Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT00403351
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2006-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alternative Risk Markers in Coronary Artery Disease (ARMCAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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_WITHOUT_DNA', 'description': 'Serum specifically for future cardiac biomarkers'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 665}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2006-11-22', 'studyFirstSubmitQcDate': '2006-11-22', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Other cardiovascular events or procedures', 'timeFrame': '1, 2, 5 years'}], 'primaryOutcomes': [{'measure': 'Extent and severity of angiographic coronary artery disease', 'timeFrame': 'cross-sectional'}, {'measure': 'All-cause death or myocardial infarction', 'timeFrame': '1, 2, 5 years'}, {'measure': 'All-cause death, MI or need for cardiac surgery', 'timeFrame': '1, 2, 5 years'}], 'secondaryOutcomes': [{'measure': 'All-cause death', 'timeFrame': '1, 2, 5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Risk', 'Coronary artery disease', 'Heart Rate variability', 'Pulse wave analysis', 'BNP', 'CRP'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '19858725', 'type': 'RESULT', 'citation': 'Kotecha D, Flather M, McGrady M, Pepper J, New G, Krum H, Eccleston D. Contemporary predictors of coronary artery disease in patients referred for angiography. Eur J Cardiovasc Prev Rehabil. 2010 Jun;17(3):280-8. doi: 10.1097/HJR.0b013e3283310108.'}, {'pmid': '22121069', 'type': 'RESULT', 'citation': 'Kotecha D, New G, Flather MD, Eccleston D, Pepper J, Krum H. Five-minute heart rate variability can predict obstructive angiographic coronary disease. Heart. 2012 Mar;98(5):395-401. doi: 10.1136/heartjnl-2011-300033. Epub 2011 Nov 25.'}, {'pmid': '22483418', 'type': 'RESULT', 'citation': 'Kotecha D, New G, Collins P, Eccleston D, Krum H, Pepper J, Flather MD. Radial artery pulse wave analysis for non-invasive assessment of coronary artery disease. Int J Cardiol. 2013 Aug 10;167(3):917-24. doi: 10.1016/j.ijcard.2012.03.098. Epub 2012 Apr 4.'}, {'pmid': '30943979', 'type': 'DERIVED', 'citation': 'Kotecha D, Flather MD, Atar D, Collins P, Pepper J, Jenkins E, Reid CM, Eccleston D; Alternative Risk Markers in Coronary Artery Disease (ARM-CAD) Study. B-type natriuretic peptide trumps other prognostic markers in patients assessed for coronary disease. BMC Med. 2019 Apr 3;17(1):72. doi: 10.1186/s12916-019-1306-9.'}], 'seeAlsoLinks': [{'url': 'http://www.armcad.com', 'label': 'Study website'}]}, 'descriptionModule': {'briefSummary': 'Estimating the risk of future cardiovascular events such as death, stroke and myocardial infarction using traditional risk factors (such as age, gender, smoking, diabetes, hyperlipidaemia and hypertension) is well accepted in patients with and without existing cardiovascular disease. These estimates are based on a number of robust observational studies, including the original Framingham study. While these methods apply reasonably well on a population level their application to the individual patients is not always straightforward. In addition, risk charts, such as those published by the Joint British Societies and American Heart Association, may underestimate risk in certain groups, notably diabetics and patients of Indo-Asian background, whilst overestimating risk in others (by as much as 50% in some studies).', 'detailedDescription': 'A number of variables including clinical, biochemical, and enzymatic have been evaluated to see if they add to conventional "risk-reduction" models such as Framingham and if so, to understand if they may be used in routine clinical practice.\n\nThe aim of this study is to assess several known and a few novel risk-factors (heart rate variability, pulse wave analysis, high-sensitivity CRP and BNP) prior to planned elective coronary angiography (cross-sectional analysis) and in a prospective cohort of high and low-risk patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ARM-CAD 1: Patients attending elective coronary angiography ARM-CAD 2: Participants in ARM-CAD 1 plus volunteers with cardiac risk factors', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18 years or older)\n* Male or Female\n\nExclusion Criteria:\n\n* Acute coronary syndrome\n* Urgent angiography\n* Assessment would constitute harm to patient\n* Informed consent not obtained'}, 'identificationModule': {'nctId': 'NCT00403351', 'briefTitle': 'Alternative Risk Markers in Coronary Artery Disease (ARMCAD)', 'organization': {'class': 'OTHER', 'fullName': 'Monash University'}, 'officialTitle': 'Correlation of Multiple Risk Factors With Presence and Severity of Coronary Artery Disease.', 'orgStudyIdInfo': {'id': 'CP-02/04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ARM-CAD 1', 'description': 'Cross-sectional analysis using coronary angiogram results'}, {'label': 'ARM-CAD 2', 'description': 'Prospective cohort for incident cardiovascular events and mortality'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3128', 'city': 'Box Hill', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Box Hill Hospital (Eastern Health)', 'geoPoint': {'lat': -37.81887, 'lon': 145.12545}}, {'city': 'Caulfield', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Caulfield General Medical Centre', 'geoPoint': {'lat': -37.88251, 'lon': 145.02288}}, {'zip': '3076', 'city': 'Epping', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Northern Hospital (Northern Health)', 'geoPoint': {'lat': -37.65, 'lon': 145.03333}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Dipak Kotecha, MB ChB PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University, Royal Brompton Hospital & University of Birmingham'}, {'name': 'David Eccleston, MBBS FRACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University and Northern Hospital'}, {'name': 'Henry Krum, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alfred Hospital / Monash University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monash University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Royal Brompton & Harefield NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'IM Medical Ltd, Melbourne', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'Ingrid Hopper', 'investigatorAffiliation': 'Monash University'}}}}