Monocentric Registry to Investigate the Role of Platelet Function, Platelet Genetics, Proteomics and Metabonomics in Heart Disease

Recruiting

• Conditions: Cardiovascular Disease

• Registration Number: NCT01417884
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

Molecular targets on platelets are pivotal for the development of new pharmacological substrates for platelet inhibition and to better understand the impact of platelet-mediated inflammatory processes for the progression of heart disease, such as coronary heart disease and chronic heart failure. Previous investigations on the thienopyridine Clopidogrel have underlined the importance of combined risk factor analysis. Thus, clopidogrel´s prognostic efficacy relies on the combination of genetic factors (mainly polymorphisms of CYP2C19 encoding genes) and non-genetic factors, such as age, diabetes mellitus or concomitant drugs. Therefore, a prospective patient cohort with exact phenotypic characterisation according to standardized protocols is necessary to enable the examination of the clinical relevance of potential molecular targets. A supplementary provision of high quality bio-material enables the systematic examination of new promising platelet-biomarkers in cardiovascular disease, which already have produced significant results on experimental animal and/or cell biologic models. Primary objective of the central project is to establish a prospective cardiological cohort in the setting of a Cardiovascular Clinical Research Unit (CCRU) with an affiliated Biobank and thus to review the clinical significance of potential targets deriving from individual subprojects within the research group (German Research Council KFO 274/1-1) to safeguard a translational approach.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Study Start: 2012-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-15
• Primary Completion: 2020-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

1. Patients with ischemic and non-ischemic heart disease
2. informed consent by patients or relatives in case of missing capacity to consent due to health status

Exclusion Criteria

1. Patients <18 years
2. missing informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	4 years

Secondary Outcome Measures

Name	Time	Method
bleeding	4 years
stent thrombosis	4 years
ischemic stroke	4 years
Myocardial infarction	4 years
Cardiovascular Death	4 years

Trial Locations

Locations (1)

Medizinische Klinik und Poliklinik Tübingen, Cardiology Department, University Hospital Tübingen; 🇩🇪 Tübingen, Baden Wuerttemberg, Germany