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

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ClinicalTrials.gov Identifier: NCT01321970
Recruitment Status : Withdrawn (Impossible to start to the study.)
First Posted : March 24, 2011
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Disease Procedure: Stress ultrasound Procedure: Scintigraphy Procedure: Coronary angiography Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : June 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

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Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. The difference between AUCs for multimodal imaging and scintigraphy [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. The difference between AUCs for multimodal imaging and stress ultrasound [ Time Frame: 4 days ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01321970     History of Changes
Other Study ID Numbers: AOI/2009/VB-01
First Posted: March 24, 2011    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: March 2015

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases