Myocardial Blood Flow by 15O Water PET | NCT01805193

Studies
Myocardial Blood Flow by 15O Water PET

NCT01805193

Sponsor

University of Edinburgh

Status

Completed

Last Update Posted

Feb 22, 2019Actual

Enrollment

22Actual

Phase

Not provided

Conditions

Coronary Heart Disease

Interventions

Computed tomography myocardial perfusion imaging
Oxygen 15 labelled water positron emission tomography

Countries

United Kingdom

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

Feb 2019

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

Dec 2012

Primary Completion Date

Jun 2014Actual

Completion Date

Jan 2019Actual

First Submitted Date

Feb 4, 2013

First Submission Date that Met QC Criteria

Mar 4, 2013

First Posted Date

Mar 6, 2013Estimated

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

Feb 21, 2019

Last Update Posted Date

Feb 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Description Module

Brief Summary

Coronary heart disease is a very common condition caused by narrowings in the blood vessel supplying the heart. the investigators are studying new tests to diagnose heart disease. In this study the investigators plan to investigate a special scan called a PET/CT (Positron emission tomography/computed tomography) and a new type of CT (Computed tomography) scan to tell us about the flow of blood to the heart muscle.

Detailed Description

Participants will undergo PET/CT with oxygen-15 labelled water and computed tomography myocardial perfusion imaging.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Suspected coronary heart disease			Other: Computed tomography myocardial perfusion imaging Other: Oxygen 15 labelled water positron emission tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Computed tomography myocardial perfusion imaging	Other		Suspected coronary heart disease
Oxygen 15 labelled water positron emission tomography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Myocardial blood flow	Myocardial blood flow ( ml/g/min) measured by oxygen-15 water positron emission tomography	1 month

Secondary Outcomes

Measure	Description	Time Frame
Fractional flow reserve	Fractional flow reserve measured during invasive coronary angiography	1 month
Myocardial perfusion	Myocardial perfusion measured as hypoperfusion on adenosine computed tomography myocardial perfusion imaging

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

suspected coronary artery disease

Exclusion Criteria:

inability or unwillingness to undergo CT or PET imaging
renal failure (serum creatinine >200 um/L or eGFR <30 ml/min)
hepatic failure
allergy to iodinated contrast
pregnancy
contraindication to adenosine
inability to give informed consent
atrial fibrillation with a fast ventricular rate (>70 beats per minute)

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

Outpatients with suspected coronary heart disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Newby, PhD DM	University of Edinburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Imaging Centre		Edinburgh	Scotland		United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided