NCT02469051

Brief Summary

This study aims at combining inspiration breath-hold myocardial perfusion SPECT with coronary CT angiography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

May 13, 2015

Last Update Submit

May 10, 2016

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

  • Image quality as visually assessed on a Likert scale

    1 day

  • Number of image artefacts

    1 day

Study Arms (1)

Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI

OTHER
Device: Breathhold SPECT-MPIDevice: Standard freebreathing SPECT-MPIDevice: Coronary CT angiography

Interventions

Breathhold SPECT-MPIDEVICE

Respiratory triggered SPECT myocardial perfusion imaging

Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI
Standard freebreathing SPECT-MPIDEVICE

Clinically indicated, standard non-respiratory triggered SPECT myocardial perfusion imaging

Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI
Coronary CT angiographyDEVICE

Clinically indicated coronary CT angiography serving as standard of reference

Also known as: CCTA
Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI

Eligibility Criteria

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

You may qualify if:

  • Referral for cardiac hybrid SPECT/CCTA
  • 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 coronary CT angiography (including renal failure with a GFR \<30ml/min/1.73m2, allergies to iodinated contrast agents)
  • Pregnancy or breast-feeding
  • Previous coronary revascularisation
  • Inability to follow the examination procedure (e.g. due to language barriers, severe mental disease etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

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

May 13, 2015

First Posted

June 11, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 11, 2016

Record last verified: 2016-05

Locations

CH(1)