Breath-hold Cardiac Hybrid SPECT/CCTA | NCT02469051

Studies
Breath-hold Cardiac Hybrid SPECT/CCTA

NCT02469051

Sponsor

University of Zurich

Status

Completed

Last Update Posted

May 11, 2016Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Coronary Artery Disease

Interventions

Breathhold SPECT-MPI
Standard freebreathing SPECT-MPI
Coronary CT angiography

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

May 13, 2015

First Submission Date that Met QC Criteria

Jun 8, 2015

First Posted Date

Jun 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2016

Last Update Posted Date

May 11, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI	Other		Device: Breathhold SPECT-MPI Device: Standard freebreathing SPECT-MPI Device: Coronary CT angiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breathhold SPECT-MPI	Device	Respiratory triggered SPECT myocardial perfusion imaging	Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Image quality as visually assessed on a Likert scale		1 day
Number of image artefacts		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nuclear Medicine, University Hospital Zurich		Zurich	Canton of Zurich	8091	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided