Endothelial activation during cooling and recovery in patients with primary and secondary Raynaud*s phenomenon: a feasibility/pilot study

Completed

Conditions: Scleroderma
Systemic Sclerosis
10003816
10047066

Registration Number: NL-OMON42460

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

-18 years or older
-Written informed consent
-Of sound mind and judgement;Subjects from group 2, 3 and 4 must meet the following additional criteria:
-Raynaud*s phenomenon (RP), presenting with typical signs or symptoms, objectively documented with cooling and recovery photoplethysmogram (PPG);Subjects from group 3 and 4 must meet the following additional criteria:
-Systemic Sclerosis, determined by 2013 ACR/EULAR criteria;Subjects from group 4 must meet the following additional criteria:
-Previously objectively documented with heart catheterization defined as a resting mean pulmonary artery pressure (mPAP) >= 25 mm Hg

Exclusion Criteria

-Inability to perform a venous punction
-Inabiilty to perform ppg

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are the blood and plasma levels of several<br /><br>parameters, i.e. venous lactate, bicarbonate, pH, sVCAM-1, sICAM-1, soluble<br /><br>E-selectin, PDGF-B, TGF-β, EGR-1. Also, peripheral blood mononuclear cells will<br /><br>be isolated for immunoblotting.</p><br>

Secondary Outcome Measures