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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01417884
Recruitment Status : Recruiting
First Posted : August 16, 2011
Last Update Posted : May 10, 2018
National Heart and Lung Institute
Royal Brompton & Harefield NHS Foundation Trust
Information provided by (Responsible Party):
Prof. Dr. Tobias Geisler, 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.

Condition or disease
Cardiovascular Disease

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : January 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

ischemic heart disease
stable coronary artery disease, acute coronary syndromes
non-ischemic heart disease
inflammatory heart disease, heart failure (non-ischemic), valvular heart disease

Primary Outcome Measures :
  1. Mortality [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Cardiovascular Death [ Time Frame: 4 years ]
  2. Myocardial infarction [ Time Frame: 4 years ]
  3. ischemic stroke [ Time Frame: 4 years ]
  4. bleeding [ Time Frame: 4 years ]
  5. stent thrombosis [ Time Frame: 4 years ]

Biospecimen Retention:   Samples With DNA
Blood, salivatory

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In-hospital patients and outpatients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01417884

Contact: Tobias Geisler, Prof. Dr. +49 7071 29 83688

Medizinische Klinik und Poliklinik Tübingen, Cardiology Department, University Hospital Tübingen Recruiting
Tübingen, Baden Wuerttemberg, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
National Heart and Lung Institute
Royal Brompton & Harefield NHS Foundation Trust
Principal Investigator: Tobias Geisler, Prof. Dr. UKT
Principal Investigator: Matthias Schwab, Prof. Dr. UKT, IKP Stuttgart

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Dr. Tobias Geisler, Professor Dr. Tobias Geisler, University Hospital Tuebingen Identifier: NCT01417884     History of Changes
Other Study ID Numbers: TuePIC012011
KFO 274/1-1 ( Other Grant/Funding Number: German Research Council )
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Keywords provided by Prof. Dr. Tobias Geisler, University Hospital Tuebingen:
molecular cardiology
molecular epidemiology
cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases