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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51073

Enrollment

Registered

2021-02-22

Start date

2021-06-29

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease myocardial perfusion

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results