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Physiological Stress [13N]NH3 Total-body PET/CT protocol

Physiological Stress [13N]NH3 Total-body PET/CT protocol - Physiological Stress [13N]NH3 TB PET/CT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57651
Enrollment
20
Registered
2025-06-06
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-09-08

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

University Medical Center Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: o Healthy subjects: * Age above 40 years * Gender: 50% women, 50% men * Good general health * BMI

Exclusion criteria

Exclusion criteria: Healthy subjects: * Clinical history of diabetes, hypertension, dyslipidemia * History of cardiac disease * Family history of Coronary Artery Disease * Active or short history of cigarette smoking * Inability or unwillingness to give informed consent * Known hypersensitivity to adenosine * Clinical active bronchospasm * Chronic obstructive pulmonary disease or asthma * Chronic kidney disease * Unwillingness to continue with the protocol * Pregnancy or breastfeeding * Claustrophobia o Patients recently diagnosed with CAD: * Known hypersensitivity to adenosine * Bundle branch block * Presence or temporal or definitive pacemaker * Presence of heart valve prosthesis, shoulder prosthesis, prosthetic reconstruction of the chest wall, or other prosthetic devices within the field of view * History of cardiovascular intervention, percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG) * Clinical active bronchospasm * Chronic obstructive pulmonary disease or asthma * Unwillingness to continue with the protocol * Pregnancy or breastfeeding * Claustrophobia

Design outcomes

Primary

MeasureTime frame
The main parameters to measure are regional and global MBF and CFR during rest and stress with the proposed stressor: adenosine, and breath-holding maneuver. MBF will be calculated by dedicated software (MBF Siemens) in ml/g/min based on [13N]NH3 Total-body PET/CT acquisitions. CFR will be calculated as the ratio of stress MBF and rest MBF. CFR=(stress MBF)/(rest MBF) Data of myocardial perfusion will be analysed to address the feasibility of breath-holding maneuver as a stressor for myocardial perfusion test during [13N]NH3 Total-body PET/CT. Adenosine stress serves as the reference method: MBF stress above 1.85 mL/min/g and CFR above 2.0.(27) Final values in these parameters will be reported for all the cohorts in a descriptive manner: -Normally distributed quantitative variables will be presented with mean, standard deviation and 95% confidence interval. -Non-normally distributed data will be presented with median and interquartile range.

Secondary

MeasureTime frame
The secondary parameters will be measured by rest and stress phases (with adenosine stress and with the proposed stressor: breath-holding maneuver): • Left ventricular volumes are automatically calculated by a dedicated software (MBF Siemens) from ECG-gated total-body PET/CT reconstruction. End-systolic volume (ESV) is the minimum point of the time-volume curve. End-diastolic volume (EDV) is the maximum point of the time-volume curve from the acquisition. Left ventricular ejection fraction is calculated automatically as follows: %LVEF=(EDV - ESV)/EDV x 100. • CBF is the blood volume that flows per unit per mass per unit in time in brain tissue calculated by software (PMOD) and expressed in ml/g/min based on [13N]NH3 Total-body PET/CT acquisitions. • RBF and SBF refer to the blood volume that flows to the kidneys and to the spleen respectively. These measurements are expressed in ml/g/min and will be calculated using dedicated software (PMOD) based on [13N]NH3 PET/CT dynamic images. Quantitative descriptive analysis will be performed to report the performance of CBF, RBF, and SBF in rest and during physiological and adenosine stress.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)