Infective EndocarditisNCT03626571
PET/MR Imaging In Patients With Infective Endocarditis
An observational study of Infective Endocarditis, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
PET scanning (positron emission tomography) is a well-established technique used to identify areas of interest within the body. It involves injecting a radioactive tracer which highlights abnormal areas. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Infective Endocarditis
- What is being tested?
- 18F-FDG
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2018to 28 Oct 2024
- 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 30 years and older
- All sexes
- Adult, Older adult
Study population: Patients attending the Edinburgh Heart Centre will be invited to participate. Inpatients and outpatients are eligible. Healthy volunteers will be invited to participate by local recruitment.
Who may be able to join
- Age criteria as follows:
- Native valve endocarditis >30 years
- Prosthetic valve endocarditis/device infection >50 years
- Non-infective post-operative patients >65 years
- Additional inclusion criteria:
- Completion of informed consent
- Established diagnosis of one of the conditions listed below:
- Native valve infective endocarditis; established diagnosis by Dukes criteria II. Prosthetic valve or device-related infection; established diagnosis by Dukes criteria (in the case of valves), or by microbiological, haematological and biochemical grounds (in the case of device-related infection) III. Recent implant of prosthetic valve and/or cardiac device
Who cannot join
- Inability or unwilling to give informed consent
- Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial
- Major intercurrent illness with life-expectancy <2 years
- Renal dysfunction (eGFR less than or equal to 30ml/min/1.73m2)
- Adverse reaction or hypersensitivity to 18F-FDG PET tracer
- NYHA Class IV heart failure
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- Insulin-dependent diabetes mellitus
- Patients with atrial fibrillation and poor rate control
- Contraindications to MR for patients in the groups undergoing PET/MR including any patient with suspected metal in their eyes
- Previous history of contrast allergy of adverse reactions (iodinated contrast in patients undergoing PET/CT and gadolinium in patients undergoing PET/MR)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's Medical Research Institute
Edinburgh, Midlothian, EH16 4TJ
About this study
Official title: Molecular Imaging in Infective Endocarditis Using Hybrid Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR) and Computed Tomography (PET/CT)
PET scanning (positron emission tomography) is a well-established technique used to identify areas of interest within the body. It involves injecting a radioactive tracer which highlights abnormal areas. It has recently been combined with CT (computed tomography) and MRI (magnetic resonance imaging) scanning to more accurately identify abnormalities within the heart. Infective endocarditis (infection of the heart valves or lining of the heart) and device infection (where a pacemaker device or wire becomes infected) are of particular interest in this area.
The study makes use of hybrid PET/MR scanning using a designated scanner which enables PET scanning combined with MRI scanning. PET scanning combined with CT scanning will be used instead for patients who aren't able to undergo MRI scanning. This will allow abnormal areas within the heart in these conditions to be characterised, alongside treatment regimens, in a way which hasn't been done before.
Read more
All participants will undergo PET scanning, where a radioactive tracer is injected into a vein before the scan. The radioactive substance only lasts for a short time, passed out of the body in urine. Patients with infective endocarditis involving their own heart valve will undergo an MRI scan as part of the PET scan. Patients with infective endocarditis involving a metal or prosthetic heart valve and also patients who have pacemaker infections, instead of an MRI, will have a CT scan. The reason for this is that CT is better for looking at metal and prosthetic heart valves and patients with pacemakers can't have MRI scans because the strong magnet in the scanner can affect the pacemaker. The scan will be performed twice; once before treatment and once after treatment has been established.
If successful, this imaging method will play a key role in diagnosing, quantifying and monitoring these conditions.
