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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51326
Enrollment
20
Registered
2022-02-10
Start date
2022-05-18
Completion date
Unknown
Last updated
2024-04-15

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

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

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. • 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

Design outcomes

Primary

MeasureTime frame
The main study endpoint is the validation of MPI-CT against the gold standard of 15O-water PET-CT. The main parameter we are going to measure is stress myocardial blood flow (MBF) and Myocardial Flow Reserve (MFR). 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. The MFR is calculated as a ration of stress MBF to rest MBF. MBF=(Max Slope TAC)/(Maximum AIF) MFR = stress MBF / rest MBF

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)