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

This study has been withdrawn prior to enrollment.
(Impossible to start to the study.)
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01321970
First received: March 23, 2011
Last updated: November 18, 2014
Last verified: November 2014

March 23, 2011
November 18, 2014
June 2013
June 2015   (final data collection date for primary outcome measure)
The difference between AUCs for multimodal imaging and scintigraphy [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01321970 on ClinicalTrials.gov Archive Site
The difference between AUCs for multimodal imaging and stress ultrasound [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Coronary Artery Disease
  • Coronary Disease
  • 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)
  • Severe coronary artery disease
    Patients in this group have coronary artery disease with a stenosis of >70%.
    Interventions:
    • Procedure: Stress ultrasound
    • Procedure: Scintigraphy
    • Procedure: Coronary angiography
  • Coronary artery disease
    Patients in this group have coronary artery disease with stenosis < 70%.
    Interventions:
    • Procedure: Stress ultrasound
    • Procedure: Scintigraphy
    • Procedure: Coronary angiography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01321970
AOI/2009/VB-01
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Madeleine Rubini, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP