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PET/MR Imaging In Patients With Infective Endocarditis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626571
Recruitment Status : Unknown
Verified August 2018 by University of Edinburgh.
Recruitment status was:  Recruiting
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

Study Description
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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.


Condition or disease Intervention/treatment
Infective Endocarditis Other: 18F-FDG

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Imaging in Infective Endocarditis Using Hybrid Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR) and Computed Tomography (PET/CT)
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Native valve infective endocarditis
Patients with infective endocarditis of native valves of the heart with no contraindications to MRI scanning.
 Other: 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.
 Other: 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.
 Other: 18F-FDG
Hybrid 18F-FDG PET/MR or PET/CT imaging for observational diagnostic purposes.


Outcome Measures
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Primary Outcome Measures :
  1. Myocardial 18F-FDG uptake [ Time Frame: 1 year ]
    Quantification of myocardial PET tracer uptake, early and late time-points


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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:

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:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626571


Contacts
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Contact: Nicholas B Spath, MBBS BSc 0131 242 6515 nick.spath@ed.ac.uk
Contact: Sponsor Representative 0131 242 3330 enquiries@accord.scot

Locations
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United Kingdom
Queen's Medical Research Institute Recruiting
Edinburgh, Midlothian, United Kingdom, EH16 4TJ
Contact: Nicholas B Spath, MBBS BSc    0131 242 6515    nick.spath@ed.ac.uk   
Sponsors and Collaborators
University of Edinburgh
Investigators
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Study Director: Marc R Dweck, MD PhD University of Edinburgh
More Information
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03626571    
Other Study ID Numbers: AC17012
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endocarditis, Bacterial
Endocarditis
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Cardiovascular Infections
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action