Clinical trial NCT04583787: xSPECT-based Myocardial Perfusion Scintigraphy: Consistency of Functional Values and Feasibility of Myocardial Uptake Quantitation in Patients With Suspected Coronary Artery Disease
Official title: xSPECT-based Myocardial Perfusion Scintigraphy: Consistency of Functional Values and Feasibility of Myocardial Uptake Quantitation in Patients With Suspected Coronary Artery Disease (xSPECT MPI Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: 82Rb-Chloride myocardial perfusion PET with CTCA
99mTc-sestamibi myocardial perfusion SPECT
Myocardial perfusion SPECT
Absolute myocardial blood flow (MBF)
Myocardial Standardized uptake value (SUV)
CT coronary angiography (CTCA)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Siemens Corporation, Corporate Technology
First posted: 2020-10-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will receive a 82Rb-PET/CT with CT based coronary angiography (CCTA) as part of clinical care. Subsequently, patients will undergo a stress-rest 99mTc-sestamibi myocardial perfusion SPECT, which will be evaluated both qualitatively and quantitatively
Primary purpose: DIAGNOSTIC

Brief summary: This study is to evaluate the feasibility of myocardial Standardized Uptake Volume (SUV) assessment by means of X- (Single photon emission tomography) SPECT/Computed tomography (CT), to assess normal reference value under rest and stress in a homogeneous population without Coronary Artery Disease (CAD) and to assess the variation of absolute quantitative SUV measurements under rest and stress. The values will be evaluated in comparison with perfusion Positron Emission Tomography (PET)/CT (using 82Rb as perfusion tracer) and CT coronary angiography (CTCA) with contrast medium.).


Eligibility criteria: Inclusion Criteria:

* Referral to non-invasive nuclear ischemia test as part of clinical care
* Suspected coronary artery disease based on clinical symptoms
* Informed Consent as documented by signature

Exclusion Criteria:

* Pregnancy
* Allergy against adenosine
* Allergy against iodinated contrast medium
* Recent myocardial infarction (\<1 month)
* Previous history of coronary revascularization
* Severe asthma
* Thyroid hyperfunction
* atrioventricular block (AV) Block \> I grade
* Arrhythmic cardiopathy
* Weight \>101 Kg.
* Acute or chronic renal impairment defined as Serum-Creatinine: above 1.5x upper limit of normal (ULN) and/or glomerular filtration rate (GFR) \< 30 ml/min
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* Claustrophobia
* Intake of caffeine \<24 Hours before the first day of examination
* Enrolment into another study using ionizing radiation within the previous 12 months.

Primary outcomes:
measure: Absolute flow quantification (assessed by PET/CT)
timeFrame: 60 minutes at Day 1
measure: presence of significant coronary stenoses (CTCA)
timeFrame: 120 minutes at Day 2
Secondary outcomes:
measure: Determination of uptake patterns that are suggestive for CAD
timeFrame: one point assessment after interventions at day 2
measure: Quantitative 99mTC-sestamibi uptake values of the whole myocardium
timeFrame: one point assessment after interventions at day 2
measure: Comparison of PET/CT, standard Myocardial perfusion SPECT (MPS) and new quantitative 99mTc-sestamibi xSPECT/quantitative computerized tomography (QCT) in the same patient
timeFrame: one point assessment after interventions at day 2
measure: Interobserver variability of all imaging modalities
timeFrame: one point assessment after interventions at day 2
measure: Interobserver variability of qualitative and quantitative assessments
timeFrame: one point assessment after interventions at day 2
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clinic of Radiology & Nuclear Medicine, University Hospital of Basel
Study officials:
affiliation: Clinic of Radiology & Nuclear Medicine
name: Federico Caobelli, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: