PET/MR Imaging In Patients With Infective Endocarditis

NCT03626571 | Completed

• 1 other identifier: AC17012
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infective Endocarditis

Outcome Measures

Primary Outcomes (1)

• Myocardial 18F-FDG uptake

  Quantification of myocardial PET tracer uptake, early and late time-points

  1 year

Study Arms (3)

Native valve infective endocarditis

Patients with infective endocarditis of native valves of the heart with no contraindications to MRI scanning.

Other: 18F-FDG

Prosthetic endocarditis

Patients with endocarditis of prosthetic heart valves or device-related infections.

Other: 18F-FDG

Non-infective post-operative

Patients who have recently undergone valve or device implantation with no evidence of post-operative infection.

Other: 18F-FDG

Interventions

18F-FDG OTHER

Hybrid 18F-FDG PET/MR or PET/CT imaging for observational diagnostic purposes.

Native valve infective endocarditis; Non-infective post-operative; Prosthetic endocarditis

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Age criteria as follows:
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Queen's Medical Research Institute

Edinburgh, Midlothian, EH16 4TJ, United Kingdom

Location

MeSH Terms

Conditions

Endocarditis

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Marc R Dweck, MD PhD

  University of Edinburgh

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 13, 2018
• Study Start: May 1, 2018
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)