Breath-hold Cardiac Hybrid SPECT/CCTA

Coronary Artery Disease Clinical Trial

Official title:

Usefulness of Breath-hold Triggered SPECT-MPI in Cardiac Hybrid SPECT/CCTA Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469051
• Other study ID #: USZ-2015-0098
• Status: Completed
• Phase: N/A
• First received: May 13, 2015
• Last updated: May 10, 2016
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Breathhold SPECT-MPI
Respiratory triggered SPECT myocardial perfusion imaging
• Standard freebreathing SPECT-MPI
Clinically indicated, standard non-respiratory triggered SPECT myocardial perfusion imaging
• Coronary CT angiography
Clinically indicated coronary CT angiography serving as standard of reference

Locations

Country	Name	City	State
Switzerland	Department of Nuclear Medicine, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image quality as visually assessed on a Likert scale		1 day	No
Primary	Number of image artefacts		1 day	No