- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03934957
Hamburg City Health Study - a German Cohort Study (HCHS)
April 28, 2019 updated by: Universitätsklinikum Hamburg-Eppendorf
A Single Center, Prospective, Epidemiologic Cohort Study With Emphasis on Imaging to Improve the Identification of Individuals at Risk for Major Chronic Diseases and to Improve Early Diagnosis and Survival
The Hamburg City Health Study (HCHS) is a large, prospective, long-term, population-based cohort study and a unique research platform and network to obtain substantial knowledge about several risk and prognostic factors in major chronic diseases.
Study Overview
Status
Recruiting
Detailed Description
A random sample of 45.000 participants between 45 and 74 years of age from the general population of Hamburg, Germany, will take part in an extensive baseline assessment at a dedicated study center.
Participants undergo 13 validated and 5 novel examinations primarily targeting cardiac, arterio-venous and cerebral function and structure including extensive imaging examinations.
The protocol includes self-ratings of life style and environmental conditions, , dietary habits, physical activity, professional life, psychosocial context, , digital media use, medical and family history as well as health care utilization patterns.
The assessment is completed by genomic and proteomic characterization.
Beyond the identification of classical risk factors for major chronic diseases and survivorship, the core intention is to develop complex models predicting health outcomes based on a multitude of examination data, imaging data and behavioral assessments.
Participants at risk for coronary artery disease, atrial fibrillation, heart failure, stroke and dementia will be invited for a visit to conduct additional MRI examination either of heart or brain.
Endpoint assessment of the overall sample will be completed through repeated follow-up examinations and data from involved health and pension insurances.
Study Type
Observational
Enrollment (Anticipated)
45000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Annika Jagodzinski, MD
- Phone Number: 0049741059328
- Email: A.Jagodzinski@uke.de
Study Contact Backup
- Name: Tanja Zeller, Professor
- Phone Number: 0049741056045
- Email: t.zeller@uke.de
Study Locations
-
-
-
Hamburg, Germany, 20246
- Recruiting
- Universitätsklinikum Hamburg-Eppendorf
-
Contact:
- Susannw Bruder
- Phone Number: 00494056045
- Email: s.bruder@uke.de
-
-
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
Ages Eligible for Study
45 years to 74 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Population based cohort, participants are identified by a random sample from the official inhabitant data file divided into gender and six age strata.
Description
Inclusion Criteria:
- Inhabitant of the city of Hamburg at the time of inclusion into the study (Inclusion is time of written consent)
- Age 45 to 74 years
- Personally signed informed consent
Exclusion Criteria:
- Insufficient knowledge of the German language, in order to understand study documents and computer assisted interview without translation
- Physical or psychological incapability to travel to the study center and to cooperate in the investigations
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
self-reported Information on changes in health in the participants
Time Frame: yearly up to 12 years
|
coronary artery disease atrial fibrillation heart failure dementia stroke cancer such as prostate cancer and skin cancer chronic kidney diseases migraine musculoskeletal diseases such as osteoporosis and bone metastasis ocular diseases such as glaucoma, macular degeneration, fundus hypertonicus, retinal vessel disease and neoplasm oral health including periodontal disease, oropharyngeal cancer and human papillomavirus (HPV)-infection psychiatric and psychosomatic disorders such as mental disorder or late - last depression pulmonary diseases such as obstructive lung disease sexual disorder skin diseases such as psoriasis, chronic wounds and inflammation vascular diseases such as aortic aneurysm, thrombosis and peripheral arterial disease
|
yearly up to 12 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stefan Blankenberg, Professor, Universitäres Herzzentrum Hamburg
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
- Cavus E, Schneider JN, Bei der Kellen R, di Carluccio E, Ziegler A, Tahir E, Bohnen S, Avanesov M, Radunski UK, Chevalier C, Jahnke C, Ojeda F, Kirchhof P, Blankenberg S, Adam G, Lund GK, Muellerleile K. Impact of Sex and Cardiovascular Risk Factors on Myocardial T1, Extracellular Volume Fraction, and T2 at 3 Tesla: Results From the Population-Based, Hamburg City Health Study. Circ Cardiovasc Imaging. 2022 Sep;15(9):e014158. doi: 10.1161/CIRCIMAGING.122.014158. Epub 2022 Sep 20.
- Zyriax BC, Borof K, Walter S, Augustin M, Windler E. Knowledge as to cholesterol reduction and use of phytosterol-enriched dietary foods in the general population: Insights from the Hamburg City Health Study. Atherosclerosis. 2022 Jan;341:1-6. doi: 10.1016/j.atherosclerosis.2021.12.004. Epub 2021 Dec 12.
- Jacobi N, Walther C, Borof K, Heydecke G, Seedorf U, Lamprecht R, Beikler T, Debus SE, Waldeyer C, Blankenberg S, Schnabel RB, Aarabi G, Behrendt CA. The Association of Periodontitis and Peripheral Arterial Occlusive Disease in a Prospective Population-Based Cross-Sectional Cohort Study. J Clin Med. 2021 May 11;10(10):2048. doi: 10.3390/jcm10102048.
Helpful Links
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 (ACTUAL)
February 8, 2016
Primary Completion (ANTICIPATED)
December 31, 2022
Study Completion (ANTICIPATED)
December 31, 2028
Study Registration Dates
First Submitted
January 4, 2019
First Submitted That Met QC Criteria
April 28, 2019
First Posted (ACTUAL)
May 2, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 2, 2019
Last Update Submitted That Met QC Criteria
April 28, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PV5131
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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