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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00305916 |
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Date of registration:
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21/03/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Multislice Spiral Computed Tomography and Cardiomyopathy
CMD-scanner |
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Scientific title:
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Accuracy of Multislice Spiral Computed Tomography in Diagnosis of Coronary Artery Disease Associated to Idiopathic Cardiomyopathy in Sinus Rhythm ("MSCT-IC Study"). |
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Date of first enrolment:
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February 2006 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00305916 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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David Veillard, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rennes University Hospital |
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Name:
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Bruno Laviolle, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rennes University Hospital |
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Name:
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Dominique Boulmier, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rennes University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients scheduled to undergo coronary angiography,
- etiologic diagnosis of idiopathic cardiomyopathy (defined by a left ventricle
echographic ejection fraction = 40 %, without anamnestic or electrocardiographic
arguments in favour of coronary artery disease),
- in sinus rhythm,
- informed written consent.
Exclusion Criteria:
- allergy to iodine,
- history of coronary artery bypass graft,
- history of percutaneous coronary angioplasty,
- history of myocardial infarction,
- known coronary artery disease,
- Q waves on the ECG,
- unstable haemodynamic status,
- urgent revascularisation or urgent valvular surgery,
- heart rate > 80 bpm (before MSCT),
- pregnancy,
- enrollment in another study.
- severe renal or respiratory insufficiency.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiomyopathies
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Intervention(s)
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Procedure: Multislice spiral computed tomography coronary angiography
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Procedure: conventional coronary angiography
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Primary Outcome(s)
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Detection of > 50% coronary stenosis
[Time Frame: During assessment]
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Sensibility, specificity, positive and negative predictive values of MSCT
[Time Frame: During assessment]
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Secondary Outcome(s)
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Detection of patients with 3-vessel disease
[Time Frame: During assessment]
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Detection of patients with one or more coronary stenosis
[Time Frame: During assessment]
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Detection of coronary sinus branches
[Time Frame: During assessment]
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Posterior wall telediastolic thickness
[Time Frame: During assessment]
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Assessment of renal function 7 days after MSCT
[Time Frame: During assessment]
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Left ventricle telediastolic diameter
[Time Frame: During assessment]
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Measurement of coronary sinus branches diameter
[Time Frame: During assessment]
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Septal telediastolic thickness
[Time Frame: During assessment]
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Secondary ID(s)
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CIC0203/045
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AFSSAPS 2005/06/004
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LOC/04-05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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