Ignite Creation Date:
2024-05-06 @ 9:23 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02972242
Status:
COMPLETED
Last Update Posted:
2020-06-22
First Post:
2016-11-18
Brief Title:
Focused Field of View Calcium Scoring Prior to Coronary CT Angiography
Sponsor:
Walter Reed National Military Medical Center
Organization:
Walter Reed National Military Medical Center
Study Overview
Official Title:
Focused Field of View Calcium Scoring Prior to Coronary CT Angiography
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOCUS-CCTA
Brief Summary:
Coronary computed tomography angiography CCTA is a frequently performed test for the diagnosis andor exclusion of coronary artery disease CAD in appropriately selected patients The performance of non-contrast computed tomography for the detection and quantification of coronary calcification is typically performed prior to CCTA in an effort to identify significant calcification which may influence subsequent data acquisition during the CCTA However performance of calcium scoring adds significant radiation and most coronary calcification is proximal in its location potentially visualized using a focused non-contrast scan
The purpose of this study is to prospectively compare the usefulness of a modified non-contrast CT using a significantly shorter scan length and lower radiation parameters as compared to standard coronary artery calcium scanning for the detection of coronary calcification that may influence subsequent CCTA performance
The purpose of this study is to prospectively compare the usefulness of a modified non-contrast CT using a significantly shorter scan length and lower radiation parameters as compared to standard coronary artery calcium scanning for the detection of coronary calcification that may influence subsequent CCTA performance
Detailed Description:
Prior to undergoing CCTA non-contrast CT scanning of the entire heart is usually performed in adults over 50-years of age in order to assess for the presence and severity of coronary artery calcium By providing a modified CT scan with a reduced length the same data can be obtained by the imager to ensure a high quality scan while decreasing the patients overall radiation exposure Our objectives and specific aims to validate our hypothesis include
To assess the impact on CCTA image quality using modified calcium score approach
To determine the rate of changes in the coronary CT angiography acquisition parameters after evaluation of the modified versus standard calcium scoring scout series Significant changes in CCTA acquisition include any of the following as compared to recommended CCTA parameters prior to scout CT performance a change increase or decrease in tube current mA by 50 any change in tube potential kV change tofrom retrospectively-gated CCTA any change in padding acquisition window or changing tofrom a high definition CT scan acquisition
To assess the difference in patient estimated effective radiation exposure mSv between the modified versus standard calcium scoring techniques
To assess the difference in patient estimated effective radiation exposure mSv of the entire CCTA study plus calcium scoring between groups
Study Design Prospective randomized single-center cohort study
Anticipated Requirements
1 Facilities Walter Reed National Military Medical Center
1 Cardiology Clinic
2 Cardiovascular Health and Interventional Radiology Angiography and Recovery CVHIR
3 Radiology Department CT Section
2 Duration of enrollment 12 months
3 Budget no additional budget is needed
Subject Population
1 One hundred seventy-five 175 male and female adult subjects military health beneficiaries age greater than 50 years who are clinically referred for CCTA will be eligible for participation
2 The Walter Reed National Military Medical Center Cardiology Department and Radiology Departments perform multiple clinically appropriate and indicated coronary CTA studies weekly approximately 8-12 which will allow for ease of subject recruitment Although there are other open studies using CCTA in our department there is not a lot of overlap in their requirements and should not prohibit enrollment in our study This study will enroll both men and women of all ethnic origins aged 50 years All subjects will consent for themselves All patients participation in this research and subsequent contribution to our medical knowledge notwithstanding no intent to benefit patients from enrollment is implied or offered Pregnant women will be excluded from enrollment based on
1 Verbal admission of pregnant status OR
2 Positive urine pregnancy test performed within 7 days of CCTA in subjects not previously known to be pregnant
To assess the impact on CCTA image quality using modified calcium score approach
To determine the rate of changes in the coronary CT angiography acquisition parameters after evaluation of the modified versus standard calcium scoring scout series Significant changes in CCTA acquisition include any of the following as compared to recommended CCTA parameters prior to scout CT performance a change increase or decrease in tube current mA by 50 any change in tube potential kV change tofrom retrospectively-gated CCTA any change in padding acquisition window or changing tofrom a high definition CT scan acquisition
To assess the difference in patient estimated effective radiation exposure mSv between the modified versus standard calcium scoring techniques
To assess the difference in patient estimated effective radiation exposure mSv of the entire CCTA study plus calcium scoring between groups
Study Design Prospective randomized single-center cohort study
Anticipated Requirements
1 Facilities Walter Reed National Military Medical Center
1 Cardiology Clinic
2 Cardiovascular Health and Interventional Radiology Angiography and Recovery CVHIR
3 Radiology Department CT Section
2 Duration of enrollment 12 months
3 Budget no additional budget is needed
Subject Population
1 One hundred seventy-five 175 male and female adult subjects military health beneficiaries age greater than 50 years who are clinically referred for CCTA will be eligible for participation
2 The Walter Reed National Military Medical Center Cardiology Department and Radiology Departments perform multiple clinically appropriate and indicated coronary CTA studies weekly approximately 8-12 which will allow for ease of subject recruitment Although there are other open studies using CCTA in our department there is not a lot of overlap in their requirements and should not prohibit enrollment in our study This study will enroll both men and women of all ethnic origins aged 50 years All subjects will consent for themselves All patients participation in this research and subsequent contribution to our medical knowledge notwithstanding no intent to benefit patients from enrollment is implied or offered Pregnant women will be excluded from enrollment based on
1 Verbal admission of pregnant status OR
2 Positive urine pregnancy test performed within 7 days of CCTA in subjects not previously known to be pregnant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None