Dynamic CT Myocardial Perfusion Imaging

Sponsor

University of Zurich (Other)

Overall Status

Terminated

CT.gov ID

NCT02593838

Collaborator

(none)

Enrollment

Location

Arm

72.9

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Other: CT-MPI and SPECT-MPI	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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 Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Sep 28, 2021

Actual Study Completion Date :

Sep 28, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nuclear Medicine, University Hospital Zurich	Zurich		Switzerland	8091

Sponsors and Collaborators

University of Zurich

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Zurich

ClinicalTrials.gov Identifier:

NCT02593838

Other Study ID Numbers:

USZ-2015-0393

First Posted:

Nov 1, 2015

Last Update Posted:

Oct 6, 2021

Last Verified:

Sep 1, 2021

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Oct 6, 2021