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NCT01534975 · ClinicalTrials.gov registry record · NA
Comparison of Contrast Agents During CT Angiography
A NA study, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 513
- Enrollment target
NCT01534975 is a NA study that has completed, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. The registered enrollment target is 513 participants.
The verdict
NCT01534975, a NA study, has completed, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 513 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the effects of a certain contrast agent (iodixanol) to two other commonly used contrast agents called Iopamidol (Isovue) and iohexol (Omnipaque), on heart and kidney safety in patients undergoing a cardiac CT angiogram. The investigators will evaluate whether iodixanol 320 (Visipaque®), an iso-osmolar agent, is better tolerated (flushing, injection site pain/warmth, headache, nausea) and provides equal image quality compared with iohexol 350 (Omnipaque®) and Isovue 370 during 64-slice multidetector computed tomography angiography (MDCTA). A fourth group (Visipaque 270) will be included, using low radiation dose technology during acquisition, to evaluate image quality, tolerability, and contrast enhancement compared to both Visipaque 320 and Omnipaque and Isovue. In addition to image quality, tolerability, and contrast enhancement, the investigators will evaluate heart rate, adverse events, reimaging, costs, and patient satisfaction among all four cohorts. The study will recruit 400 participants already undergoing CT angiography and consent and randomize them to one of four groups. Each of the possible contrast agents used are commonly used for CT angiography, so the primary risk is loss of confidentiality and being asked questions about tolerability. All other facets of the study (3 lead ECG, beta blockade, nitroglycerine use, CT angiography and contrast administration) are standard of care and being done for clinical uses.
Interventions
- DIAGNOSTIC_TEST contrast agent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 513 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01534975
The ClinicalTrials.gov registry entry for NCT01534975 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 513 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which contrast agent is the first listed.
NCT01534975 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01534975 about?
NCT01534975 is a clinical study titled "Comparison of Contrast Agents During CT Angiography". The purpose of this study is to compare the effects of a certain contrast agent (iodixanol) to two other commonly used contrast agents called Iopamidol (Isovue) and iohexol (Omnipaque), on heart and kidney safety in patients undergoing a cardiac CT angiogram. The investigators will evaluate whether ...
What is the current status of trial NCT01534975?
This trial is currently completed. It is a NA study. The enrollment target is 513 participants. The study started on 2012-01. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01534975?
The interventions under investigation include: contrast agent (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT01534975?
This trial is sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.
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