Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5 participants
OBSERVATIONAL
2018-05-01
2024-10-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Native valve infective endocarditis
Patients with infective endocarditis of native valves of the heart with no contraindications to MRI scanning.
18F-FDG
Hybrid 18F-FDG PET/MR or PET/CT imaging for observational diagnostic purposes.
Prosthetic endocarditis
Patients with endocarditis of prosthetic heart valves or device-related infections.
18F-FDG
Hybrid 18F-FDG PET/MR or PET/CT imaging for observational diagnostic purposes.
Non-infective post-operative
Patients who have recently undergone valve or device implantation with no evidence of post-operative infection.
18F-FDG
Hybrid 18F-FDG PET/MR or PET/CT imaging for observational diagnostic purposes.
Interventions
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18F-FDG
Hybrid 18F-FDG PET/MR or PET/CT imaging for observational diagnostic purposes.
Eligibility Criteria
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Inclusion Criteria
* 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:
I. 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
Exclusion Criteria
* 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
* 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)
30 Years
ALL
No
Sponsors
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University of Edinburgh
OTHER
Responsible Party
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Principal Investigators
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Marc R Dweck, MD PhD
Role: STUDY_DIRECTOR
University of Edinburgh
Locations
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Queen's Medical Research Institute
Edinburgh, Midlothian, United Kingdom
Countries
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Other Identifiers
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AC17012
Identifier Type: -
Identifier Source: org_study_id
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