Ignite Creation Date:
2024-05-06 @ 5:58 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05497466
Status:
UNKNOWN
Last Update Posted:
2022-08-11
First Post:
2022-07-31
Brief Title:
PUMCH Study Into Individualized Scanning for Coronary Artery Disease
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
PUMCH Study Into Individualized Scanning for Coronary Artery Disease
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
NOT_YET_RECRUITING
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:
COE
Brief Summary:
Cardiac computed tomographic angiography CCTA is a non-invasive diagnostic imaging technique for visualization of the coronary arteries and thus frequently used in the evaluation of coronary artery disease CAD CT technology is improving continuously and various technological advances not only increase diagnostic accuracy but also provide a substantial reduction in radiation dose and scan acquisition time These modifications challenge optimal synchronization and timing of scan protocols in CM administration due to a shorter data acquisition window hereby creating opportunities for injection strategies with a decrease in total amount of contrast media CM 4-6 Reducing the radiation dose of CT angiography and injected CM dose have become a routine need and trend in clinical practice In addition to this physical factors such as cardiac output and body weight are considered important factors with regard to variability in vascular enhancement A standard one size fits all protocol with a standard injected CM volume independent of weight and length of the patient has proven to be outdated and precision medicine in the future should be based on individually tailored scan and CM injection protocols that are more scientific and involve various parameters such as individual tube voltage patients weight and heart rate to benefit patients by reducing radiation exposure and CM dose while fulfilling the diagnostic purpose
Prospective studies focused on modifying both scan and injection parameters were completed in the Dutch representing European patient population with body weight varying between 40 and 130kg by Maastricht University Medical Center MUMC and have shown very promising results in Dutch population In theory these scan and injection protocols should be applicable to both average Dutch population eg European population and other heterogeneous patient populations ie world-wide patient populations with any BMI category However so far the effectiveness of this approach has not been deliberately discussed in the on average heavier North American population or the lighter Asian population So prior to promotion of the individually tailored CT scan protocols for global use we need to obtain enough evidence in terms of the diagnostic confidence from those protocols in Chinese patients who could represent Asian population
Prospective studies focused on modifying both scan and injection parameters were completed in the Dutch representing European patient population with body weight varying between 40 and 130kg by Maastricht University Medical Center MUMC and have shown very promising results in Dutch population In theory these scan and injection protocols should be applicable to both average Dutch population eg European population and other heterogeneous patient populations ie world-wide patient populations with any BMI category However so far the effectiveness of this approach has not been deliberately discussed in the on average heavier North American population or the lighter Asian population So prior to promotion of the individually tailored CT scan protocols for global use we need to obtain enough evidence in terms of the diagnostic confidence from those protocols in Chinese patients who could represent Asian population
Detailed Description:
Primary objective To prospectively evaluate the diagnostic quality including the intravascular attenuation of the coronary arteries and image quality in a previously validated individualized scan and CM injection CCTA protocol whereas both scan and injection parameters are tailored to the individual patient in Chinese population
Secondary Objectives
1 To evaluate the radiation dose and contrast media dose of this individualized approach for CCTA in a Chinese patient population
2 To evaluate the injection parameters required for the average patient population
Subjects will be screened according to clinical data and enrolled in the study after providing informed consent Patients will be scanned by Siemens Force CT scanner prospective ECG gate-control and narrow window scanning technology as well as intelligent KV CARE-KV Tech scanning technology The CARE-kV software will determine optimal scan parameters for each patient without any human intervention By this means each patient will be included in a specific tube-voltage arm based on in the condition of individual patient
Care kV is a software that collects information about the patients own attenuation values x-ray absorption during a so-called scout scan Based on these parameters and taking into account the required scan quality eg parenchymal bone or vascular the software determines the optimal scan settings for the patient This includes both a variable tube current in mAs along the z-axis of the patient and an individual tube voltage in kV The tube voltage can be selected between 70 and 150kV in steps of 10kV For this study the scan quality slider will be set to vascular or 11 which is commonly used in clinical studies and clinical practice for CCTA
Iopromide injection iodine concentration 370 mgIml Ultravist Bayer Healthcare Berlin Germany is administered as a bolus through the cubital vein using dual-syringe high-pressure injector CT high-pressure injector Stellant MEDRAD Pittsburg PA USA The CM injection parameters are computed according to patient and examination-related parameters patient weight CM concentration scan duration and maximum flow rate using the Personalized Patients Protocol Technology P3T software supplied in the high-pressure injector
P3T Personalized Patient Protocol Technology software computes individualized contrast injection protocols P3T CardiacPulmonary arteries are indicated for use with CAT of the cardiac structures coronary arteries chambers of the heart pulmonary vasculature thoracic and abdominal aorta During initial setup options such as minimum and maximum iodine loads minimum injection duration and other settings are configured according to site preferences and guidelines These options are stored as a preset which can then be selected to calculate an injection protocol At that time patient and procedure specific parameters patient weight CM concentration scan duration and maximum flow rate are entered by the radiographer The software calculates the iodine load by multiplying the patient weight by a pre-determined dosing factor applying the configured minimums and maximums Then the injection duration is determined based on the duration of the scan and minimum injection duration Using the iodine load injection duration and CM concentration the individualized flow rate and CM volumes are computed The radiographer may edit the injection protocol if necessary Dosing factors were derived based on pharmacokinetic model to simulate vascular enhancement in the regions of interest targeting 350-400 HU across a wide range of patients
