Myocardial Inflammation
Conditions
Brief summary
Primary myocardial involvement is common in scleroderma, effected to pericardium, vascular, conducting defect and especially myocardium. Cardiac MRI is widely used for assessment of cardiac involvement in scleroderma, both structural and functional pathology. Cardiac MRI has a diagnostic accuracy of 85% for the detection of myocardial inflammation. Nowadays, the treatment of myocardial inflammation in scleroderma is uncertain. The investigator's study aims to define the cardiac outcome after moderate dose steroid therapy in the patients who have myocardial inflammation detection by cardiac MRI.
Interventions
DRUGPrednisolone and taper
Prednisolone 30 mg/d and taper 5-10 mg per 2 weeks until off at week 24.
Sponsors
Khon Kaen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Moderate dose steroid therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• The adult scleroderma patients who were defined as having myocardial inflammation by cardiac MRI.
Exclusion criteria
* Current infection that needs systemic antibiotic therapy * Active viral hepatitis B or C * Uncontrolled diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changing of degree of myocarditis evaluated by cardiac MRI after treatment compare to baseline | 24 weeks | Myocarditis is defined as inflammatory disease of the myocardium according to the cardiac MRI Lake Louise criteria at least 2 of the following criteria: 1. Regional or global myocardial signal intensity increased in the T2-weighted images; 2. Increased global myocardial early enhancement ratio between the myocardium and skeletal muscle in the gadolinium-enhanced T1-weighted images; and, 3. At least 1 focal lesion with nonischemic regional distribution in the inversion-recovery-prepared, gadolinium-enhanced, T1-weighted images (delayed enhancement). Response to treatment is defined as any reducing of degree of myocarditis without any progression of myocardial fibrosis or scarring when compared to the cardiac MRI baseline |
Countries
Thailand
Outcome results
None listed