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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01417884
Acronym
TuePIC
Enrollment
3000
Registered
2011-08-16
Start date
2012-01-31
Completion date
2025-12-31
Last updated
2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

molecular cardiology, molecular epidemiology, platelets, cardiovascular disease

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.

Interventions

None listed

Sponsors

National Heart and Lung Institute
CollaboratorOTHER
Royal Brompton & Harefield NHS Foundation Trust
CollaboratorOTHER
University Hospital Tuebingen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mortality4 years

Secondary

MeasureTime frame
Cardiovascular Death4 years
Myocardial infarction4 years
ischemic stroke4 years
bleeding4 years
stent thrombosis4 years

Countries

Germany

Contacts

Primary ContactTobias Geisler, Prof. Dr.
tobias.geisler@med.uni-tuebingen.de+49 7071 29 82712

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026