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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02593838
Other study ID # USZ-2015-0393
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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