All-comer registry for immunocardiology and cardiometabolic diseases Aache
- Conditions
- I20I21I22I23I24I25I46I63I64I50
- Registration Number
- DRKS00025716
- Lead Sponsor
- niversitätsklinikum Aachen – Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin (Med. Klinik I)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 400
Patients with cardiovascular risk profiles who were fasting at the time of inclusion.
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survey of endpoints as part of a follow-up (electronic, telephone) 2x every six months after discharge, then annually. Various separate, primary endpoints:<br>- All-cause mortality<br>- Triple, cardiovascular endpoint (3P MACE)<br>- cardiovascular death<br>- nonfatal myocardial infarction<br>- nonfatal stroke<br>- hospitalization for unstable angina<br>- hospitalization for coronary revascularization (PTCA of any type - with and without stent implantation and/or coronary artery bypass grafting)<br>- hospitalization for heart failure
- Secondary Outcome Measures
Name Time Method