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Clinical Trials/ACTRN12621000936820
ACTRN12621000936820
Not yet recruiting
未知

Assessment of subclinical right ventricular dysfunction in Systemic Sclerosis (SSc) using blood oxygen level dependent (BOLD) myocardial resonance imaging and strain echocardiography

Flinders Medical Centre0 sites88 target enrollmentJuly 16, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Flinders Medical Centre
Enrollment
88
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 16, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patient population:
  • \-Male and female aged greater than/ equal to 18 years
  • \-Confirmed diagnosis of systemic sclerosis
  • \-Screen negative for PAH based on Australian Scleroderma Interest Group (ASIG) algorithm or normal mean PAP (8\-20 mmHg; assessed by right heart catheterisation). (Screen negative implies NT\-proBNP \< 210 pg/ml and pulmonary function test demonstrating DLCO \> 70% predicted with FVC/DLCO \<1\.8\)
  • \-Normal echocardiography.
  • \-No history of cardiac disease (myocardial infarction, angina, cardiomyopathy/heart failure, pulmonary thromboembolism and significant valvular heart disease).
  • Normal healthy controls:
  • \-Male and female aged greater than/ equal to 18 years
  • \-No history of cardiac disease
  • \-Normal screening echocardiogram (post consent) which includes assessment of left and right ventricular function, diastolic function and pulmonary artery pressures

Exclusion Criteria

  • \-Inability to provide informed consent
  • \-Prior documented LV/RV systolic dysfunction.
  • \-Presence of significant coronary artery disease (\>50% stenosis).
  • \-Contraindications of CMR, including:
  • o Extreme claustrophobia
  • o Implantable cardiac devices and other contra\-indications to CMR (metal in eyes, intracranial clips)
  • o Inability to lie flat for one hour
  • \-Contraindication to gadolinium, including:
  • o Estimated Glomerular Filtration Rate (eGFR) of \<45mL/min/1\.73m2
  • \-Contraindications to adenosine, including:

Outcomes

Primary Outcomes

Not specified

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