Screening for Coronary Artery Disease Using Fluoroscopy During Coronary Angiography
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| First Received Date ICMJE | May 10, 2012 | ||||
| Last Updated Date | October 11, 2012 | ||||
| Start Date ICMJE | April 2012 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Measure of radiation exposure to the patient [ Time Frame: During coronary angiography ] [ Designated as safety issue: No ] Surface peak skin dose, as measured by the Gafchromic XR RV3 film strip, which is placed under the patient's back during the procedure. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01605045 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Screening for Coronary Artery Disease Using Fluoroscopy During Coronary Angiography | ||||
| Official Title ICMJE | Efficacy of Fluoroscopy-save Function During Cardiac Catheterization | ||||
| Brief Summary | The aim of this study is to evaluate the effects of screening using the fluoroscopy-save function on reduction of radiation exposure and quality of angiogram during cardiac catheterization when compared to traditional cinematography-guided coronary angiography. |
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| Detailed Description | The study will be a prospective, randomized study of patients undergoing clinically-indicated coronary angiograpy in the New York University (NYU) Langone Medical Center cardiac catheterization laboratory. Patients will be randomized to one of two coronary angiography protocols: (1) Coronary anatomy visualized under fluoroscopy, documented using the fluoroscopy-save function, and further visualized using cinematography only when higher quality is necessary (fluoroscopy-save technique) versus (2) Coronary anatomy visualized and documented using cinematography alone (standard technique). The primary outcome will be a measure of radiation exposure to the patient, surface peak skin dose, as measured by the Gafchromic XR RV3 film strip, which is placed under the patient's back during the procedure. Other outcome measures will include radiation output recorded by the fluoroscopy machine, amount of contrast used, and quality of angiograms performed. To determine if the quality of the angiograms performed using the fluoroscopy-save technique is non-inferior to the standard technique, one extra picture will be taken at random using the mode that the study was not randomized to. For example, in the fluoroscopy-save group, a picture that was not visualized under cinematography during the study will be repeated and documented under cinematograpy. In the standard group, a picture will be repeated and documented using the fluoroscopy-save function. These 2 pictures from each study will then be collated and put together in no particular order with all identifiers removed. These single pictures will be read by 2 interventional cardiologists not involved in the study in a blinded fashion. The degree of coronary artery disease as determined by these 2 readers will be compared between the fluoroscopy-save picture and cinematography picture. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Coronary Artery Disease | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | September 2012 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01605045 | ||||
| Other Study ID Numbers ICMJE | S12-00007 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | James Slater, New York University School of Medicine | ||||
| Study Sponsor ICMJE | New York University School of Medicine | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | New York University School of Medicine | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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