Clinical Validation of Computed Tomography derived Myocardial Perfusion Imaging: a Hybrid PET-CT Pilot Study II (ContRaSt II)

Recruiting

• Conditions: coronary artery disease; myocardial perfusion; 10011082

• Registration Number: NL-OMON51326
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet
all of the following criteria:
1. Patients admitted for CCS diagnosis and ischemia detection with
intermediate pre-test probability (PTP) between 15% and 85%3.
2. Patients able to give informed consent.
3. 40-80 years old.

Exclusion Criteria

Renal insufficiency with the glomerular filtration rate less the
30ml/min/kg.
• Known or suspected iodinated contrast allergy.
• Coronary Artery Bypass Grafting (CABG).
• Atrial fibrillation or other arrhythmia.
• Tachycardia.
• Pacemaker.
• BMI larger than 35 kg/m2 or weight larger than 120 kg
• Not able to hold breath for 20-30 seconds
• Possible pregnancy
•Contraindications to adenosine

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the validation of MPI-CT against the gold standard<br /><br>of 15O-water PET-CT.<br /><br>The main parameter we are going to measure is stress myocardial blood flow<br /><br>(MBF) and Myocardial Flow Reserve (MFR). Myocardial perfusion will be<br /><br>calculated quantitatively by a software as MBF in ml/g/min based on CT<br /><br>acquisitions. MBF is calculated on a per voxel basis by dividing the maximal<br /><br>slope of time-attenuation curve (TAC) by the area under the maximum arterial<br /><br>input function (AIF). The arterial input function is sampled from two regions<br /><br>of interest (ROI) placed separately in the descending aorta with every table<br /><br>position (cranial and caudal) and combined into one arterial input function.<br /><br>The MFR is calculated as a ration of stress MBF to rest MBF.<br /><br><br /><br>MBF=(Max Slope TAC)/(Maximum AIF)<br /><br><br /><br>MFR = stress MBF / rest MBF</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>