Database of Tissue Samples to Understand the Inflammatory... | NCT02488876

Studies
Database of Tissue Samples to Understand the Inflammatory Response After Cardiac Surgery

NCT02488876

Sponsor

RWTH Aachen University

Status

Recruiting

Last Update Posted

Oct 3, 2017Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Heart Diseases

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Dec 2099Estimated

Completion Date

Dec 2099Estimated

First Submitted Date

May 4, 2015

First Submission Date that Met QC Criteria

Jul 1, 2015

First Posted Date

Jul 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2017

Last Update Posted Date

Oct 3, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

7 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Inflammatory Cytokines		Perioperatively until 7 days after cardiac surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing cardiac surgery

Exclusion Criteria:

None.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients scheduled for cardiac surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andreas Goetzenich, PD Dr. med.	Contact	+49 241 80 35556		agoetzenich@ukaachen.de
Christian Stoppe, PD Dr. med.	Contact	+49 241 80 36575		cstoppe@ukaachen.de

Overall Officials

Name	Affiliation	Role
Andreas Goetzenich, PD Dr. med.	Department of Cardiothoracic Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital RWTH Aachen, Department of Thoracic and Cardiovascular Surgery	Recruiting	Aachen	North Rhine-Westphalia	52074	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30583965	Derived	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.