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Dynamic CT Myocardial Perfusion Imaging

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
CT-MPI and SPECT-MPI
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Nuclear Medicine, University Hospital Zurich

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CTP and SPECT-MPI

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Parameters influencing image quality of CT-MPI - Body physique
Correlation between visually assessed image quality of CT-MPI and patient's body mass index
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

Full Information

First Posted
October 28, 2015
Last Updated
September 28, 2021
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02593838
Brief Title
Dynamic CT Myocardial Perfusion Imaging
Official Title
Diagnostic Value and Practicability of Dynamic CT Stress and Rest Myocardial Perfusion Imaging in Daily Clinical Practice - A Monocentric Prospective Diagnostic Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Recruitment problems
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 28, 2021 (Actual)
Study Completion Date
September 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CTP and SPECT-MPI
Arm Type
Other
Arm Description
Every patient enrolled will undergo CT-MPI and SPECT-MPI. The latter is clinically indicated,.
Intervention Type
Other
Intervention Name(s)
CT-MPI and SPECT-MPI
Intervention Description
All patients undergo CT-MPI plus SPECT-MPI
Primary Outcome Measure Information:
Title
Validation of CT-MPI against SPECT-MPI
Description
Sensitivity and specificity of CT-MPI to diagnose obstructive coronary artery disease using SPECTR-MPI as the standard reference
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Parameters influencing image quality of CT-MPI - Body physique
Description
Correlation between visually assessed image quality of CT-MPI and patient's body mass index
Time Frame
2 years
Title
Parameters influencing image quality of CT-MPI - Heart rate
Description
Correlation between visually assessed image quality of CT-MPI and patient's heart rate during the scan
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronny R Buechel, MD
Organizational Affiliation
University Hospital Zurich, Department of Nuclear Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nuclear Medicine, University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

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