Dynamic CT Myocardial Perfusion Imaging

Coronary Artery Disease Clinical Trial

Official title:

Diagnostic Value and Practicability of Dynamic CT Stress and Rest Myocardial Perfusion Imaging in Daily Clinical Practice - A Monocentric Prospective Diagnostic Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02593838
• Other study ID #: USZ-2015-0393
• Status: Terminated
• Phase: N/A
• Start date: September 2015
• Est. completion date: September 28, 2021

Study information

• Verified date: September 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: September 28, 2021
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Other:
• CT-MPI and SPECT-MPI
All patients undergo CT-MPI plus SPECT-MPI

Locations

Country	Name	City	State
Switzerland	Department of Nuclear Medicine, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of CT-MPI against SPECT-MPI	Sensitivity and specificity of CT-MPI to diagnose obstructive coronary artery disease using SPECTR-MPI as the standard reference	2 years
Secondary	Parameters influencing image quality of CT-MPI - Body physique	Correlation between visually assessed image quality of CT-MPI and patient's body mass index	2 years
Secondary	Parameters influencing image quality of CT-MPI - Heart rate	Correlation between visually assessed image quality of CT-MPI and patient's heart rate during the scan	2 years