Coronary Artery CalcificationPeopleCTNCT03292354
Personalization of CM Injection Protocols in Coronary Computed Tomographic Angiography
A study testing Contrast media administration in people with Coronary Artery Calcification and Cardiac Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Calcification, Cardiac Disease
- What is being tested?
- Contrast media administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Apr 2017to 14 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for CCTA;
- Age > 18 years;
- Informed consent obtained.
Who cannot join
- Inability to perform a breath hold for the expected scan time;
- Hemodynamic instability;
- Pregnancy;
- Renal insufficiency (defined as glomerular filtration rate (GFR) < 30 mL/min);
- Iodine allergy;
- Age < 18 years;
- Absence of informed consent.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Zuid-Limburg, 6202AZ
About this study
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 (e.g. the updated Diamond-Forrester model by Genders et al. 2012). These calculators take different variables into account, e.g. 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 (e.g. tube voltage, tube potential), parameters of the administered contrast material (CM) and patient related factors (e.g. cardiac output (CO), body weight (BW)).
Read more
Patients with cardiac diseases often have multiple risk factors for developing contrast induced nephropathy (CIN), e.g. 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, e.g. 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.
Read the 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 (e.g. tube voltage (kV) and tube potential), parameters of the administered contrast material (CM) (e.g. concentration, flow rate) and patient related factors (e.g. 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 patient's 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), e.g. 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 (33.2 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, e.g. 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.
- Conditions
- Coronary Artery Calcification, Cardiac Disease
- Being tested
- Contrast media administration
- Keywords
- Coronary Computed Tomography Angiography, Image Quality, Contrast Media Reduction, Personalised Injection Protocols
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast media administrationOther
All patients will receive contrast media with a concentration of 300 mg I/mL (Iopromide 300). The flowrate and volume will be calculated with help of the different formulas belonging to the three different arms.
| Study group | Role | What they receive |
|---|---|---|
| Body Weight (BW) | Active comparator | Patients referred for CCTA in this group receive a personalised contrast media protocol. Contrast media administration based on body weight. Receives: Other: Contrast media administration |
| Cardiac output (CO) | Active comparator | Patients referred for CCTA in this group receive a personalised contrast media protocol. Contrast media administration based on cardiac output. Receives: Other: Contrast media administration |
| Lean Body weight (LBW) | Active comparator | Patients referred for CCTA in this group receive a personalised contrast media protocol. Contrast media administration based on Lean Body Weight. Receives: Other: Contrast media administration |
| Control group | No intervention | Patients in this group will be included retrospectively and have received the standard CM injection protocol previously used in our department. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality
To evaluate the performance of the individualised injection protocols in CCTA, with regard to intravascular attenuation (minimal 325 HU) and compare them with the control group (non-inferiority).
Measured: 1 year
Secondary outcomes (3)
Objective image quality
The performance of the individualised injection protocols in CCTA with regard to objective image quality (image noise, CNR and SNR as calculated from the intravascular enhancement), compared to the standard injection protocol.
Measured: 1 year
subjective image quality
The performance of the individualised injection protocols in CCTA with regard to subjective image quality (4-point Likert scale), compared to the standard injection protocol.
Measured: 1 year
Coronary artery disease
To assess the presence and severity of coronary artery disease (CAD) with help of the CAD-RADS classification
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start11 Apr 2017
- Primary completion14 Sep 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Wildberger, Maastricht University Medical Center
- Investigators
- Joachim E Wildberger, Prof.dr., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292354
- Sponsor's protocol ID
- NL59507.068.16
- Acronym
- PeopleCT
- Status last verified
- Mar 2019
- First submitted
- 20 Sep 2017
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ambrogi V, Pompeo E, Elia S, Pistolese GR, Mineo TC. The impact of cardiovascular comorbidity on the outcome of surgery for stage I and II non-small-cell lung cancer. Eur J Cardiothorac Surg. 2003 May;23(5):811-7. doi: 10.1016/s1010-7940(03)00093-9.
PubMed 12754038Kanzaki R, Inoue M, Minami M, Shintani Y, Funaki S, Kawamura T, Okumura M. Outcomes of lung cancer surgery in patients with coronary artery disease: a decade of experience at a single institution. Surg Today. 2017 Jan;47(1):27-34. doi: 10.1007/s00595-016-1355-z. Epub 2016 May 19.
