Myocardial Inflammation Clinical Trial
Official title:
Outcome of Myocardial Inflammation After Steroid Therapy in Thai Systemic Sclerosis Patients: an Open Label Study
NCT number | NCT03607071 |
Other study ID # | SSc-KKU |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 15, 2018 |
Est. completion date | June 30, 2019 |
Verified date | September 2020 |
Source | Khon Kaen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Department of Medicine, Faculty of Medicine, Khon Kaen University | Khon Kaen |
Lead Sponsor | Collaborator |
---|---|
Khon Kaen University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changing of degree of myocarditis evaluated by cardiac MRI after treatment compare to baseline | Myocarditis is defined as inflammatory disease of the myocardium according to the cardiac MRI Lake Louise criteria at least 2 of the following criteria: Regional or global myocardial signal intensity increased in the T2-weighted images; Increased global myocardial early enhancement ratio between the myocardium and skeletal muscle in the gadolinium-enhanced T1-weighted images; and, 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 |
24 weeks |
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