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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: |
NCT00484380 |
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Date of registration:
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06/06/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Scanner in the Coronary Evaluation
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Scientific title:
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Contribution of the Scanner in the Coronary Evaluation Before Valvular Replacement |
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Date of first enrolment:
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August 2007 |
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Target sample size:
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66 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00484380 |
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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: Single Group 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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Gérard Helft, MD, PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hôpital de la Salpétrière |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients scheduled for valve surgery who need a conventional coronary angiography
- Informed Content
- Patients affiliated to the social security system
Exclusion Criteria:
- Instable condition
- Arrhythmia including atrial fibrillation
- Impaired renal function
- Known contrast allergy
- Patients unable to hold an apnea during 20 seconds
- Pregnancy
- Emergency
- People unable to sign the informed content such as major under supervision
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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Valvular Disease
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Coronary Stenosis
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Intervention(s)
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Procedure: Coronary scanner
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Primary Outcome(s)
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The diagnostic accuracy of coronary scanner (sensitivity, specificity, positive and negative predictive values) in the detection of the coronary stenosis higher than 50%.
[Time Frame: a month at the latest after the signature of consent]
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Secondary Outcome(s)
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The diagnostic accuracy of coronary scanner to detect the patients requiring or not a coronary revascularisation in more of the valvular surgery.
[Time Frame: a month at the latest after the signature of consent]
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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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