Microangiopathy after autologous hematopoietic stem cell transplantation in systemic sclerosis

Microangiopathy after autologous hematopoietic stem cell transplantation in systemic sclerosis - MICAST

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46923

Enrollment

100

Registered

2018-03-20

Start date

2017-01-23

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

scleroderma systemic sclerosis

Interventions

microangiopathy

nailfold capillaromicroscopy

stem cell transplantation

systemic sclerosis

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Age above 18 2. Systemic sclerosis meeting the American Rheumatism Association criteria (1980) 3. Severe systemic sclerosis with: a. disease duration 15 and respiratory involvement b. disease duration 20 and ESR > 25 mm/1st hour and/or Hb

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
Microangiopathy will be assessed by NCM. NCM pattern will be classified as early, active or late. Capillary density, number of giants and number of micro-haemorrhages will be observed. Additionally, PRINCE, MES scores and mNEMO scores will be calculated.	—

Secondary

Measure	Time frame
To assess clinical response, a physician global assessment for treatment response will be performed per organ system, the Medsger SSc severity score will be assessed, and the HAQ-DI will be calculated.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)