VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography
NCT ID: NCT03179592
Last Updated: 2020-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
120 participants
OBSERVATIONAL
2017-03-22
2019-02-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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Low-volume contrast media injection protocol
Patients will receive a low-volume contrast media (Ultravist 370Mg I/Ml Solution for Injection) injection protocol that is tailored to a specific tube voltage. Tube voltages will be automatically selected by the scanner to be used for the CCTA acquisition.
Ultravist 370Mg I/Ml Solution for Injection
Reduced contrast-volume injection protocols based on patient specific tube voltage.
Interventions
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Ultravist 370Mg I/Ml Solution for Injection
Reduced contrast-volume injection protocols based on patient specific tube voltage.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject must be 18 - 85 years of age.
3. Subject must provide written informed consent prior to any study-related procedures being performed.
4. Subject must be willing to comply with all clinical study procedures.
Exclusion Criteria
* By testing (serum or urine beta HCG) within 24 hours before study agent administration, or
* By surgical sterilization, or
* Post-menopausal, with minimum one (1) year history without menses.
2. Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that is not 70, 80, 90, 100, 110, 120, or 130 kV.
3. Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that has previously reached the maximum subject number (20 subjects per tube voltage).
4. Subject has an acute psychiatric disorder.
5. Subject is unwilling to comply with the requirements of the protocol.
6. Subject has previously entered this study.
7. Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study.
8. Subject has impaired renal function (creatinine \> 1.5 mg/dl).
9. Subject is in unstable condition.
18 Years
85 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Medical University of South Carolina
OTHER
Responsible Party
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Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Other Identifiers
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Pro00060805
Identifier Type: -
Identifier Source: org_study_id
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