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Clinical Trials/ISRCTN55643149
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

Sponsor
Royal Free London NHSFoundation Trust

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