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).

Study Overview

• Status: Completed
• Conditions: ASS-Nonresponse

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Goethe - University
  • Lower Saxony
    • Goettingen, Lower Saxony, Germany, 37073
      • University Hospital Goettingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients following cardiac surgery and a antiaggregatory therapy with aspirin

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CABG Patients; Patients undergoing surgery for coronary revascularization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASPItest	Area under the aggregation curve following stimulation with arachidonic acid in the Multiple Electrode Aggregometry (MEA)	at day 3 and 5 after the first dose of aspirin following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TRAPtest	Area under the aggregation curve in the Multiple Electrode Aggregometry following stimulation with thrombin receptor activating peptide 6	at day 3 and 5 after the first dose of aspirin following surgery
Platelet Count	Platelet count taken from the daily standard laboratory results.	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	12 month
Myocardial infarction	Occurrence of a myocardial infarction during the 12 month following surgery assessed in a telephonic follow up interview.	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.	12 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age of the patient in years at the time of enrollment	at the day of enrollment
Height	Height of the patient in centimeters at the time of enrollment	at the day of enrollment
Weight	Weight of the patient in kilograms at enrollment	at the day of enrollment
Gender	Gender of the patient	at the day of enrollment
LDL cholesterol	LDL cholesterol of the patient in mg/dl at enrollment	at the day of enrollment
nicotine	Smoking habits of the patient will be documented at enrollment in the categories: active smoker; non smoker	at the day of enrollment
European system for cardiac operative risk evaluation (EuroSCORE)	EuroSCORE as assessed on admission will be documented.	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	at the day of enrollment
Surgical procedure	The surgical procedure performed will be documented.	at the day of enrollment
phone number	The phone will be documented for the 12 month follow up interview.	at the day of enrollment

Collaborators and Investigators

• Sponsor: Goethe University
• Collaborators: University Hospital Goettingen
• Investigators: Principal Investigator: Christian F Weber, MD, Goethe University Frankfurt

Publications and helpful links

General Publications

• Collet JP, Cuisset T, Range G, Cayla G, Elhadad S, Pouillot C, Henry P, Motreff P, Carrie D, Boueri Z, Belle L, Van Belle E, Rousseau H, Aubry P, Monsegu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Barthelemy 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: March 26, 2013
• First Submitted That Met QC Criteria: March 31, 2013
• First Posted (Estimate): April 4, 2013

Study Record Updates

• Last Update Posted (Estimate): February 24, 2016
• Last Update Submitted That Met QC Criteria: February 23, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: surgery; cardiac; ASS-Nonresponse
• Other Study ID Numbers: 33/13