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:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT05181969
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for lipoprotein apheresis in accordance with regulations of the German Federal Joint Committee of physicians and medical insurance companies (G-BA; Gemeinsamer Bundesausschuss der Ärzte und Krankenkassen) are either:
* homozygous familial hypercholesterolemia or
* severe hypercholesterolemia in patients after 12 month of dietary intervention and maximal lipid-lowering drug therapy with regard on the overall risk profile of the patient or
* Lp(a) levels \> 120 nmol/L in patients with progressive cardiovascular disease after unsuccessful intervention with established methods of treatment
Mandatory for inclusion of patients for lipoprotein apheresis is a comprehensive cardiological, angiological and lipidological pre-examination.
(Deutsches Ärzteblatt 100 (2003), 1595; Deutsches Ärzteblatt 105 (2008), 1778)
Exclusion Criteria:
* Patients after transplantation
* Immunosuppressive therapy (including intake of glucocorticoids within four weeks prior to sample collection)
* uncontrolled arterial hypertension (\>180/110 mm Hg)
* epilepsy
* acute malignant and infectious diseases
* liver disease (gamma-GT \> 1.8 μmol/L×s, ALAT \> 1.5 μmol/L×s),
* severe renal dysfunction (GFR \< 30 ml/min per 1.73 m2)
* smoking
* hypersensitivity against heparin
* participation in another study
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05181969
Study Brief:
Protocol Section:
NCT05181969