Clinical trial NCT01417884: Monocentric Registry to Investigate the Role of Platelet Function, Platelet Genetics, Proteomics and Metabonomics in Heart Disease
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Disease
Keywords: molecular cardiology
molecular epidemiology
platelets
cardiovascular disease
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: National Heart and Lung Institute
name: Royal Brompton & Harefield NHS Foundation Trust
First posted: 2011-08-16
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In-hospital patients and outpatients

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 4 years
Secondary outcomes:
measure: Cardiovascular Death
timeFrame: 4 years
measure: Myocardial infarction
timeFrame: 4 years
measure: ischemic stroke
timeFrame: 4 years
measure: bleeding
timeFrame: 4 years
measure: stent thrombosis
timeFrame: 4 years
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Medizinische Klinik und Poliklinik Tübingen, Cardiology Department, University Hospital Tübingen
state: Baden Wuerttemberg
Study officials:
affiliation: UKT
name: Tobias Geisler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: UKT, IKP Stuttgart
name: Matthias Schwab, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borst O, Munzer P, Alnaggar N, Geue S, Tegtmeyer R, Rath D, Droppa M, Seizer P, Heitmeier S, Heemskerk JWM, Jennings LK, Storey RF, Angiolillo DJ, Rocca B, Spronk H, Ten Cate H, Gawaz M, Geisler T. Inhibitory mechanisms of very low-dose rivaroxaban in non-ST-elevation myocardial infarction. Blood Adv. 2018 Mar 27;2(6):715-730. doi: 10.1182/bloodadvances.2017013573.