Dynamic CT Myocardial Perfusion Imaging

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Other: CT-MPI and SPECT-MPI

• Registration Number: NCT02593838
• Lead Sponsor: University of Zurich

Brief Summary

This study aims at evaluating the feasibility of CT myocardial perfusion imaging in daily clinical practice and compare it to SPECT perfusion imaging in order to assess sensitivity and specifity of CT myocardial perfusion imaging compared to SPECT.

Detailed Description

If after the clinically indicated CCTA a myocardial perfusion examination is indicated, first a single ultra low dose CT scan will be performed to look for late enhancement of potentially scarred myocardium. Together with the contrast agent co-injection of the clinically indicated tracer 99mTc-Tetrofosmin will be performed for later scintigraphic perfusion evaluation. After stress perfusion imaging CT rest perfusion imaging will be performed in a similar fashion. After acquisition of CT rest perfusion images scintigraphic stress and rest image acquisition will be performed as in daily clinical routine with an additional administration of 99mTc-Tetrofosmin resting dose if necessary.

CT stress and rest perfusion will be compared to the clinically indicated and well established SPECT examination.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-11-01
• Status Verified: 2021-09
• Primary Completion: 2021-09-28
• Study Completion: 2021-09-28
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Referral for cardiac hybrid imaging with CCTA and SPECT
• Male and Female subjects 18 years of age or older,
• Written informed consent by the participant after information about the project

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Exclusion Criteria

• Contraindications for CCTA (including renal failure with a GFR <60ml/min/1.73m2, allergies to ionidated constrast agents)
• Inability to follow the examination procedure due to language barriers, mental disease, dementia etc.
• Pregnancy or breast feeding
• Known allergies to iodinated contrast agent (Visipaque ®), 99mTc-Tetrofosmin (Myoview ®), betablockers (Beloc i.v. ®) or nitrates (Isoket -Spray®)
• Hypersensitivity to adenosine
• Asthma bronchiale

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CTP and SPECT-MPI	CT-MPI and SPECT-MPI	Every patient enrolled will undergo CT-MPI and SPECT-MPI. The latter is clinically indicated,.

Primary Outcome Measures

Name	Time	Method
Validation of CT-MPI against SPECT-MPI	2 years	Sensitivity and specificity of CT-MPI to diagnose obstructive coronary artery disease using SPECTR-MPI as the standard reference

Secondary Outcome Measures

Name	Time	Method
Parameters influencing image quality of CT-MPI - Heart rate	2 years	Correlation between visually assessed image quality of CT-MPI and patient's heart rate during the scan
Parameters influencing image quality of CT-MPI - Body physique	2 years	Correlation between visually assessed image quality of CT-MPI and patient's body mass index

Trial Locations

Locations (1)

Department of Nuclear Medicine, University Hospital Zurich; 🇨🇭 Zurich, Switzerland