Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-09 @ 8:21 PM
Study NCT ID:
NCT03218020
Status:
COMPLETED
Last Update Posted:
2017-07-18
First Post:
2017-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Red Meat, Increased Iron Load and CVD Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum samples from baseline examinations stored in the biobank of the study.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25540}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2009-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-14', 'studyFirstSubmitDate': '2017-07-13', 'studyFirstSubmitQcDate': '2017-07-13', 'lastUpdatePostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial infraction', 'timeFrame': '1994 - 2009', 'description': 'Incident cases of primary myocardial infarction according to clinical records'}, {'measure': 'Stroke', 'timeFrame': '1994 - 2009', 'description': 'Incident cases of primary stroke according to clinical records'}, {'measure': 'Cardiovascular death', 'timeFrame': '1994 - 2009', 'description': 'Incident cases of cardiovascular death according to death certificates'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction', 'Stroke', 'Cardiovascular Mortality']}, 'descriptionModule': {'briefSummary': 'Increased iron load could be a risk factor for cardiovascular diseases (CVD). Red meat consumption affects iron status and has also been shown to be related to increased CVD risk. The investigators hypothesized that risk associations between red meat intake and cardiovascular disease risk can to some degree be explained by higher iron load among individuals with higher meat intake. Thus, the investigators evaluate associations between red meat consumption, iron status, and CVD risk in a large-scale population based study, the European Prospective Investigation into Cancer and Nutrition (EPIC) - Heidelberg.', 'detailedDescription': 'The present study part of the the European Prospective Investigation into Cancer and Nutrition (EPIC) - Heidelberg, a large-scale observational cohort study located at the German Cancer Research Center, Heidelberg, Germany. The study started between 1994 and 1998, when 25 540 adults from the local general population were recruited. Study participants are being followed-up by active and passive procedures. The main aim of the study is to evaluate associations between diet, lifestyle as well as metabolism and risks of major chronic diseases (cancer, cardiovascular diseases, diabetes).\n\nHere, the investigators register a project from within EPIC-Heidelberg on prediagnostic iron status as a potential mediator of associations between pre-diagnostic red meat consumption and cardiovascular disease risk. For this particular project, an embedded case-cohort set-up was chosen, i.e. iron status markers (primary marker: serum ferritin; secondary markers: serum transferrin, serum iron) were measured in baseline blood samples from a random subcohort (n=2738) and all validated incident cases of myocardial infarction (n=556), stroke (n=513), and CVD death (n=327) that occured until the closure date of the present study (12-31-2009).\n\nStatistical analyses follow four steps to assess whether iron status may mediate associations between red meat consumption and CVD risk, as proposed by Wittenbecher et al. (Am J Clin Nutr, 2015: www.ncbi.nlm.nih.gov/pubmed/25948672):\n\n1. Multivariable Cox regression analyses on red meat consumption and CVD risk, assuming a significant positive association\n2. Multivariable linear regression analyses on red meat consumption and iron status, assuming a significant positive association\n3. Multivariable Cox regression analyses on iron status and CVD risk, assuming a significant positive association\n4. Multivariable Cox regression analyses on red meat consumption and CVD risk, additionally adjusting for iron status, assuming that the association will be attenuated by adjustment for iron status'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'EPIC-Heidelberg was launched as part of EPIC-Europe between 1994 and 1998, when 13 611 female and 11 929 male participants aged 35 to 65 years were recruited from the local general population.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral population, age 35-65 years\n\nExclusion Criteria:\n\nPrevalent myocardial infraction or stroke'}, 'identificationModule': {'nctId': 'NCT03218020', 'briefTitle': 'Red Meat, Increased Iron Load and CVD Risk', 'organization': {'class': 'OTHER', 'fullName': 'German Cancer Research Center'}, 'officialTitle': 'Red Meat Consumption and Risk of Cardiovascular Diseases - is Increased Iron Load a Possible Link?', 'orgStudyIdInfo': {'id': 'DKFZ Study_ID 905'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Random Subcohort', 'description': 'Random subcohort (\\~10 % of the initial cohort, study has a case-cohort design; details on the case-cohort design have been described by Kulathinal et al., Epidemiol Perspect Innov, 2007: www.ncbi.nlm.nih.gov/pmc/articles/PMC2216006/).', 'interventionNames': ['Other: No intervention assigned, this is an observational study.']}, {'label': 'Incident CVD Cases', 'description': 'Validated incident cases of myocardial infarction, stroke and CVD death that occured until Dec-31-2009 (details on the case-cohort design have been described by Kulathinal et al., Epidemiol Perspect Innov, 2007: www.ncbi.nlm.nih.gov/pmc/articles/PMC2216006/).', 'interventionNames': ['Other: No intervention assigned, this is an observational study.']}], 'interventions': [{'name': 'No intervention assigned, this is an observational study.', 'type': 'OTHER', 'description': 'No intervention assigned, this is an observational study.', 'armGroupLabels': ['Incident CVD Cases', 'Random Subcohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'German Cancer Research Center', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Rudolf Kaaks, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'German Cancer Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Cancer Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}