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

Cardiovascular Disease Clinical Trial

— TuePIC  

Official title:

Development of a Prospective Cardiovascular Patient Cohort and Biobank and Provision of Genomic Analyses With Focus on Platelet Function and Platelet Mediated Inflammatory Processes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01417884
• Other study ID #: TuePIC012011
• Secondary ID: KFO 274/1-1
• Status: Recruiting
• Start date: January 2012
• Est. completion date: December 2025

Study information

• Verified date: October 2018
• Source: University Hospital Tuebingen
• Contact: Tobias Geisler, Prof. Dr.
• Phone: +49 7071 29 82712
• Email: tobias.geisler[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2025
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
Germany	Medizinische Klinik und Poliklinik Tübingen, Cardiology Department, University Hospital Tübingen	Tübingen	Baden Wuerttemberg

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Tuebingen	National Heart and Lung Institute, Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		4 years
Secondary	Cardiovascular Death		4 years
Secondary	Myocardial infarction		4 years
Secondary	ischemic stroke		4 years
Secondary	bleeding		4 years
Secondary	stent thrombosis		4 years