NCT02488876

Brief Summary

The aim of this study is to collect non-individual related blood samples for the compelling of a unique database of tissue samples to understand the inflammatory responds after cardiac surgery on an on-going basis. This includes especially protein analyses and genetic testing for certain neurotransmitters in the blood and tissues to understand disease markers related to heart disease. The study is designed as an openly recruiting biobank with the purpose to later serve multiple study purposes. Outcomes refer to protein analyses and genetic testing for neurotransmitters in the blood and tissues.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
895mo left

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Apr 2009Dec 2099

Study Start

First participant enrolled

April 1, 2009

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
84.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2099

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2099

Last Updated

October 3, 2017

Status Verified

October 1, 2017

Enrollment Period

90.7 years

First QC Date

May 4, 2015

Last Update Submit

October 2, 2017

Conditions

Heart Diseases

Keywords

Cardiac surgeryTissue sample databaseInflammatory responds

Outcome Measures

Primary Outcomes (1)

  • Inflammatory Cytokines

    Perioperatively until 7 days after cardiac surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients scheduled for cardiac surgery

You may qualify if:

  • Patients undergoing cardiac surgery

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital RWTH Aachen, Department of Thoracic and Cardiovascular Surgery

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

Related Publications (1)

  • Ney J, Heyland DK, Amrein K, Marx G, Grottke O, Choudrakis M, Autschbach T, Hill A, Meybohm P, Benstoem C, Goetzenich A, Fitzner C, Stoppe C. The relevance of 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D concentration for postoperative infections and postoperative organ dysfunctions in cardiac surgery patients: The eVIDenCe study. Clin Nutr. 2019 Dec;38(6):2756-2762. doi: 10.1016/j.clnu.2018.11.033. Epub 2018 Dec 13.

    PMID: 30583965DERIVED

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Andreas Goetzenich, PD Dr. med.

    Department of Cardiothoracic Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Goetzenich, PD Dr. med.

CONTACT

+49 241 80 35556agoetzenich@ukaachen.de

Christian Stoppe, PD Dr. med.

CONTACT

+49 241 80 36575cstoppe@ukaachen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2015

First Posted

July 2, 2015

Study Start

April 1, 2009

Primary Completion (Estimated)

December 1, 2099

Study Completion (Estimated)

December 1, 2099

Last Updated

October 3, 2017

Record last verified: 2017-10

Locations

DE(1)