PubMed 27194125Khakoo AY, Yeh ET. Therapy insight: Management of cardiovascular disease in patients with cancer and cardiac complications of cancer therapy. Nat Clin Pract Oncol. 2008 Nov;5(11):655-67. doi: 10.1038/ncponc1225. Epub 2008 Sep 16.
PubMed 18797437Basavaraju SR, Easterly CE. Pathophysiological effects of radiation on atherosclerosis development and progression, and the incidence of cardiovascular complications. Med Phys. 2002 Oct;29(10):2391-403. doi: 10.1118/1.1509442.
PubMed 12408314Fajardo LF, Stewart JR. Coronary-artery disease after radiation. N Engl J Med. 1972 Jun 8;286(23):1265-6. doi: 10.1056/nejm197206082862315. No abstract available.
PubMed 5022894Hendel RC, Patel MR, Kramer CM, Poon M, Hendel RC, Carr JC, Gerstad NA, Gillam LD, Hodgson JM, Kim RJ, Kramer CM, Lesser JR, Martin ET, Messer JV, Redberg RF, Rubin GD, Rumsfeld JS, Taylor AJ, Weigold WG, Woodard PK, Brindis RG, Hendel RC, Douglas PS, Peterson ED, Wolk MJ, Allen JM, Patel MR; American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group; American College of Radiology; Society of Cardiovascular Computed Tomography; Society for Cardiovascular Magnetic Resonance; American Society of Nuclear Cardiology; North American Society for Cardiac Imaging; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology. ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR 2006 appropriateness criteria for cardiac computed tomography and cardiac magnetic resonance imaging: a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group, American College of Radiology, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, American Society of Nuclear Cardiology, North American Society for Cardiac Imaging, Society for Cardiovascular Angiography and Interventions, and Society of Interventional Radiology. J Am Coll Cardiol. 2006 Oct 3;48(7):1475-97. doi: 10.1016/j.jacc.2006.07.003. No abstract available.
PubMed 17010819Goldstein JA, Chinnaiyan KM, Abidov A, Achenbach S, Berman DS, Hayes SW, Hoffmann U, Lesser JR, Mikati IA, O'Neil BJ, Shaw LJ, Shen MY, Valeti US, Raff GL; CT-STAT Investigators. The CT-STAT (Coronary Computed Tomographic Angiography for Systematic Triage of Acute Chest Pain Patients to Treatment) trial. J Am Coll Cardiol. 2011 Sep 27;58(14):1414-22. doi: 10.1016/j.jacc.2011.03.068.
PubMed 21939822Budoff MJ, Dowe D, Jollis JG, Gitter M, Sutherland J, Halamert E, Scherer M, Bellinger R, Martin A, Benton R, Delago A, Min JK. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol. 2008 Nov 18;52(21):1724-32. doi: 10.1016/j.jacc.2008.07.031.
PubMed 19007693Meijboom WB, Meijs MF, Schuijf JD, Cramer MJ, Mollet NR, van Mieghem CA, Nieman K, van Werkhoven JM, Pundziute G, Weustink AC, de Vos AM, Pugliese F, Rensing B, Jukema JW, Bax JJ, Prokop M, Doevendans PA, Hunink MG, Krestin GP, de Feyter PJ. Diagnostic accuracy of 64-slice computed tomography coronary angiography: a prospective, multicenter, multivendor study. J Am Coll Cardiol. 2008 Dec 16;52(25):2135-44. doi: 10.1016/j.jacc.2008.08.058.
PubMed 19095130Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S. [2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC)]. G Ital Cardiol (Rome). 2016 Oct;17(10):831-872. doi: 10.1714/2464.25804. No abstract available. Italian.
PubMed 27869901Bae KT, Tran HQ, Heiken JP. Uniform vascular contrast enhancement and reduced contrast medium volume achieved by using exponentially decelerated contrast material injection method. Radiology. 2004 Jun;231(3):732-6. doi: 10.1148/radiol.2313030497.
PubMed 15163812Awai K, Hiraishi K, Hori S. Effect of contrast material injection duration and rate on aortic peak time and peak enhancement at dynamic CT involving injection protocol with dose tailored to patient weight. Radiology. 2004 Jan;230(1):142-50. doi: 10.1148/radiol.2301021008.
PubMed 14695390Kok M, Mihl C, Hendriks BM, Altintas S, Kietselaer BL, Wildberger JE, Das M. Optimizing contrast media application in coronary CT angiography at lower tube voltage: Evaluation in a circulation phantom and sixty patients. Eur J Radiol. 2016 Jun;85(6):1068-74. doi: 10.1016/j.ejrad.2016.03.022. Epub 2016 Mar 22.
PubMed 27161054Kok M, Mihl C, Seehofnerova A, Turek J, Jost G, Pietsch H, Haberland U, Wildberger JE, Das M. Automated Tube Voltage Selection for Radiation Dose Reduction in CT Angiography Using Different Contrast Media Concentrations and a Constant Iodine Delivery Rate. AJR Am J Roentgenol. 2015 Dec;205(6):1332-8. doi: 10.2214/AJR.14.13957.
PubMed 26587942Kok M, de Haan MW, Mihl C, Eijsvoogel NG, Hendriks BM, Sailer AM, Derks K, Schnerr RS, Schurink GW, Wildberger JE, Das M. Individualized CT Angiography Protocols for the Evaluation of the Aorta: A Feasibility Study. J Vasc Interv Radiol. 2016 Apr;27(4):531-8. doi: 10.1016/j.jvir.2016.01.009. Epub 2016 Mar 2.
PubMed 26948327
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalization of CM Injection Protocols in Coronary Computed Tomographic Angiography
- ClinicalTrials.gov ID
- NCT03292354
- Acronym / sponsor ID
- PeopleCT / NL59507.068.16
- Conditions
- Coronary Artery Calcification, Cardiac Disease
- Keywords
- Coronary Computed Tomography Angiography, Image Quality, Contrast Media Reduction, Personalised Injection Protocols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (e.g. the updated Diamond-Forrester model by Genders et al. 2012). These calculators take different variables into account, e.g. 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 (e.g. tube voltage, tube potential), parameters of the administered contrast material (CM) and patient related factors (e.g. cardiac output (CO), body weight (BW)).
Patients with cardiac diseases often have multiple risk factors for developing contrast induced nephropathy (CIN), e.g. 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, e.g. 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 (e.g. tube voltage (kV) and tube potential), parameters of the administered contrast material (CM) (e.g. concentration, flow rate) and patient related factors (e.g. 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 patient's 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), e.g. 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 (33.2 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, e.g. 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Body Weight (BW) | Active comparator | Other: Contrast media administrationPatients referred for CCTA in this group receive a personalised contrast media protocol. Contrast media administration based on body weight. |
| Cardiac output (CO) | Active comparator | Other: Contrast media administrationPatients referred for CCTA in this group receive a personalised contrast media protocol. Contrast media administration based on cardiac output. |
| Lean Body weight (LBW) | Active comparator | Other: Contrast media administrationPatients referred for CCTA in this group receive a personalised contrast media protocol. Contrast media administration based on Lean Body Weight. |
| Control group | No intervention | –Patients in this group will be included retrospectively and have received the standard CM injection protocol previously used in our department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients referred for CCTA;
- Age > 18 years;
- Informed consent obtained.
Key exclusion criteria (7 listed)
- Inability to perform a breath hold for the expected scan time;
- Hemodynamic instability;
- Pregnancy;
- Renal insufficiency (defined as glomerular filtration rate (GFR) < 30 mL/min);
- Iodine allergy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast media administrationAll patients will receive contrast media with a concentration of 300 mg I/mL (Iopromide 300). The flowrate and volume will be calculated with help of the different formulas belonging to the three different arms. | Other | Body Weight (BW), Cardiac output (CO), Lean Body weight (LBW) |
Primary outcome
Image quality
Time frame: 1 year
To evaluate the performance of the individualised injection protocols in CCTA, with regard to intravascular attenuation (minimal 325 HU) and compare them with the control group (non-inferiority).
3 secondary outcomes
Objective image quality
Time frame: 1 year
subjective image quality
Time frame: 1 year
Coronary artery disease
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Background: PubMed 12754038Ambrogi V, Pompeo E, Elia S, Pistolese GR, Mineo TC. The impact of cardiovascular comorbidity on the outcome of surgery for stage I and II non-small-cell lung cancer. Eur J Cardiothorac Surg. 2003 May;23(5):811-7. doi: 10.1016/s1010-7940(03)00093-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim E Wildberger, Prof.dr. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast media administration in people with Coronary Artery Calcification and Cardiac Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03292354, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.