I20 I21 I22 I23 I24 I25 I46 I63 I64 I50
Conditions
Interventions
Group 1: One-time, time-standardized blood and stool sample collection from inpatients after study inclusion and storage of biomaterials in the RWTH centralized Biomaterial Bank (in short: RWTH cBMB)
collection of demographic and medical data, questionnaires and risk scores
telephone follow-up: collection of cardiovascular endpoints as part of a follow-up (electronically, by telephone) 2x every six months after discharge, then annually.
Sponsors
Universitätsklinikum Aachen – Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin (Med. Klinik I)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with cardiovascular risk profiles who were fasting at the time of inclusion.
Exclusion criteria
Exclusion criteria: 1. glucocorticoid/cortisone use (oral, intravenous - Not: topical, inhalation) and/or other immunosuppressive medication (except colchicine). 2. condition following solid organ transplantation or being on a waiting list for solid organ transplantation 3. active/chronic or recently treated malignant disease within the last 5 years - Not: non-metastatic basal cell carcinoma of the skin 4. acute/active inflammatory disease of infectious and non-infectious nature - e.g. infectious: bacterial disease (e.g. bacterial urinary tract infection, tuberculosis), viral disease (e.g. HIV/AIDS, viral hepatitis, COVID-19), fungal disease, parasitic disease - e.g. non-infectious: sarcoidosis and other granulomatous diseases 5. acute episode of inflammatory bowel disease (Crohn's disease, ulcerative colitis) within the last 24 months 6. autoimmune diseases - Not: diabetes mellitus, type 1 and/or Hashimoto's thyroiditis 7. acute or chronic disease of the hematopoietic system (including lymphoproliferative disorders) 8. final stage liver disease 9. active drug abuse - Not: alcohol abuse 10. pregnancy and/or lactation 11. persons who are institutionalized by court or administrative order 12. persons who are in a dependent or employment relationship with the investigator 13. simultaneous participation in another clinical trial 14. patients who are unwilling or unable to understand and comply with the instructions of the personnel 15. taking an investigational drug 30 days prior to the start of the project 16. patients who are incapable of giving consent and/or are unable to understand the nature, significance and scope of the research project and to give their consent in writing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survey of endpoints as part of a follow-up (electronic, telephone) 2x every six months after discharge, then annually. Various separate, primary endpoints: - All-cause mortality - Triple, cardiovascular endpoint (3P MACE) - cardiovascular death - nonfatal myocardial infarction - nonfatal stroke - hospitalization for unstable angina - hospitalization for coronary revascularization (PTCA of any type - with and without stent implantation and/or coronary artery bypass grafting) - hospitalization for heart failure | — |
Countries
Germany
Contacts
Public ContactFlorian Kahles
Universitätsklinikum Aachen – Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin (Med. Klinik I)
Outcome results
None listed