An 18G or 20G venous access in the antecubital vein is preferred for higher flow rates If low flow rates are required venous access through an IV needle as small as 22G max flow 65 mLsec may be used
Test bolus saline flush next CM bolus and saline flush 40ml Prewarmed 37 ยบ C 99F CM Iopromide 370mgIml Bayer
Injection using a programmable dual-head CT injector Stellant Bayer via an 18-20G intravenous injection catheter in the left or right antecubital vein We propose to use the appropriate gauge for the expected flow rate according to local safety regulations
P3T Cardiac Certegra Use patient body weight adjusted protocol P3T Cardiac Certegra This will show flow rates if one sets the injection time and contrast media concentration
Adjust for selected kV setting by adapting the IDR -10 for 110kV -20 for 100kV -30 for 90kV -40 for 80kV and -50 for 70kV
In all patients a test bolus injection at the level of the ascending aorta is performed to assess optimal start delay 20ml of CM at a flow rate according to P3T protocol Test bolus is followed by 40ml of saline flush at the same flow rate
Study archiving patient protocol radiation dose information ECG information contrast media information scout views calcium score scan heart scan Bv40 06mm slices
For this study we chose to include 300 patients to ensure a representation of normal patient variance Given the assumed non-diagnostic rate to be around 5 the 95 CI of non-diagnostic rate with 300 sample size is 28 81 Although there is no hypothesis test planned for this study the result from a recent published study taking similar design on individualized scan and injection protocol of liver CT provides support on adequate sample size of the current study Based on the study 256 patients in total could enable the stratification performed based on age 60 and 60 years and weight 75 and 75 kg in the population weighed below 115 kg
If 300 patients are not included after 18 months the inclusion period will be over none the less
Secondary Objectives
1 To evaluate the radiation dose and contrast media dose of this individualized approach for CCTA in a Chinese patient population
2 To evaluate the injection parameters required for the average patient population
Subjects will be screened according to clinical data and enrolled in the study after providing informed consent Patients will be scanned by Siemens Force CT scanner prospective ECG gate-control and narrow window scanning technology as well as intelligent KV CARE-KV Tech scanning technology The CARE-kV software will determine optimal scan parameters for each patient without any human intervention By this means each patient will be included in a specific tube-voltage arm based on in the condition of individual patient
Care kV is a software that collects information about the patients own attenuation values x-ray absorption during a so-called scout scan Based on these parameters and taking into account the required scan quality eg parenchymal bone or vascular the software determines the optimal scan settings for the patient This includes both a variable tube current in mAs along the z-axis of the patient and an individual tube voltage in kV The tube voltage can be selected between 70 and 150kV in steps of 10kV For this study the scan quality slider will be set to vascular or 11 which is commonly used in clinical studies and clinical practice for CCTA
Iopromide injection iodine concentration 370 mgIml Ultravist Bayer Healthcare Berlin Germany is administered as a bolus through the cubital vein using dual-syringe high-pressure injector CT high-pressure injector Stellant MEDRAD Pittsburg PA USA The CM injection parameters are computed according to patient and examination-related parameters patient weight CM concentration scan duration and maximum flow rate using the Personalized Patients Protocol Technology P3T software supplied in the high-pressure injector
P3T Personalized Patient Protocol Technology software computes individualized contrast injection protocols P3T CardiacPulmonary arteries are indicated for use with CAT of the cardiac structures coronary arteries chambers of the heart pulmonary vasculature thoracic and abdominal aorta During initial setup options such as minimum and maximum iodine loads minimum injection duration and other settings are configured according to site preferences and guidelines These options are stored as a preset which can then be selected to calculate an injection protocol At that time patient and procedure specific parameters patient weight CM concentration scan duration and maximum flow rate are entered by the radiographer The software calculates the iodine load by multiplying the patient weight by a pre-determined dosing factor applying the configured minimums and maximums Then the injection duration is determined based on the duration of the scan and minimum injection duration Using the iodine load injection duration and CM concentration the individualized flow rate and CM volumes are computed The radiographer may edit the injection protocol if necessary Dosing factors were derived based on pharmacokinetic model to simulate vascular enhancement in the regions of interest targeting 350-400 HU across a wide range of patients
An 18G or 20G venous access in the antecubital vein is preferred for higher flow rates If low flow rates are required venous access through an IV needle as small as 22G max flow 65 mLsec may be used
Test bolus saline flush next CM bolus and saline flush 40ml Prewarmed 37 ยบ C 99F CM Iopromide 370mgIml Bayer
Injection using a programmable dual-head CT injector Stellant Bayer via an 18-20G intravenous injection catheter in the left or right antecubital vein We propose to use the appropriate gauge for the expected flow rate according to local safety regulations
P3T Cardiac Certegra Use patient body weight adjusted protocol P3T Cardiac Certegra This will show flow rates if one sets the injection time and contrast media concentration
Adjust for selected kV setting by adapting the IDR -10 for 110kV -20 for 100kV -30 for 90kV -40 for 80kV and -50 for 70kV
In all patients a test bolus injection at the level of the ascending aorta is performed to assess optimal start delay 20ml of CM at a flow rate according to P3T protocol Test bolus is followed by 40ml of saline flush at the same flow rate
Study archiving patient protocol radiation dose information ECG information contrast media information scout views calcium score scan heart scan Bv40 06mm slices
For this study we chose to include 300 patients to ensure a representation of normal patient variance Given the assumed non-diagnostic rate to be around 5 the 95 CI of non-diagnostic rate with 300 sample size is 28 81 Although there is no hypothesis test planned for this study the result from a recent published study taking similar design on individualized scan and injection protocol of liver CT provides support on adequate sample size of the current study Based on the study 256 patients in total could enable the stratification performed based on age 60 and 60 years and weight 75 and 75 kg in the population weighed below 115 kg
If 300 patients are not included after 18 months the inclusion period will be over none the less
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