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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by University Hospital Tuebingen
Sponsor:
Collaborators:
National Heart and Lung Institute
Royal Brompton & Harefield NHS Foundation Trust
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01417884
First received: August 12, 2011
Last updated: January 13, 2012
Last verified: August 2011
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular Death [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Myocardial infarction [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • ischemic stroke [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • bleeding [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • stent thrombosis [ Time Frame: 4 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 12, 2011
Last Updated: January 13, 2012
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014