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CompletedNCT03626584Updated May 17, 2024

PET/MR Imaging In Patients With Cardiac Amyloidosis

An observational study in Cardiac Amyloidosis, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-17.

Sponsored by University of Edinburgh · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
33
Ages
50 Years and older
Sex
All
01

Study 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. Cardiac amyloidosis, a condition which causes thickening of heart muscle due to abnormal protein deposits, is of particular interest. There are different forms of this condition and at present samples of tissue need to be taken and analysed in order to assess these accurately, which carries risks.

The study makes use of hybrid PET/MR scanning using a designated scanner which enables PET scanning combined with MRI scanning. The investigators will use a PET tracer which is widely used in cardiac imaging as it is hoped this will enable characterisation of abnormal areas within the heart in this condition 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 and is safe, passed out of the body in urine. If successful, this imaging method will enable us to detect differences between different forms of cardiac amyloidosis in a non-invasive way, improving the diagnostic capabilities in this condition.

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Conditions studied

  • Cardiac Amyloidosis

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03

In context

Amyloidosis

491 studies on the registry are indexed under Amyloidosis; 135 are open to participants now.

This study's enrollment of 33 is below the median of 141 across 156 observational studies indexed under Amyloidosis.

Browse Amyloidosis studies →

Lead sponsor

University of Edinburgh is the lead sponsor of 393 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  • Aged over 40 years
  • Completion of informed consent
  • Established diagnosis of cardiac amyloidosis

Exclusion criteria

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
  • Patients with atrial fibrillation and poor rate control
  • Contraindications to MRI scanning
  • Previous history of contrast allergy of adverse reactions (Gadolinium-containing agents)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
33 participants (actual)
Patient registry
No

Groups and cohorts

  • Cardiac Amyloidosis Patients

    Patients with established diagnosis of cardiac amyloidosis.

    Other: 18F-NaF PET

  • Healthy Volunteers

    Healthy volunteer subjects of similar age and gender to patient cohort.

    Other: 18F-NaF PET

Interventions

  • Other18F-NaF PET

    Hybrid 18F-NaF PET/MR imaging for observational diagnostic purposes

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What researchers measure

Primary outcomes

  1. Myocardial 18F-NaF uptake

    Quantification of myocardial PET tracer uptake

    Time frame: 1 year

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Study locations

1 site
  • Queen's Medical Research Institute
    Edinburgh, Midlothian EH16 4TJ, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03626584
Lead sponsor
University of Edinburgh
Responsible party
Sponsor
First posted
Aug 13, 2018
Start date
Aug 25, 2017
Primary completion
Feb 6, 2020
Completion
Feb 6, 2020
Last update
May 17, 2024

Study contacts

Marc R Dweck, MD PhD
study director · University of Edinburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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