Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-28 @ 6:37 PM
Study NCT ID:
NCT01003392
Status:
UNKNOWN
Last Update Posted:
2014-01-07
First Post:
2009-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Coffee on the Health and on the Heart of Normal, Diabetics e Coronary Artery Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-10-06', 'releaseDate': '2021-09-09'}], 'estimatedResultsFirstSubmitDate': '2021-09-09'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-06', 'studyFirstSubmitDate': '2009-10-26', 'studyFirstSubmitQcDate': '2009-10-27', 'lastUpdatePostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Verify the relationship between coffee ingestion and cardiovascular morbidity and mortality', 'timeFrame': '10 years of follow-up'}], 'secondaryOutcomes': [{'measure': 'Relationship between coffee ingestion and cardiovascular risk factors', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary artery disease', 'Coffee', 'Heart system'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Coffee is a worldwide drink, been part of any culture. There are some concerns about effects of coffee on the health. Recently, epidemiological studies have shown benefits of coffee drinking to diabetics and also to prevent diabetes in populations. We aim to understand some effects of coffee and not only caffeine over vascular system, in special coronary artery disease patients, diabetics end normal people.', 'detailedDescription': 'Patients will have a wash-out period (21 days) with no coffee or other caffeine-drinks. Then they will be submitted to treadmill test, MAPA, Holter-ECG and vascular reactivity study, biochemical and inflammatory plasma dosages, as basal. Then they will start a period of coffee drinking over 4 weeks; and all exams will be repeated. We will study two types of coffee, arabica and robusta; with two types of toasted beans(regular and soft). Also regular and decaffeinated coffee. A total of 300 (100 normal people, 100 diabetics, 100 coronary disease) individuals will be tested.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Group of normal patients, group of patients with diagnosed coronary artery disease and group of diabetic patients.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNormal Volunteers:\n\n1. Healthy volunteer.\n2. Age between 20 and 80 years.\n3. No addict to drugs.\n4. Absence of chronicle diseases.\n5. No alcohol abuse.\n6. No smoker.\n\nCoronary artery disease:\n\n1. Presence of coronary artery disease, by coronary angiography\n2. Stable angina, class 1-3 of CCS.\n3. Age between 20 and 80 years.\n4. Treadmill effort test with ischemia.\n5. No alcohol abuse.\n6. No smoker.\n\nDiabetes:\n\n1. Presence of type II Diabetes on oral treatment.\n2. Age between 20 and 80 years.\n3. Absence of chronicle diseases, except diabetes.\n4. No alcohol abuse.\n5. No smoker.\n\nExclusion Criteria:\n\nNormal Volunteers:\n\n1. Any blood test with twice or more the upper limit range.\n2. Presence of enlarged QRS.\n\nCoronary artery disease:\n\n1. Any blood test with twice or more the upper limit range even with treatment.\n2. Presence of enlarged QRS.\n3. Ventricular dysfunction (EF \\< 45%).\n\nDiabetes:\n\n1. Blood glucose greater than 160 mg/dL.\n2. Others blood tests with twice or more the upper limit range even with treatment.\n3. Presence of enlarged QRS.'}, 'identificationModule': {'nctId': 'NCT01003392', 'acronym': 'Coffee&Heart', 'briefTitle': 'Influence of Coffee on the Health and on the Heart of Normal, Diabetics e Coronary Artery Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Study of Coffee and Its Influence on the Heart in Normal People, Those With Coronary Artery Disease and Diabetics.', 'orgStudyIdInfo': {'id': 'SDC2500/04/120'}, 'secondaryIdInfos': [{'id': 'CAPPesq-879/04', 'type': 'OTHER', 'domain': 'CAPPesq'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal', 'description': 'Normal volunteers, with no diagnosed chronic disease.'}, {'label': 'Coronary artery disease', 'description': 'Group of patients with diagnosed coronary artery disease.'}, {'label': 'Diabetes', 'description': 'Diabetic patients.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403000', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Luiz A Machado Cesar, Phd, MD', 'role': 'CONTACT', 'email': 'luiz.cesar@incor.usp.br', 'phone': '551130695387'}, {'name': 'Bruno M Mioto, MD', 'role': 'CONTACT', 'email': 'brunomioto@gmail.com', 'phone': '551130695437'}, {'name': 'Bruno M Mioto, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Miguel A Moretti, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daniela Taratsouchi, nutricionist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Reynaldo V Amato, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Vera Lucia Tuda, Nurse', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Heart Institute (InCor), Univ. of Sao Paulo Medical School', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Luiz A Machado Cesar, PhD, MD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Heart Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Feculdade de Medicina da Universidade de Sao Paulo - Brasil', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Luiz Antonio M. Cesar', 'investigatorAffiliation': 'University of Sao Paulo'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-09-09', 'type': 'RELEASE'}, {'date': '2021-10-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Luiz Antonio M. Cesar, Professor of Medicine, University of Sao Paulo'}}}}