Personalization of CM Injection Protocols in Coronary Computed Tomographic Angiography

NCT03292354 | Completed DMC

• 1 other identifier: NL59507.068.16
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Coronary Artery Calcification; Cardiac Disease

Keywords

Coronary Computed Tomography Angiography; Image Quality; Contrast Media Reduction; Personalised Injection Protocols

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year

Secondary Outcomes (3)

• Objective image quality

  1 year

• subjective image quality

  1 year

• Coronary artery disease

  1 year

Study Arms (4)

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.

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.

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.

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.

Interventions

Contrast media administration OTHER

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.

Body Weight (BW); Cardiac output (CO); Lean Body weight (LBW)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for CCTA;
• Age \> 18 years;
• Informed consent obtained.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Zuid-Limburg, 6202AZ, Netherlands

Location

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MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Joachim E Wildberger, Prof.dr.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All investigators who assess the image quality will be blinded to the assigned contrast media protocol. Only the technicians who complete the scan and injection protocol will be unblinded for the contrast media protocol chosen.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr. J.E. Wildberger

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 25, 2017
• Study Start: April 11, 2017
• Primary Completion: September 14, 2018
• Study Completion: September 14, 2018
• Last Updated: March 21, 2019

Record last verified: 2019-03

Locations

NL (1)