ISRCTN55643149
Completed
未知
A study of using 18FDG-PET to define presence of inflammation in scleroderma myocardial involvement
Royal Free London NHSFoundation Trust0 sites20 target enrollmentStarted: March 9, 2017Last updated:
Overview
- Phase
- 未知
- Status
- Completed
- Sponsor
- Royal Free London NHSFoundation Trust
- Enrollment
- 20
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1\. Patients with Scleroderma
- •2\. Age 18 or older
- •3\. Satisfied the ACR diagnostic criteria for scleroderma (also known as systemic sclerosis)
- •4\. Suspicion of cardiac involvement from scleroderma with one of:
- •4\.1\. Left ventricular ejection fraction \< 40% on echocardiogram
- •4\.2\. Abnormal heart muscle on cardiac MRI suggestive of scleroderma involvement
- •4\.3\. Diastolic heart failure in a patient without known risk factors (must satisfy: age \<50, no known systemic hypertension, no diabetes mellitus, pulmonary arterial wedge pressure \>15 mmHg on right heart catheterisation at rest)
- •4\.4\. Persistently raised troponin (\> 2 times upper limit of normal on two occasions at least 28 days apart) without coronary artery disease
- •4\.5\. Ventricular arrythmias
- •5\. No coronary artery disease. This needs to be excluded by CT
Exclusion Criteria
- •1\. Inability to lie flat
- •2\. Pregnancy or breastfeeding
- •3\. Unwilling to undergo pregnancy test prior to study (in women of child bearing potential)
- •4\. Coronary artery disease. This needs to be excluded by CT coronary angiogram, myocardial perfusion scanning, dobutamine stress echocardiogram or conventional coronary angiogram
- •5\. Inclusion in a clinical trial involving an investigational medical product in the last 28 days
Investigators
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