Dynamic CT Myocardial Perfusion Imaging

September 28, 2021 updated by: University of Zurich

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Department of Nuclear Medicine, University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CTP and SPECT-MPI
Every patient enrolled will undergo CT-MPI and SPECT-MPI. The latter is clinically indicated,.
Other: CT-MPI and SPECT-MPI
All patients undergo CT-MPI plus SPECT-MPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of CT-MPI against SPECT-MPI
Time Frame: 2 years
Sensitivity and specificity of CT-MPI to diagnose obstructive coronary artery disease using SPECTR-MPI as the standard reference
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Ronny R Buechel, MD, University Hospital Zurich, Department of Nuclear Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

September 28, 2021

Study Completion (Actual)

September 28, 2021

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimate)

November 1, 2015

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USZ-2015-0393

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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