NCT02593838

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2021

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

6.1 years

First QC Date

October 28, 2015

Last Update Submit

September 28, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Parameters influencing image quality of CT-MPI - Body physique

    2 years

  • Parameters influencing image quality of CT-MPI - Heart rate

    2 years

Study Arms (1)

CTP and SPECT-MPI

OTHER

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

Other: CT-MPI and SPECT-MPI

Interventions

All patients undergo CT-MPI plus SPECT-MPI

CTP and SPECT-MPI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ronny R Buechel, MD

    University Hospital Zurich, Department of Nuclear Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2015

First Posted

November 2, 2015

Study Start

September 1, 2015

Primary Completion

September 28, 2021

Study Completion

September 28, 2021

Last Updated

October 6, 2021

Record last verified: 2021-09

Locations