Heart DiseasesNCT02488876
Database of Tissue Samples to Understand the Inflammatory Response After Cardiac Surgery
An observational study of Heart Diseases, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Diseases
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Dec 2099
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients scheduled for cardiac surgery
Who may be able to join
- Patients undergoing cardiac surgery
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital RWTH Aachen, Department of Thoracic and Cardiovascular Surgery
Aachen, North Rhine-Westphalia, 52074
Andreas Goetzenich, PD Dr. med., +49 241 80 35556, agoetzenich@ukaachen.de
About this study
Official title: Non-individual Related Ongoing Collection of Blood Samples for the Compilation of a Unique Database of Tissue Samples to Understand the Inflammatory Response After Cardiac Surgery
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.
- Conditions
- Heart Diseases
- Keywords
- Cardiac surgery, Tissue sample database, Inflammatory responds
- Medical subject headings
- Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Cytokines
Measured: Perioperatively until 7 days after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startApr 2009
- Primary completionDec 2099 (estimated)
- Study completionDec 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Goetzenich, PD Dr. med., Principal investigator, Department of Cardiothoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488876
- Sponsor's protocol ID
- EK 151/09
- Status last verified
- Oct 2017
- First submitted
- 4 May 2015
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30583965
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-individual Related Ongoing Collection of Blood Samples for the Compilation of a Unique Database of Tissue Samples to Understand the Inflammatory Response After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02488876
- Acronym / sponsor ID
- EK 151/09
- Conditions
- Heart Diseases
- Keywords
- Cardiac surgery, Tissue sample database, Inflammatory responds
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2099 (estimated)
- Study completion
- Dec 2099 (estimated)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients scheduled for cardiac surgery
Key inclusion criteria (1 listed)
- Patients undergoing cardiac surgery
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inflammatory Cytokines
Time frame: Perioperatively until 7 days after cardiac surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Derived from this study: PubMed 30583965Ney 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.
Related trials for Heart Diseases
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreas Goetzenich, PD Dr. med. principal investigator
Department of Cardiothoracic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Goetzenich, PD Dr. med. (+49 241 80 35556, agoetzenich@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Cytokines (time frame: Perioperatively until 7 days after cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02488876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.