Study First Received:	March 23, 2011
Last Updated:	May 16, 2013
Health Authority:	France: Committee for the Protection of Personnes France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013