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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00350506 |
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Date of registration:
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06/07/2006 |
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Primary sponsor: |
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Public title:
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A Trial Evaluating the Clinical Applicability, Correlation, and Modeling of Cardiac CT Using 64 Detector Row VCT
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Scientific title:
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An Open-Label, Non-Randomized, Multi-Center Trial Evaluating the Clinical Applicability, Correlation, and Modeling of Cardiac CT Using 64 Detector Row VCT |
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Date of first enrolment:
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October 2005 |
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Target sample size:
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144 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00350506 |
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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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Countries of recruitment
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United States
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Contacts
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Name:
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Robert Centofanti, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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GE Healthcare |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients scheduled for elective diagnostic catheterization OR
- Elective diagnostic catheterization has been performed within the past 2 weeks but no
less than 24 hours prior to the coronary CTA procedure with no intervention performed
or change of the patient clinical status.
- Age =18 years but =75 years.
Exclusion Criteria:
- Prior coronary stent implantation
- Prior coronary artery bypass grafting or other heart surgery
- Prior pacemaker or internal defibrillator lead implantation
- Prior artificial heart valve
- Biochemical renal insufficiency (CrSerum > 1.6) or on dialysis
- Resting HR > 100 at the time of enrollment
- Contraindication to ß-blockade or calcium channel blocker
- NYHA-IV
- High-grade atrioventricular (AV) block
- Systolic blood pressure <90 mm Hg
- Severe asthma or active bronchospasm and/or chronic obstructive pulmonary
disease
- Atrial fibrillation
- Inability to provide informed consent
- Evidence of ongoing or active clinical instability
- Acute chest pain (sudden onset)
- Acute myocardial infarction
- Cardiac shock
- Acute pulmonary edema
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Intervention(s)
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Device: 64 Channel VCT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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