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

February 23, 2016 updated by: Christian F. Weber, MD, Goethe University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
CABG Patients
Patients undergoing surgery for coronary revascularization.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ASPItest
Time Frame: at day 3 and 5 after the first dose of aspirin following surgery
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TRAPtest
Time Frame: at day 3 and 5 after the first dose of aspirin following surgery
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
Time Frame: at day 3 and 5 after the first dose of aspirin following surgery
Platelet count taken from the daily standard laboratory results.
at day 3 and 5 after the first dose of aspirin following surgery
Mortality
Time Frame: 12 month
Mortality will be assessed by a telephonic follow up interview 12 month after enrollment into the study
12 month
Myocardial infarction
Time Frame: 12 month
Occurrence of a myocardial infarction during the 12 month following surgery assessed in a telephonic follow up interview.
12 month
Readmission to hospital
Time Frame: 12 month
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age
Time Frame: at the day of enrollment
Age of the patient in years at the time of enrollment
at the day of enrollment
Height
Time Frame: at the day of enrollment
Height of the patient in centimeters at the time of enrollment
at the day of enrollment
Weight
Time Frame: at the day of enrollment
Weight of the patient in kilograms at enrollment
at the day of enrollment
Gender
Time Frame: at the day of enrollment
Gender of the patient
at the day of enrollment
LDL cholesterol
Time Frame: at the day of enrollment
LDL cholesterol of the patient in mg/dl at enrollment
at the day of enrollment
nicotine
Time Frame: at the day of enrollment

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)
Time Frame: at the day of enrollment
EuroSCORE as assessed on admission will be documented.
at the day of enrollment
Diabetes
Time Frame: at the day of enrollment

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
Time Frame: at the day of enrollment
The surgical procedure performed will be documented.
at the day of enrollment
phone number
Time Frame: at the day of enrollment
The phone will be documented for the 12 month follow up interview.
at the day of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Goethe University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital Goettingen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christian F Weber, MD, Goethe University Frankfurt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 33/13

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