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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01321970
Enrollment
0
Registered
2011-03-24
Start date
2013-06-30
Completion date
2015-12-31
Last updated
2017-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Disease

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.

Interventions

PROCEDUREStress 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.

PROCEDUREScintigraphy

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).

PROCEDURECoronary 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)

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The difference between AUCs for multimodal imaging and scintigraphy4 days

Secondary

MeasureTime frame
The difference between AUCs for multimodal imaging and stress ultrasound4 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026