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Physiological Stress 15O-H2O Total-body PET/CT protocol

Physiological Stress 15O-H2O Total-body PET/CT protocol - Physiological Stress Total-body PET/CT

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53400
Enrollment
20
Registered
2023-02-27
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-06-15

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

Nucleaire Geneeskunde en Moleculaire Beeldvorming
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: o Healthy subjects: * Aged above 40 years * Male or female * Good general health * Height 1.60 m - 1.85 m * BMI 20-25 kg/m2 * Informed consent signed o Patients suspected or known with Coronary Artery Disease: * Aged above 40 years * Male or female * Height 1.60 m - 1.85 m * Diagnosed or suspected with Coronary Artery Disease * Informed consent signed

Exclusion criteria

Exclusion criteria: o 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 * Expressed willing to not continue with the participation * Pregnancy or breastfeeding * Claustrophobia * Not able to cycle o Patients suspected or known with Coronary Artery Disease: * 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 * Clinical active bronchospasm * Chronic obstructive pulmonary disease or asthma * Expressed willing to not continue with the participation * Pregnancy or breastfeeding * Claustrophobia * Not able to cycle

Design outcomes

Primary

MeasureTime frame
The main parameters to measure are regional and global MBF and CFR during rest and stress with the different proposed stressors: adenosine, breath-holding manoeuvre, Valsalva manoeuvre and bicycle exercise. MBF will be calculated by a research dedicated software (Carimas) in ml/g/min based on 15O-H2O 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 manoeuvre, Valsalva manoeuvre and bicycle exercise as stress myocardial perfusion test during 15O-H2O Total-body PET/CT. Adenosine stress serves as the reference method.3330 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 different proposed stressors: breath-holding manoeuvre, Valsalva manoeuvre and bicycle exercise): • CBF is the blood volume that flows per unit per mass per unit in time in brain tissue calculated by a software (PMOD) and expressed in ml/g/min based on 15O-H2O 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 15O-H2O Total-body 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) · Data processed: Jun 21, 2026