Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT00273533
Eligibility Criteria:
Inclusion Criteria:
* patients with rheumatoid arthritis (4 out of 7 ARA criteria must be fulfilled to establish diagnosis) on stable background therapy for the last three months
* endothelial dysfunction (FMD \< 4%, FMD:Flow-Mediated-Dilatation)
* non-smokers
Exclusion Criteria:
* previous myocardial infarction, coronary intervention or coronary surgery
* previous treatment with statins in the last 6 months
* previous treatment with ACE-inhibitors in the last 6 months
* uncontrolled hypertension SAP/DAP \> 160/90 mmHg (SAP:Systolic Arterial Pressure, DAP:Diastolic Arterial Pressure)
* dyslipidemia (LDL-cholesterol \> 4.9 mmol)
* normal CRP \< 3 mg/l
* overweight BMI \> 35kg/m2
* anaemia (hemoglobin \< 10g/dl)
* kidney disease (creatinine \> 150 umol/l)
* insulin-dependent diabetes mellitus
* congestive heart failure (\> NYHA I)
* AV-Block\>I
* pregnancy
* angio-edema
* malignancy or chronic infection
* drug abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00273533
Study Brief:
Protocol Section:
NCT00273533