ASS-Nonresponse Following Cardiac Surgery as Assessed With Multiple Electrode Aggregometry

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Goethe University
Sponsor:
Collaborator:
University Hospital Goettingen
Information provided by (Responsible Party):
Christian F. Weber, MD, Goethe University
ClinicalTrials.gov Identifier:
NCT01824147
First received: March 26, 2013
Last updated: March 14, 2014
Last verified: March 2014

March 26, 2013
March 14, 2014
August 2013
May 2014   (final data collection date for primary outcome measure)
ASPItest [ Time Frame: at day 3 and 5 after the first dose of aspirin following surgery ] [ Designated as safety issue: No ]
Area under the aggregation curve following stimulation with arachidonic acid in the Multiple Electrode Aggregometry (MEA)
Same as current
Complete list of historical versions of study NCT01824147 on ClinicalTrials.gov Archive Site
  • TRAPtest [ Time Frame: at day 3 and 5 after the first dose of aspirin following surgery ] [ Designated as safety issue: No ]
    Area under the aggregation curve in the Multiple Electrode Aggregometry following stimulation with thrombin receptor activating peptide 6
  • Platelet Count [ Time Frame: at day 3 and 5 after the first dose of aspirin following surgery ] [ Designated as safety issue: No ]
    Platelet count taken from the daily standard laboratory results.
  • Mortality [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Mortality will be assessed by a telephonic follow up interview 12 month after enrollment into the study
  • Myocardial infarction [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Occurrence of a myocardial infarction during the 12 month following surgery assessed in a telephonic follow up interview.
  • Readmission to hospital [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Did a readmission to hospital due to cardiac or pulmonary reasons take place in the 12 month following enrollment into the study? Assessed by a telephonic follow up interview.
Same as current
  • Age [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]
    Age of the patient in years at the time of enrollment
  • Height [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]
    Height of the patient in centimeters at the time of enrollment
  • Weight [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]
    Weight of the patient in kilograms at enrollment
  • Gender [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]
    Gender of the patient
  • LDL cholesterol [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]
    LDL cholesterol of the patient in mg/dl at enrollment
  • nicotine [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]

    Smoking habits of the patient will be documented at enrollment in the categories:

    • active smoker
    • non smoker
  • European system for cardiac operative risk evaluation (EuroSCORE) [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]
    EuroSCORE as assessed on admission will be documented.
  • Diabetes [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]

    Risk factor diabetes will be documented in the following categories at enrollment:

    • Diabetes Typ I
    • Diabetes Typ II without the need for insulin substitution
    • Diabetes Typ II with the need for insulin substitution
  • Surgical procedure [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]
    The surgical procedure performed will be documented.
  • phone number [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]
    The phone will be documented for the 12 month follow up interview.
Same as current
 
ASS-Nonresponse Following Cardiac Surgery as Assessed With Multiple Electrode Aggregometry
ASS-Nonresponse Following Cardiac Surgery as Assessed With Multiple Electrode Aggregometry

It is the aim of the present study to assess the prevalence of ASS-Nonresponse following cardiac surgery using the Multiple Electrode Aggregometry (MEA).

Up to now there are no data concerning the prevalence of ASS-Nonresponse following surgical coronary revascularization procedures as assessed with the Multiple Electrode Aggregometry. Results of the present observational study are needed to assess the prevalence of ASS-Nonresponse in order to perform a sample size analysis for a prospective interventional study in a second step.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients following cardiac surgery and a antiaggregatory therapy with aspirin

ASS-Nonresponse
Not Provided
CABG Patients
Patients undergoing surgery for coronary revascularization.
Collet JP, Cuisset T, Rangé G, Cayla G, Elhadad S, Pouillot C, Henry P, Motreff P, Carrié D, Boueri Z, Belle L, Van Belle E, Rousseau H, Aubry P, Monségu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Barthélémy O, Beygui F, Silvain J, Vicaut E, Montalescot G; ARCTIC Investigators. Bedside monitoring to adjust antiplatelet therapy for coronary stenting. N Engl J Med. 2012 Nov 29;367(22):2100-9. doi: 10.1056/NEJMoa1209979. Epub 2012 Nov 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Not Provided
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients older than 18 years after cardiac surgery
  • Antiaggregatory therapy with aspirin postoperatively

Exclusion Criteria:

  • known allergy to aspirin
  • need for an antiaggregatory therapy other than aspirin
  • pregnancy
Both
18 Years and older
No
Contact: Saskia Wand, Dr. med. 0049 551 398826 saskia.wand@med.uni-goettingen.de
Contact: Christian F Weber, Dr. med. 0049 157 76400777 Christian.Weber@kgu.de
Germany
 
NCT01824147
33/13
No
Christian F. Weber, MD, Goethe University
Goethe University
University Hospital Goettingen
Principal Investigator: Christian F Weber, MD Cooperative Weichteilsarkom Study Group
Goethe University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP