Trial Outcomes & Findings for Focused Field of View Calcium Scoring Prior to Coronary CT Angiography (NCT NCT02972242)
NCT ID: NCT02972242
Last Updated: 2020-06-22
Results Overview
The measurement of quality in comparison of the modified versus non-modified CCTA using a qualitative (four point scale). 1. = Nondiagnostic: Impaired image quality that precluded appropriate evaluation of the coronary arteries due to severe motion artifacts, extensive blooming artifact, severe image noise, or insufficient contrast. 2. = Adequate: Reduced image quality because of artifacts due to motion, image noise or low contrast attenuation, but sufficient to rule-out significant stenosis. 3. = Good: Presence of artifacts caused by motion, image noise, coronary calcifications or low contrast, but fully preserved ability to assess the presence of luminal stenosis as well as the presence of calcified and non-calcified coronary atherosclerotic plaque. 4. = Excellent: Complete absence of motion artifacts, strong attenuation of vessel lumen and clear delineation of vessel walls, with the ability to assess stenosis and plaque characteristics.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
175 participants
Primary outcome timeframe
Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Results posted on
2020-06-22
Participant Flow
Participant milestones
| Measure |
Modified Field of View
In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
Standard Field of View
In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
93
|
|
Overall Study
COMPLETED
|
81
|
93
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Modified Field of View
In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
Standard Field of View
In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Focused Field of View Calcium Scoring Prior to Coronary CT Angiography
Baseline characteristics by cohort
| Measure |
Modified Field of View
n=79 Participants
In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
Standard Field of View
n=93 Participants
In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 5.8 • n=99 Participants
|
59 years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
58 years
STANDARD_DEVIATION 6.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
79 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).Population: Within the modified group: 1 patient had previously withdrawn consent and 2 additional scans were subsequently unavailable for review at the time of measurement of the outcomes.
The measurement of quality in comparison of the modified versus non-modified CCTA using a qualitative (four point scale). 1. = Nondiagnostic: Impaired image quality that precluded appropriate evaluation of the coronary arteries due to severe motion artifacts, extensive blooming artifact, severe image noise, or insufficient contrast. 2. = Adequate: Reduced image quality because of artifacts due to motion, image noise or low contrast attenuation, but sufficient to rule-out significant stenosis. 3. = Good: Presence of artifacts caused by motion, image noise, coronary calcifications or low contrast, but fully preserved ability to assess the presence of luminal stenosis as well as the presence of calcified and non-calcified coronary atherosclerotic plaque. 4. = Excellent: Complete absence of motion artifacts, strong attenuation of vessel lumen and clear delineation of vessel walls, with the ability to assess stenosis and plaque characteristics.
Outcome measures
| Measure |
Modified Field of View
n=79 Participants
In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
Standard Field of View
n=93 Participants
In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
|---|---|---|
|
Qualitative Quality Comparison
|
4 score on a scale
Interval 3.0 to 4.0
|
4 score on a scale
Interval 3.0 to 4.0
|
PRIMARY outcome
Timeframe: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).The measurement of quality in comparison of the modified versus non-modified CCTA using a quantitative score (CCTA signal, noise, signal to noise ratio): image signal and noise obtained during scan analysis by placing a circular region of interest (1 cm in diameter) within the proximal ascending aorta and there measuring Hounsfield Units (HU) which is the CCTA "signal" and standard deviation of the HU within that same region (which is the "noise"), the ratio of these signal/noise is also captured by this method.
Outcome measures
| Measure |
Modified Field of View
n=79 Participants
In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
Standard Field of View
n=93 Participants
In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
|---|---|---|
|
Quantitative Quality Comparison
|
16.8 ratio
Standard Deviation 6.1
|
17.9 ratio
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring in a change in milliamps by 50.
Outcome measures
| Measure |
Modified Field of View
n=79 Participants
In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
Standard Field of View
n=93 Participants
In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
|---|---|---|
|
Number of Patients With Coronary CT Parameter Changes (mA by 50).
|
35 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring (i.e. increasing or decreasing the tube potential)
Outcome measures
| Measure |
Modified Field of View
n=79 Participants
In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
Standard Field of View
n=93 Participants
In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
|---|---|---|
|
Number of Patients With Coronary CT Parameter Changes (Tube Potential).
|
23 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).Any use of of the "high definition" scanning parameter after evaluation of the calcium burden by modified or standard calcium scoring.
Outcome measures
| Measure |
Modified Field of View
n=79 Participants
In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
Standard Field of View
n=93 Participants
In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
|---|---|---|
|
Number of Patients With Coronary CT Using High Definition Scanning.
|
7 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring in any changes in padding (milliseconds).
Outcome measures
| Measure |
Modified Field of View
n=79 Participants
In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
Standard Field of View
n=93 Participants
In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
|---|---|---|
|
Number of Patients With Coronary CT Parameter Changes (Padding in Milliseconds).
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).The measurement of radiation exposure as DLP (measured in mSv/mGycm) in comparison of the modified versus standard calcium scoring.
Outcome measures
| Measure |
Modified Field of View
n=79 Participants
In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
Standard Field of View
n=93 Participants
In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
|---|---|---|
|
Comparison Radiation Exposure in Non-Con CT (Dose Length Product)
|
10 mSv/mGycm
Standard Deviation 6
|
53 mSv/mGycm
Standard Deviation 29
|
SECONDARY outcome
Timeframe: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).The measurement of radiation exposure difference measured as DLP/milli-sieverts of the entire CCTA study on the modified versus standard calcium scoring.
Outcome measures
| Measure |
Modified Field of View
n=79 Participants
In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
Standard Field of View
n=93 Participants
In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
|---|---|---|
|
Comparison Radiation Exposure Contrast Coronary CT (Dose Length Product / Milli-sieverts)
|
240 mSv/mGycm
Standard Deviation 137
|
295 mSv/mGycm
Standard Deviation 190
|
SECONDARY outcome
Timeframe: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).Number of patients whose coronary CTA scan was canceled by the imaging provider due to extreme levels of calcium noted during the modified or standard calcium scoring scan.
Outcome measures
| Measure |
Modified Field of View
n=79 Participants
In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
Standard Field of View
n=93 Participants
In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
|
|---|---|---|
|
Number of Participants for Which There Was a Scan Termination Event
|
0 Participants
|
0 Participants
|
Adverse Events
Modified Field of View
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Field of View
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place