xSPECT-based Myocardial Perfusion Scintigraphy: Consistency of Functional Values and Feasibility of Myocardial Uptake Quantitation in Patients With Suspected Coronary Artery Disease (xSPECT MPI)

University Hospital Basel

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Diagnostic Test: 82Rb-Chloride myocardial perfusion PET with CCTA; Diagnostic Test: 99mTc-sestamibi myocardial perfusion SPECT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04583787

2020-02090, qu20Caobelli

Details and patient eligibility

About

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.).

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Patients with suspected CAD

Experimental group

Treatment:

Diagnostic Test: 99mTc-sestamibi myocardial perfusion SPECT

Diagnostic Test: 82Rb-Chloride myocardial perfusion PET with CCTA