An observational study in ASS-Nonresponse, sponsored by Goethe University. Completed at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-24.
Sponsored by Goethe University · Observational
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.
Goethe University is the lead sponsor of 97 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients following cardiac surgery and a antiaggregatory therapy with aspirin
Exclusion Criteria:
Patients undergoing surgery for coronary revascularization.
ASPItest
Area under the aggregation curve following stimulation with arachidonic acid in the Multiple Electrode Aggregometry (MEA)
Time frame: at day 3 and 5 after the first dose of aspirin following surgery
TRAPtest
Area under the aggregation curve in the Multiple Electrode Aggregometry following stimulation with thrombin receptor activating peptide 6
Time frame: at day 3 and 5 after the first dose of aspirin following surgery
Platelet Count
Platelet count taken from the daily standard laboratory results.
Time frame: at day 3 and 5 after the first dose of aspirin following surgery
Mortality
Mortality will be assessed by a telephonic follow up interview 12 month after enrollment into the study
Time frame: 12 month
Myocardial infarction
Occurrence of a myocardial infarction during the 12 month following surgery assessed in a telephonic follow up interview.
Time frame: 12 month
Readmission to hospital
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.
Time frame: 12 month
Age
Age of the patient in years at the time of enrollment
Time frame: at the day of enrollment
Height
Height of the patient in centimeters at the time of enrollment
Time frame: at the day of enrollment
Weight
Weight of the patient in kilograms at enrollment
Time frame: at the day of enrollment
Gender
Gender of the patient
Time frame: at the day of enrollment
LDL cholesterol
LDL cholesterol of the patient in mg/dl at enrollment
Time frame: at the day of enrollment
nicotine
Smoking habits of the patient will be documented at enrollment in the categories: * active smoker * non smoker
Time frame: at the day of enrollment
European system for cardiac operative risk evaluation (EuroSCORE)
EuroSCORE as assessed on admission will be documented.
Time frame: at the day of enrollment
Diabetes
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
Time frame: at the day of enrollment
Surgical procedure
The surgical procedure performed will be documented.
Time frame: at the day of enrollment
phone number
The phone will be documented for the 12 month follow up interview.
Time frame: at the day of enrollment
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Goethe University