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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This study has been withdrawn prior to enrollment.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:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01321970
First received: March 23, 2011
Last updated: June 16, 2017
Last verified: March 2015
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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: 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 |
Resource links provided by NLM:
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 ]
Secondary Outcome Measures:
- The difference between AUCs for multimodal imaging and stress ultrasound [ Time Frame: 4 days ]
| Enrollment: | 0 |
| Actual Study Start Date: | June 2013 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 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:
|
|
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:
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321970
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
| 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: | June 16, 2017 |
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 September 21, 2017