- Conditions
- Infective Endocarditis
- Being tested
- 18F-FDG
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGOther
Hybrid 18F-FDG PET/MR or PET/CT imaging for observational diagnostic purposes.
| Study group | Role | What they receive |
|---|---|---|
| Native valve infective endocarditis | Patients with infective endocarditis of native valves of the heart with no contraindications to MRI scanning. Receives: Other: 18F-FDG | |
| Prosthetic endocarditis | Patients with endocarditis of prosthetic heart valves or device-related infections. Receives: Other: 18F-FDG | |
| Non-infective post-operative | Patients who have recently undergone valve or device implantation with no evidence of post-operative infection. Receives: Other: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial 18F-FDG uptake
Quantification of myocardial PET tracer uptake, early and late time-points
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start1 May 2018
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies 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
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc R Dweck, MD PhD, Study director, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626571
- Sponsor's protocol ID
- AC17012
- Status last verified
- Feb 2025
- First submitted
- 8 Aug 2018
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging in Infective Endocarditis Using Hybrid Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR) and Computed Tomography (PET/CT)
- ClinicalTrials.gov ID
- NCT03626571
- Acronym / sponsor ID
- AC17012
- Conditions
- Infective Endocarditis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 13 Aug 2018 (actual)
- 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.
PET scanning (positron emission tomography) is a well-established technique used to identify areas of interest within the body. It involves injecting a radioactive tracer which highlights abnormal areas. It has recently been combined with CT (computed tomography) and MRI (magnetic resonance imaging) scanning to more accurately identify abnormalities within the heart. Infective endocarditis (infection of the heart valves or lining of the heart) and device infection (where a pacemaker device or wire becomes infected) are of particular interest in this area.
The study makes use of hybrid PET/MR scanning using a designated scanner which enables PET scanning combined with MRI scanning. PET scanning combined with CT scanning will be used instead for patients who aren't able to undergo MRI scanning. This will allow abnormal areas within the heart in these conditions to be characterised, alongside treatment regimens, in a way which hasn't been done before.
All participants will undergo PET scanning, where a radioactive tracer is injected into a vein before the scan. The radioactive substance only lasts for a short time, passed out of the body in urine. Patients with infective endocarditis involving their own heart valve will undergo an MRI scan as part of the PET scan. Patients with infective endocarditis involving a metal or prosthetic heart valve and also patients who have pacemaker infections, instead of an MRI, will have a CT scan. The reason for this is that CT is better for looking at metal and prosthetic heart valves and patients with pacemakers can't have MRI scans because the strong magnet in the scanner can affect the pacemaker. The scan will be performed twice; once before treatment and once after treatment has been established.
If successful, this imaging method will play a key role in diagnosing, quantifying and monitoring these conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Native valve infective endocarditis | – | Other: 18F-FDGPatients with infective endocarditis of native valves of the heart with no contraindications to MRI scanning. |
| Prosthetic endocarditis | – | Other: 18F-FDGPatients with endocarditis of prosthetic heart valves or device-related infections. |
| Non-infective post-operative | – | Other: 18F-FDGPatients who have recently undergone valve or device implantation with no evidence of post-operative infection. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients attending the Edinburgh Heart Centre will be invited to participate. Inpatients and outpatients are eligible. Healthy volunteers will be invited to participate by local recruitment.
Key inclusion criteria (8 listed)
- Native valve endocarditis >30 years
- Prosthetic valve endocarditis/device infection >50 years
- Non-infective post-operative patients >65 years
- Completion of informed consent
- Established diagnosis of one of the conditions listed below:
Key exclusion criteria (10 listed)
- Inability or unwilling to give informed consent
- Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial
- Major intercurrent illness with life-expectancy <2 years
- Renal dysfunction (eGFR less than or equal to 30ml/min/1.73m2)
- Adverse reaction or hypersensitivity to 18F-FDG PET tracer
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 |
|---|---|---|
| 18F-FDGHybrid 18F-FDG PET/MR or PET/CT imaging for observational diagnostic purposes. | Other | Native valve infective endocarditis, Non-infective post-operative, Prosthetic endocarditis |
Primary outcome
Myocardial 18F-FDG uptake
Time frame: 1 year
Quantification of myocardial PET tracer uptake, early and late time-points
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 14 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Marc R Dweck, MD PhD study director
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 Infective Endocarditis, 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 8 inclusion and 10 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 14 Feb 2025. 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 18F-FDG uptake (time frame: 1 year). 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 14 Feb 2025.