NCT01805193

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

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

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

1.5 years

First QC Date

February 4, 2013

Last Update Submit

February 21, 2019

Conditions

Coronary Heart Disease

Keywords

Coronary heart diseasecomputed tomography myocardial perfusionpositron emission tomographyoxygen 15 labelled watermyocardial perfusionmyocardial blood flow

Outcome Measures

Primary Outcomes (1)

  • Myocardial blood flow

    Myocardial blood flow ( ml/g/min) measured by oxygen-15 water positron emission tomography

    1 month

Secondary Outcomes (2)

  • Fractional flow reserve

    1 month

  • Myocardial perfusion

    1 month

Study Arms (1)

Suspected coronary heart disease

Other: Computed tomography myocardial perfusion imagingOther: Oxygen 15 labelled water positron emission tomography

Interventions

Computed tomography myocardial perfusion imagingOTHER
Suspected coronary heart disease
Oxygen 15 labelled water positron emission tomographyOTHER
Suspected coronary heart disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients with suspected coronary heart disease

You may qualify if:

  • suspected coronary artery disease

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Imaging Centre

Edinburgh, Scotland, United Kingdom

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • David Newby, PhD DM

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2013

First Posted

March 6, 2013

Study Start

December 1, 2012

Primary Completion

June 1, 2014

Study Completion

January 1, 2019

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations

GB(1)