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Monocentric Registry to Investigate the Role of Platelet Function, Platelet Pharmacogenomics, Proteomics and Metabonomics in Ischemic and Non-ischemic Heart Disease (TuePIC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by University Hospital Tuebingen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417884
First Posted: August 16, 2011
Last Update Posted: January 16, 2012
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. Read our disclaimer for details.
Collaborators:
National Heart and Lung Institute
Royal Brompton & Harefield NHS Foundation Trust
Information provided by:
University Hospital Tuebingen
  Purpose
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
Cardiovascular Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Mortality [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • Cardiovascular Death [ Time Frame: 4 years ]
  • Myocardial infarction [ Time Frame: 4 years ]
  • ischemic stroke [ Time Frame: 4 years ]
  • bleeding [ Time Frame: 4 years ]
  • stent thrombosis [ Time Frame: 4 years ]

Biospecimen Retention:   Samples With DNA
Blood, salivatory

Estimated Enrollment: 3000
Study Start Date: January 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
ischemic heart disease
stable coronary artery disease, acute coronary syndromes
non-ischemic heart disease
inflammatory heart disease, heart failure (non-ischemic), valvular heart disease

  Eligibility

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01417884


Contacts
Contact: Tobias Geisler, PD Dr. med. +49 7071 29 83688 tobias.geisler@med.uni-tuebingen.de

Locations
Germany
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
Investigators
Principal Investigator: Tobias Geisler, PD Dr. med. UKT
  More Information

Responsible Party: PD Dr. med. Tobias Geisler, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01417884     History of Changes
Other Study ID Numbers: TuePIC012011
KFO 274/1-1 ( Other Grant/Funding Number: German Research Council )
First Submitted: August 12, 2011
First Posted: August 16, 2011
Last Update Posted: January 16, 2012
Last Verified: August 2011

Keywords provided by University Hospital Tuebingen:
molecular cardiology
molecular epidemiology
platelets
cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases