Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-02-25 @ 4:36 PM
Study NCT ID:
NCT00486993
Status:
COMPLETED
Last Update Posted:
2016-11-08
First Post:
2007-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Risk Factors in an Ambulatory Urban Patient Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular 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': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18287}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-05', 'studyFirstSubmitDate': '2007-06-12', 'studyFirstSubmitQcDate': '2007-06-14', 'lastUpdatePostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiovascular mortality', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'mortality, other causes', 'timeFrame': 'one year'}, {'measure': 'acute myocardial infarction', 'timeFrame': 'one year'}, {'measure': 'stroke', 'timeFrame': 'one year'}, {'measure': 'acute coronary syndrome', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diet', 'Exercise', 'Smoking', 'Stress', 'Polyphenols'], 'conditions': ['Cardiovascular Risk Factors', 'Metabolic Syndrome', 'Lifestyle Modification', 'Coronary Artery Disease', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '9585400', 'type': 'BACKGROUND', 'citation': 'Jimenez JT, Palacios M, Canete F, Barriocanal LA, Medina U, Figueredo R, Martinez S, de Melgarejo MV, Weik S, Kiefer R, Alberti KG, Moreno-Azorero R. Prevalence of diabetes mellitus and associated cardiovascular risk factors in an adult urban population in Paraguay. Diabet Med. 1998 Apr;15(4):334-8. doi: 10.1002/(SICI)1096-9136(199804)15:43.0.CO;2-Z.'}, {'pmid': '8583468', 'type': 'BACKGROUND', 'citation': 'Ramirez MO, Pino CT, Furiasse LV, Lee AJ, Fowkes FG. Paraguayan National Blood Pressure Study: prevalence of hypertension in the general population. J Hum Hypertens. 1995 Nov;9(11):891-7.'}], 'seeAlsoLinks': [{'url': 'http://www.asuriesgo.de', 'label': 'Internet site of the study'}]}, 'descriptionModule': {'briefSummary': 'According to WHO estimations, cardiovascular diseases (CVDs) are the number one cause of death globally. More people die annually from CVDs than from any other cause. An estimated 17.5 million people died from CVDs in 2005, representing 30% of all global deaths. Of these deaths, an estimated 7.6 million were due to coronary heart disease and 5.7 million were due to stroke.\n\nOver 80% of CVD deaths take place in low- and middle-income countries and occur almost equally in men and women. In Paraguay, prevalence of classic risk factors, as well as new ones, like the metabolic syndrome are not completely known.\n\nGovernment health policies in industrialized countries are focusing on programs to modify cardiovascular risk factors. In developing countries, prevention of coronary heart disease and stroke through modification of cardiovascular risk factors are not playing a large role at the moment.\n\nThe aim of this study is to define the effects of changes in lifestyle on cardiovascular risk factors, when added to optimized standard pharmacological therapy for arterial hypertension, diabetes mellitus and hyperlipidemia, in an ambulatory urban patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'unselected outpatient population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all ambulatory patients, with age 18 years or older\n\nExclusion Criteria:\n\n* no exclusion criteria provided, particularly for the first, epidemiological part of the study'}, 'identificationModule': {'nctId': 'NCT00486993', 'acronym': 'AsuRiesgo', 'briefTitle': 'Cardiovascular Risk Factors in an Ambulatory Urban Patient Population', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Estimation of Prevalence and Assessment of the Effects of Modification of Cardiovascular Risk Factors in an Ambulatory Urban Patient Population', 'orgStudyIdInfo': {'id': 'AsuRiesgo'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'asuriesgo', 'description': 'unselected outpatient population', 'interventionNames': ['Behavioral: Dietary and nutritional modification', 'Behavioral: Stop smoking', 'Behavioral: Regular physical activities', 'Behavioral: Weight reduction to normal ranges', 'Behavioral: Regular intake of polyphenols, esp. from Ilex paraguayensis']}], 'interventions': [{'name': 'Dietary and nutritional modification', 'type': 'BEHAVIORAL', 'armGroupLabels': ['asuriesgo']}, {'name': 'Stop smoking', 'type': 'BEHAVIORAL', 'armGroupLabels': ['asuriesgo']}, {'name': 'Regular physical activities', 'type': 'BEHAVIORAL', 'armGroupLabels': ['asuriesgo']}, {'name': 'Weight reduction to normal ranges', 'type': 'BEHAVIORAL', 'armGroupLabels': ['asuriesgo']}, {'name': 'Regular intake of polyphenols, esp. from Ilex paraguayensis', 'type': 'BEHAVIORAL', 'armGroupLabels': ['asuriesgo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1749', 'city': 'Asunción', 'state': 'Dep. Central', 'country': 'Paraguay', 'facility': 'Hospital Central Instituto de Prevision Social', 'geoPoint': {'lat': -25.28646, 'lon': -57.647}}], 'overallOfficials': [{'name': 'Derliz Mereles, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heidelberg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Echocardiography Laboratory', 'investigatorFullName': 'Derliz Mereles', 'investigatorAffiliation': 'Heidelberg University'}}}}