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

NCT ID: NCT04583787

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-07

Study Completion Date

2024-05-28

Brief Summary

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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.).

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with suspected CAD

Group Type EXPERIMENTAL

99mTc-sestamibi myocardial perfusion SPECT

Intervention Type DIAGNOSTIC_TEST

82Rb-PET/CT with CT based coronary angiography (CCTA) as part of clinical care at Day 1

82Rb-Chloride myocardial perfusion PET with CCTA

Intervention Type DIAGNOSTIC_TEST

stress-rest 99mTc-sestamibi myocardial perfusion SPECT, performed subsequent to 99mTc-sestamibi myocardial perfusion SPECT at Day 2

Interventions

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99mTc-sestamibi myocardial perfusion SPECT

82Rb-PET/CT with CT based coronary angiography (CCTA) as part of clinical care at Day 1

Intervention Type DIAGNOSTIC_TEST

82Rb-Chloride myocardial perfusion PET with CCTA

stress-rest 99mTc-sestamibi myocardial perfusion SPECT, performed subsequent to 99mTc-sestamibi myocardial perfusion SPECT at Day 2

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siemens Corporation, Corporate Technology

INDUSTRY

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Federico Caobelli, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Clinic of Radiology & Nuclear Medicine

Locations

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Clinic of Radiology & Nuclear Medicine, University Hospital of Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2020-02090, qu20Caobelli

Identifier Type: -

Identifier Source: org_study_id

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