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RecruitingNCT01417884TuePICUpdated Oct 15, 2018

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

An observational study in Cardiovascular Disease, sponsored by University Hospital Tuebingen. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-15.

Sponsored by University Hospital Tuebingen · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2020, 5 years 10 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiovascular Disease

Keywords

  • molecular cardiology
  • molecular epidemiology
  • platelets
  • cardiovascular disease
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  1. Patients \<18 years
  2. missing informed consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Biospecimen retention
Samples with dna

Groups and 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

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What researchers measure

Primary outcomes

  1. Mortality

    Time frame: 4 years

Secondary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Medizinische Klinik und Poliklinik Tübingen, Cardiology Department, University Hospital Tübingen
    Tübingen, Baden Wuerttemberg 72076, Germany
    Recruiting
08

References and documents

Publications

  • 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. PubMed 29588304 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01417884
Lead sponsor
University Hospital Tuebingen
Collaborators
National Heart and Lung Institute, Royal Brompton & Harefield NHS Foundation Trust
Responsible party
Prof. Dr. Tobias Geisler (Deputy Director, University Hospital Tuebingen) — Principal investigator
First posted
Aug 16, 2011
Start date
Jan 2012
Primary completion
Dec 2020 (estimated)
Completion
Dec 2025 (estimated)
Last update
Oct 15, 2018

Study contacts

Tobias Geisler, Prof. Dr.
Contact
tobias.geisler@med.uni-tuebingen.de
+49 7071 29 82712
Tobias Geisler, Prof. Dr.
principal investigator · UKT
Matthias Schwab, Prof. Dr.
principal investigator · UKT, IKP Stuttgart

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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