Myocardial Blood Flow by 15O Water PET

February 21, 2019 updated by: University of Edinburgh

Validation of Computed Tomography Myocardial Perfusion Imaging Using Quantification of Myocardial Blood Flow by Positron Emission Tomography With 15O-water

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Edinburgh, Scotland, United Kingdom
        • Clinical Research Imaging Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatients with suspected coronary heart disease

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Suspected coronary heart disease
Other: Computed tomography myocardial perfusion imaging
Other: Oxygen 15 labelled water positron emission tomography

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Investigators

  • Principal Investigator: David Newby, PhD DM, University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

March 4, 2013

First Posted (Estimate)

March 6, 2013

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/SS/0078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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