Ignite Creation Date:
2024-05-06 @ 10:35 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03292354
Status:
COMPLETED
Last Update Posted:
2019-03-21
First Post:
2017-09-20
Brief Title:
Personalization of CM Injection Protocols in Coronary Computed Tomographic Angiography
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Personalization of CM Injection Protocols in Coronary Computed Tomographic Angiography
Status:
COMPLETED
Status Verified Date:
2019-03
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:
PeopleCT
Brief Summary:
Cardiac computed tomography CCT is one of the standard non-invasive imaging techniques allowing imaging of the heart and coronary arteries with a high temporal and spatial resolution The high sensitivity and negative predictive value NPV of coronary CT angiography CCTA make it a valuable tool in the assessment of coronary artery disease CAD in patients with low to intermediate risk for CAD especially to rule out CAD This risk stratification can be done with help of multiple different risk-calculators eg the updated Diamond-Forrester model by Genders et al 2012 These calculators take different variables into account eg advanced age gender blood pressure diabetes mellitus DM lipid profile and smoking
The aim of CCTA is a high diagnostic accuracy which depends on both optimal intravascular enhancement in Hounsfield Units minimal 325 HU and contrast-to-noise ratio CNR Optimal intravascular enhancement and CNR depend on different factors such as scan technique eg tube voltage tube potential parameters of the administered contrast material CM and patient related factors eg cardiac output CO body weight BW
Patients with cardiac diseases often have multiple risk factors for developing contrast induced nephropathy CIN eg diabetes mellitus advanced age hypertension and chronic kidney disease Although the relationship between CTA and CIN has recently come to discussion AMACING trial Nijssen et al 2017 it is still desirable to minimise the CM volume used in these patients One method to reduce the CM volume is to personalise the injection protocols The personalisation of injection protocols to the individual patient is gaining more attention in the field of CT imaging The goal is to individualise the injection protocols to a level where the patient only receives the minimal amount of CM needed to acquire a diagnostic scan while maintaining a diagnostic image quality Many techniques are available and have been studied eg adjustment of CM volume to scan protocol CO lean body weight LBW and BW
However no data is available on which of these is the most beneficial method for the personalisation of CM injection protocols Therefore the aim of this study is to assess the performance of three different personalized injection protocols based on CO LBW and BW in CCTA with regard to image quality in comparison to previously used protocols in our department We hypothesize that the personalized injection protocols will be non-inferior provide a homogenous coronary enhancement less non-diagnostic scans in patients and will account for a reduction of CM volume in our department in comparison to the previously used protocols
The aim of CCTA is a high diagnostic accuracy which depends on both optimal intravascular enhancement in Hounsfield Units minimal 325 HU and contrast-to-noise ratio CNR Optimal intravascular enhancement and CNR depend on different factors such as scan technique eg tube voltage tube potential parameters of the administered contrast material CM and patient related factors eg cardiac output CO body weight BW
Patients with cardiac diseases often have multiple risk factors for developing contrast induced nephropathy CIN eg diabetes mellitus advanced age hypertension and chronic kidney disease Although the relationship between CTA and CIN has recently come to discussion AMACING trial Nijssen et al 2017 it is still desirable to minimise the CM volume used in these patients One method to reduce the CM volume is to personalise the injection protocols The personalisation of injection protocols to the individual patient is gaining more attention in the field of CT imaging The goal is to individualise the injection protocols to a level where the patient only receives the minimal amount of CM needed to acquire a diagnostic scan while maintaining a diagnostic image quality Many techniques are available and have been studied eg adjustment of CM volume to scan protocol CO lean body weight LBW and BW
However no data is available on which of these is the most beneficial method for the personalisation of CM injection protocols Therefore the aim of this study is to assess the performance of three different personalized injection protocols based on CO LBW and BW in CCTA with regard to image quality in comparison to previously used protocols in our department We hypothesize that the personalized injection protocols will be non-inferior provide a homogenous coronary enhancement less non-diagnostic scans in patients and will account for a reduction of CM volume in our department in comparison to the previously used protocols
Detailed Description:
Cardiac diseases still are the leading cause of death in the western world Besides the high mortality of the cardiac disease itself recent studies have shown an increasing evidence of the prognostic value of cardiac diseases particularly coronary artery disease CAD in a broad variety of other diseases Especially in patients with oncological pathologies undergoing radiotherapy or lung resection surgery Ambrogi et al 2003 Kanzaki et al 2017 Khakoo et al 2008 Basacaraju et al 2002 Fajardo et al 1972 Cardiac computed tomography angiography CCTA is one of the standard non-invasive imaging techniques allowing imaging of the heart and coronary arteries with a high temporal and spatial resolution The high sensitivity and negative predictive value NPV of CCTA make it a valuable tool in the assessment of CAD Especially to rule out CAD in patients with low to intermediate risk for CAD Hendel et al 2006 Goldstein et al 2011 Budoff et al 2008 Meijboom et al 2008 Roffi et al 2016
The aim of CCTA is to achieve a high diagnostic accuracy which depends on both optimal intravascular enhancement in Hounsfield Units HU minimal 325 HU and contrast-to-noise ratio CNR Optimal intravascular enhancement and CNR depend on multiple factors such as scan technique eg tube voltage kV and tube potential parameters of the administered contrast material CM eg concentration flow rate and patient related factors eg body weight BW heart rate or cardiac output CO Bae et al 2004 Awai et al 2004 Dedicated CT protocols are necessary to image the heart and the coronary arteries These protocols require a correlation to the patients electrocardiogram ECG in order to minimize cardiac motion and deliver a sharp image of the heart and coronary arteries Depending on the heart rate of the patient the scan can either be a prospectively ECG-triggered high-pitch or adaptive sequence or retrospectively ECG-gated helical scan
Patients with cardiac diseases often have multiple risk factors for developing contrast induced nephropathy CIN eg diabetes mellitus DM advanced age hypertension cardiovascular disease and chronic kidney disease Although the relationship between CTA and CIN has recently come to discussion AMACING trial Nijssen et al 2017 it is still desirable to minimise the CM volume used in these patients Multiple strategies have been studied to reduce CM volume in CTA imaging Kok et al 2016 Kok et al 2015 Kok et al 2016 Kok et al 2016 Mihl et al 2016 Seehofnerova et al 2015 Hendriks et al 2016 For instance lowering tube voltage to achieve a higher attenuation the latter explained by the fact that mean photon energy of lower tube voltage settings in the x-ray beam moves closer to the K-edge of iodine 332 keV
The personalisation of injection protocols to the individual patient is gaining more attention in CT imaging and the goal is to individualise the injection protocols to a level where the patient only receives the minimal amount of CM needed to make a diagnostic scan with a diagnostic image quality Besides the techniques mentioned above other techniques are possible eg adjustment according to patients CO lean body weight LBW and BW
Both blood volume and CO increase with an increasing BW When CO increases the distribution of CM is also increased On one hand this results in a fastened test bolus arrival on the other hand in a decreased and shortened intravascular attenuation profile in comparison to a decreased CO Bae KT 2010 Therefore both timing and CM volume can be adjusted to CO in order to achieve a similar intravascular attenuation profile
LBW is a measurement for body fat percentage It is known that fatty tissue is not as well vascularised in comparison to muscle tissue Thus with increasing BW due to fatty tissue the blood volume does not increase linear to BW For instance patients with a high BW due to increased muscle tissue need more CM volume compared to patients with a high BW due to fatty tissue The concept of LBW accounts for this fact Bae KT 2010
When adjusting CM volume to BW less CM volume is needed with a lower BW in comparison to a higher BW due to the decreased blood volume and CO Bae KT 2010
The tube voltage set by automated tube voltage selection ATVS CAREkV Siemens Berlin Germany needs to be taken into account as well CAREkV is a software program which chooses the optimal tube voltage kV and tube current mAs settings for the individual patient based on their topograms while maintaining a diagnostic image quality Lower kV settings result in a higher intravascular enhancement if the same amount of CM is used thus giving the potential to decrease CM volume in lower kV settings
Since no data exist on the optimal method of choice the aim of this study is to assess the performance of three personalized injection protocols CO LBW and BW in CCTA in comparison to previously used protocols with regard to image quality Secondly we want to assess the presence and severity of CAD in patients undergoing CCTA with help of the coronary artery disease reporting and data system CAD-RADS
A total of 330 patients will be included in this prospectively observer blinded randomized controlled non-inferiority trial All patients will be randomised in one of three groups CO LBW and BW with help of a randomisation software program ALEA The control group will consist of 110 consecutive patients who will be included retrospectively
The aim of CCTA is to achieve a high diagnostic accuracy which depends on both optimal intravascular enhancement in Hounsfield Units HU minimal 325 HU and contrast-to-noise ratio CNR Optimal intravascular enhancement and CNR depend on multiple factors such as scan technique eg tube voltage kV and tube potential parameters of the administered contrast material CM eg concentration flow rate and patient related factors eg body weight BW heart rate or cardiac output CO Bae et al 2004 Awai et al 2004 Dedicated CT protocols are necessary to image the heart and the coronary arteries These protocols require a correlation to the patients electrocardiogram ECG in order to minimize cardiac motion and deliver a sharp image of the heart and coronary arteries Depending on the heart rate of the patient the scan can either be a prospectively ECG-triggered high-pitch or adaptive sequence or retrospectively ECG-gated helical scan
Patients with cardiac diseases often have multiple risk factors for developing contrast induced nephropathy CIN eg diabetes mellitus DM advanced age hypertension cardiovascular disease and chronic kidney disease Although the relationship between CTA and CIN has recently come to discussion AMACING trial Nijssen et al 2017 it is still desirable to minimise the CM volume used in these patients Multiple strategies have been studied to reduce CM volume in CTA imaging Kok et al 2016 Kok et al 2015 Kok et al 2016 Kok et al 2016 Mihl et al 2016 Seehofnerova et al 2015 Hendriks et al 2016 For instance lowering tube voltage to achieve a higher attenuation the latter explained by the fact that mean photon energy of lower tube voltage settings in the x-ray beam moves closer to the K-edge of iodine 332 keV
The personalisation of injection protocols to the individual patient is gaining more attention in CT imaging and the goal is to individualise the injection protocols to a level where the patient only receives the minimal amount of CM needed to make a diagnostic scan with a diagnostic image quality Besides the techniques mentioned above other techniques are possible eg adjustment according to patients CO lean body weight LBW and BW
Both blood volume and CO increase with an increasing BW When CO increases the distribution of CM is also increased On one hand this results in a fastened test bolus arrival on the other hand in a decreased and shortened intravascular attenuation profile in comparison to a decreased CO Bae KT 2010 Therefore both timing and CM volume can be adjusted to CO in order to achieve a similar intravascular attenuation profile
LBW is a measurement for body fat percentage It is known that fatty tissue is not as well vascularised in comparison to muscle tissue Thus with increasing BW due to fatty tissue the blood volume does not increase linear to BW For instance patients with a high BW due to increased muscle tissue need more CM volume compared to patients with a high BW due to fatty tissue The concept of LBW accounts for this fact Bae KT 2010
When adjusting CM volume to BW less CM volume is needed with a lower BW in comparison to a higher BW due to the decreased blood volume and CO Bae KT 2010
The tube voltage set by automated tube voltage selection ATVS CAREkV Siemens Berlin Germany needs to be taken into account as well CAREkV is a software program which chooses the optimal tube voltage kV and tube current mAs settings for the individual patient based on their topograms while maintaining a diagnostic image quality Lower kV settings result in a higher intravascular enhancement if the same amount of CM is used thus giving the potential to decrease CM volume in lower kV settings
Since no data exist on the optimal method of choice the aim of this study is to assess the performance of three personalized injection protocols CO LBW and BW in CCTA in comparison to previously used protocols with regard to image quality Secondly we want to assess the presence and severity of CAD in patients undergoing CCTA with help of the coronary artery disease reporting and data system CAD-RADS
A total of 330 patients will be included in this prospectively observer blinded randomized controlled non-inferiority trial All patients will be randomised in one of three groups CO LBW and BW with help of a randomisation software program ALEA The control group will consist of 110 consecutive patients who will be included retrospectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None