Clinical trial NCT03934957: Hamburg City Health Study - a German Cohort Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Heart Disease
Stroke
Dementia
Cancer
Health Care
Vascular Diseases
Periodontal Diseases
Ocular Diseases
Respiratory Disease
Obesity
Keywords: Epidemiology
prospective cohort study
Nutrition
prevention
psychiatric and psychosomatic disorders
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Universitäres Herzzentrum Hamburg-Eppendorf
name: Martini-Klinik am UKE GmbH
First posted: 2019-05-02
Enrollment: 45000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: self-reported Information on changes in health in the participants
timeFrame: yearly up to 12 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Universitäres Herzzentrum Hamburg
name: Stefan Blankenberg, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.