Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-01-01 @ 10:30 PM
Study NCT ID:
NCT03934957
Status:
RECRUITING
Last Update Posted:
2019-05-02
First Post:
2019-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hamburg City Health Study - a German Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D011602', 'term': 'Psychophysiologic Disorders'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, plasma (EDTA, citrate), genomic deoxyribonucleic acid (DNA), ribonucleic acid (RNA) from whole blood and peripheral blood mononuclear cells (PBMCs), blood cells (erythrocytes, PBMCs), urine, saliva, tooth fluid, tonsils swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-28', 'studyFirstSubmitDate': '2019-01-04', 'studyFirstSubmitQcDate': '2019-04-28', 'lastUpdatePostDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'self-reported Information on changes in health in the participants', 'timeFrame': 'yearly up to 12 years', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epidemiology', 'prospective cohort study', 'Nutrition', 'prevention', 'psychiatric and psychosomatic disorders'], 'conditions': ['Coronary Heart Disease', 'Stroke', 'Dementia', 'Cancer', 'Health Care', 'Vascular Diseases', 'Periodontal Diseases', 'Ocular Diseases', 'Respiratory Disease', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '40609062', 'type': 'DERIVED', 'citation': 'Jensen M, Vettorazzi E, Weber P, Petersen M, Schell M, Nagele FL, Link MA, Schlemm E, Rimmele DL, Becher PM, Cheng B, Blankenberg S, Kirchhof P, Zeller T, Twerenbold R, Thomalla G. Association of Cardiac Biomarkers With Structural Brain Changes and Cognitive Impairment: Results From the Hamburg City Health Study. Neurology. 2025 Aug 12;105(3):e213865. doi: 10.1212/WNL.0000000000213865. Epub 2025 Jul 3.'}, {'pmid': '40353872', 'type': 'DERIVED', 'citation': 'Wenzel JP, Albrecht JN, Toprak B, Petersen E, Nikorowitsch J, Cavus E, Jahnke C, Riedl KA, Adam G, Twerenbold R, Blankenberg S, Kirchhof P, Lund G, Tahir E, Mullerleile K, Radunski UK. Head-to-head comparison of cardiac magnetic resonance imaging and transthoracic echocardiography in the general population (MATCH). Clin Res Cardiol. 2025 May 12. doi: 10.1007/s00392-025-02660-1. Online ahead of print.'}, {'pmid': '39156216', 'type': 'DERIVED', 'citation': 'Rimmele DL, Petersen EL, Affolderbach S, Petersen M, Cheng B, Mayer C, Nagele FL, Harth V, Terschuren C, Kuhn S, Zeller T, Gerloff C, Thomalla G. Differences in impact of current and former shift work on cardiovascular risk factors, carotid atherosclerosis, and white matter integrity. Sleep Adv. 2024 Jul 31;5(1):zpae056. doi: 10.1093/sleepadvances/zpae056. eCollection 2024.'}, {'pmid': '38341145', 'type': 'DERIVED', 'citation': 'Cavus E, Schneider JN, di Carluccio E, Ziegler A, Haack A, Ojeda F, Chevalier C, Jahnke C, Riedl KA, Radunski UK, Twerenbold R, Kirchhof P, Blankenberg S, Adam G, Tahir E, Lund GK, Muellerleile K. Unrecognized myocardial scar by late-gadolinium-enhancement cardiovascular magnetic resonance: Insights from the population-based Hamburg City Health Study. J Cardiovasc Magn Reson. 2024 Summer;26(1):101008. doi: 10.1016/j.jocmr.2024.101008. Epub 2024 Feb 9.'}, {'pmid': '36644504', 'type': 'DERIVED', 'citation': 'Rimmele DL, Borof K, Wenzel JP, Jensen M, Behrendt CA, Waldeyer C, Schnabel RB, Zeller T, Debus ES, Blankenberg S, Gerloff C, Thomalla G. Differential association of flow velocities in the carotid artery with plaques, intima media thickness and cardiac function. Atheroscler Plus. 2021 Jul 31;43:18-23. doi: 10.1016/j.athplu.2021.07.020. eCollection 2021 Sep.'}, {'pmid': '36126126', 'type': 'DERIVED', '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.'}, {'pmid': '36123124', 'type': 'DERIVED', 'citation': 'Rimmele DL, Petersen EL, Schlemm E, Kessner SS, Petersen M, Mayer C, Cheng B, Zeller T, Waldeyer C, Behrendt CA, Gerloff C, Thomalla G. Association of Carotid Plaque and Flow Velocity With White Matter Integrity in a Middle-aged to Elderly Population. Neurology. 2022 Dec 12;99(24):e2699-e2707. doi: 10.1212/WNL.0000000000201297.'}, {'pmid': '34922192', 'type': 'DERIVED', '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.'}, {'pmid': '34064657', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Population based cohort, participants are identified by a random sample from the official inhabitant data file divided into gender and six age strata.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inhabitant of the city of Hamburg at the time of inclusion into the study (Inclusion is time of written consent)\n* Age 45 to 74 years\n* Personally signed informed consent\n\nExclusion Criteria:\n\n* Insufficient knowledge of the German language, in order to understand study documents and computer assisted interview without translation\n* Physical or psychological incapability to travel to the study center and to cooperate in the investigations'}, 'identificationModule': {'nctId': 'NCT03934957', 'acronym': 'HCHS', 'briefTitle': 'Hamburg City Health Study - a German Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PV5131'}}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Susannw Bruder', 'role': 'CONTACT', 'email': 's.bruder@uke.de', 'phone': '00494056045'}], 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Annika Jagodzinski, MD', 'role': 'CONTACT', 'email': 'A.Jagodzinski@uke.de', 'phone': '0049741059328'}, {'name': 'Tanja Zeller, Professor', 'role': 'CONTACT', 'email': 't.zeller@uke.de', 'phone': '0049741056045'}], 'overallOfficials': [{'name': 'Stefan Blankenberg, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitäres Herzzentrum Hamburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitäres Herzzentrum Hamburg-Eppendorf', 'class': 'UNKNOWN'}, {'name': 'Martini-Klinik am UKE GmbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}