Coronary Heart DiseaseNCT01805193
Myocardial Blood Flow by 15O Water PET
An observational study of Coronary Heart Disease, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Computed tomography myocardial perfusion imaging and Oxygen 15 labelled water positron emission tomography
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2012to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients with suspected coronary heart disease
Who may be able to join
- suspected coronary artery disease
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Imaging Centre
Edinburgh, Scotland
About this study
Official title: 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.
Read the detailed description
Participants will undergo PET/CT with oxygen-15 labelled water and computed tomography myocardial perfusion imaging.
- Conditions
- Coronary Heart Disease
- Being tested
- Computed tomography myocardial perfusion imaging, Oxygen 15 labelled water positron emission tomography
- Keywords
- Coronary heart disease, computed tomography myocardial perfusion, positron emission tomography, oxygen 15 labelled water, myocardial perfusion, myocardial blood flow
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography myocardial perfusion imagingOther
Oxygen 15 labelled water positron emission tomographyOther
| Study group | Role | What they receive |
|---|---|---|
| Suspected coronary heart disease | Not described Receives: Other: Computed tomography myocardial perfusion imaging; Other: Oxygen 15 labelled water positron emission tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial blood flow
Myocardial blood flow ( ml/g/min) measured by oxygen-15 water positron emission tomography
Measured: 1 month
Secondary outcomes (2)
Fractional flow reserve
Fractional flow reserve measured during invasive coronary angiography
Measured: 1 month
Myocardial perfusion
Myocardial perfusion measured as hypoperfusion on adenosine computed tomography myocardial perfusion imaging
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2014
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Newby, PhD DM, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805193
- Sponsor's protocol ID
- 12/SS/0078
- Status last verified
- Feb 2019
- First submitted
- 4 Feb 2013
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Computed Tomography Myocardial Perfusion Imaging Using Quantification of Myocardial Blood Flow by Positron Emission Tomography With 15O-water
- ClinicalTrials.gov ID
- NCT01805193
- Acronym / sponsor ID
- 12/SS/0078
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary heart disease, computed tomography myocardial perfusion, positron emission tomography, oxygen 15 labelled water, myocardial perfusion, myocardial blood flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 6 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected coronary heart disease | – | Other: Computed tomography myocardial perfusion imaging, Other: Oxygen 15 labelled water positron emission tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with suspected coronary heart disease
Key inclusion criteria (1 listed)
- suspected coronary artery disease
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomography myocardial perfusion imaging | Other | Suspected coronary heart disease |
| Oxygen 15 labelled water positron emission tomography | Other | Suspected coronary heart disease |
Primary outcome
Myocardial blood flow
Time frame: 1 month
Myocardial blood flow ( ml/g/min) measured by oxygen-15 water positron emission tomography
2 secondary outcomes
Fractional flow reserve
Time frame: 1 month
Myocardial perfusion
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Newby, PhD DM principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial blood flow (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.