Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-02-18 @ 10:22 AM
Study NCT ID:
NCT04166903
Status:
COMPLETED
Last Update Posted:
2025-09-17
First Post:
2019-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Follow-up, Marathon, Long Term, Inflammation and Cardiovascular System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood sample: whole blood, serum, plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 277}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2019-11-13', 'studyFirstSubmitQcDate': '2019-11-14', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of right ventricular systolic function (RV-EF)', 'timeFrame': '10 years', 'description': 'Echocardiography'}], 'secondaryOutcomes': [{'measure': 'Changes in left ventricular ejection fraction (LV-EF)', 'timeFrame': '10 years', 'description': 'Echocardiography'}, {'measure': 'Changes in left ventricular diastolic function (E/e´)', 'timeFrame': '10 years', 'description': 'Echocardiography'}, {'measure': 'Change in cardiac markers (e.g. cardiac Troponin)', 'timeFrame': '10 years', 'description': 'Clinical chemistry (blood samples)'}, {'measure': 'Change in inflammation markers (e.g. C-reactive Protein)', 'timeFrame': '10 years', 'description': 'Clinical chemistry (blood samples)'}, {'measure': 'Change in microcirculation (e.g. arteriolar-to-venular ratio)', 'timeFrame': '10 years', 'description': 'Static Retinal Vessel Analyzer'}, {'measure': 'Change in macrocirculation (e.g. Intima media thickness)', 'timeFrame': '10 years', 'description': 'Carotid sonography'}, {'measure': 'Change of prevalence of cardiovascular diseases', 'timeFrame': '10 years', 'description': 'Questionnaire'}, {'measure': 'Association between changes of aforementioned parameters (see Topics 1-8) and potential underlying causes (e.g. sports history like number of ultraendurance competitions) in the examined cohort', 'timeFrame': '10 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prolonged exercise, marathon, cardiovascular disease, long term'], 'conditions': ['Participants of the Be-MaGIC-Study 2009']}, 'referencesModule': {'references': [{'pmid': '7371022', 'type': 'BACKGROUND', 'citation': 'Matsushima M, Bryan GT. Early induction of mouse urinary bladder ornithine decarboxylase activity by rodent vesical carcinogens. Cancer Res. 1980 Jun;40(6):1897-901.'}, {'pmid': '32704381', 'type': 'DERIVED', 'citation': 'Schoenfeld J, Schindler MJ, Haller B, Holdenrieder S, Nieman DC, Halle M, La Gerche A, Scherr J. Prospective long-term follow-up analysis of the cardiovascular system in marathon runners: study design of the Pro-MagIC study. BMJ Open Sport Exerc Med. 2020 Jul 19;6(1):e000786. doi: 10.1136/bmjsem-2020-000786. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'Pro-MagIC is a prospective observational study and includes participants of the Be-MaGIC-Study 2009 (n=277/NCT00933218). We aim to detect exercise-induced physiological changes (inter alia of the cardiovascular system) induced by repetitive ultra-endurance strain over a period of 10 years.', 'detailedDescription': 'Physical activity is associated with health benefits. Acute prolonged and strenuous exercise, i.e. Marathon running, leads to hemodynamic, endothelial and myocardial functional changes. Whether these myocardial, endothelial and hemodynamic changes can also develop and persist through repetitive extreme and prolonged physical activity is currently still a matter of controversy. In addition, it is not known whether adaptations and changes over time can develop into clinically relevant cardiovascular events with negative health consequences in healthy athletes. The aim of this study is to detect exercise-induced physiological changes (inter alia of the cardiovascular system) induced by repetitive ultra-endurance strain over a period of 10 years.\n\nFor this purpose, 277 male participants from the Be-MaGIC study (Marathon 2009) are examined in this prospective observational study. A single examination with the following components will take place: Anthropometry, clinical examination, laboratory, resting / exercise electrocardiography cardiopulmonary stress test, echocardiography, and fundus camera. Further examinations will be conducted in participants with abnormal examination results in line with current clinical recommendations.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants of the Be-MaGIC-Study (2009)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDeclaration of consent Participants must have participated in the Be-MaGIC study in 2009\n\n* current age: 30 - 70 years\n* sex: male\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04166903', 'acronym': 'Pro-MagIC', 'briefTitle': 'Prospective Follow-up, Marathon, Long Term, Inflammation and Cardiovascular System', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Prospective Long Term Follow-up Analysis of Exercise-induced Physiological Changes in Male Runners', 'orgStudyIdInfo': {'id': 'ProMagIC-Study'}}, 'contactsLocationsModule': {'locations': [{'zip': '80992', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Michael Schindler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany'}, {'name': 'Johannes Scherr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Balgrist, University Zurich, Switzerland'}, {'name': 'Martin Halle, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Balgrist University Hospital', 'class': 'OTHER'}, {'name': 'Deutsches Herzzentrum Muenchen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Johannes Scherr', 'investigatorFullName': 'Johannes Scherr', 'investigatorAffiliation': 'Balgrist University Hospital'}}}}