Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT01677156
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2012-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (or ASGES) in Primary Care Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D000787', 'term': 'Angina Pectoris'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 713}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2012-08-29', 'studyFirstSubmitQcDate': '2012-08-29', 'lastUpdatePostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe referral patterns for cardiac care and testing within 1 month after gene expression testing.', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'To describe follow up events (eg., diagnoses, non-cardiac testing, medication use, MACE) at 12 months follow up within ASGES (age, sex,gene expression score) test strata.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ASGES', 'Corus CAD', 'Age/Sex/Gene Expression Score', 'Gene Expression', 'GES', 'CAD', 'CVD', 'CHD', 'Precision Medicine', 'Clinical Utility', 'Registry', 'Coronary Artery Disease', 'Angina Pectoris', 'Chest Pain', 'Cardiovascular Disease', 'Coronary Heart Disease', 'PRESET'], 'conditions': ['Chest Pain', 'Coronary Artery Disease', 'Cardiovascular Diseases', 'Coronary Heart Disease', 'Angina Pectoris', 'CAD', 'CVD', 'CHD']}, 'referencesModule': {'references': [{'pmid': '27993573', 'type': 'BACKGROUND', 'citation': 'Ladapo JA, Budoff M, Sharp D, Zapien M, Huang L, Maniet B, Herman L, Monane M. Clinical Utility of a Precision Medicine Test Evaluating Outpatients with Suspected Obstructive Coronary Artery Disease. Am J Med. 2017 Apr;130(4):482.e11-482.e17. doi: 10.1016/j.amjmed.2016.11.021. Epub 2016 Dec 16.'}, {'pmid': '29210056', 'type': 'DERIVED', 'citation': 'Ladapo JA, Budoff MJ, Sharp D, Kuo JZ, Huang L, Maniet B, Herman L, Monane M. Utility of a Precision Medicine Test in Elderly Adults with Symptoms Suggestive of Coronary Artery Disease. J Am Geriatr Soc. 2018 Feb;66(2):309-315. doi: 10.1111/jgs.15215. Epub 2017 Dec 6.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=Clinical+Utility+of+a+Precision+Medicine+Test+Evaluating+Outpatients+with+Suspected+Obstructive+Coronary+Artery+Disease', 'label': 'Am J Med. 2017 Apr;130(4):482.e11-482.e17. doi: 10.1016/j.amjmed.2016.11.021. Epub 2016 Dec 16.'}, {'url': 'http://www.amjmed.com/article/S0002-9343(16)31235-9/fulltext', 'label': 'The American Journal of Medicine (PRESET study)'}]}, 'descriptionModule': {'briefSummary': 'The PRESET Registry--A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (Age/Sex/Gene Expression score - ASGES) in Real World Clinical Care Settings (PRESET)--was designed as an observational, post-market, real-world registry to evaluate patterns of care, including referrals to a cardiologist, cardiac stress testing, CT angiography, within the first month after Corus CAD (ASGES) testing.', 'detailedDescription': 'The prospective PRESET Registry (NCT01677156) enrolled stable, nonacute adult patients presenting with typical or atypical symptoms suggestive of obstructive coronary artery disease from 21 US primary care practices from August 2012 to August 2014. Demographics, clinical characteristics, and Corus CAD (Age/Sex/Gene Expression score - ASGES) results (predefined as low \\[ASGES \\<15\\] or elevated \\[ASGES \\>15\\]) were collected, as were referrals to Cardiology or further functional/anatomic cardiac testing after Corus CAD (Age/Sex/Gene Expression score - ASGES) testing. Patients were followed for 1 year post ASGES testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients presenting to their primary clinician's office with chest pain suggestive of obstructive coronary artery disease.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Symptoms suggestive of CAD, according to the opinion of the site registry clinician\n2. Receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD\n3. Age \\>= 18 years\n4. Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n1. History of myocardial infarction (MI)\n2. Current MI or acute coronary syndrome\n3. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms\n4. Known/documented CAD\n5. Diabetes Mellitus'}, 'identificationModule': {'nctId': 'NCT01677156', 'acronym': 'PRESET', 'briefTitle': 'A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (or ASGES) in Primary Care Settings', 'organization': {'class': 'INDUSTRY', 'fullName': 'CardioDx'}, 'officialTitle': 'The PRESET Registry: A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Real World Clinical Care Settings', 'orgStudyIdInfo': {'id': 'CDX_000015'}, 'secondaryIdInfos': [{'id': 'PRESET', 'type': 'OTHER', 'domain': 'CardioDx'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Receiving Corus CAD (ASGES)', 'description': 'Patients receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD', 'interventionNames': ['Diagnostic Test: CORUS CAD (ASGES)']}], 'interventions': [{'name': 'CORUS CAD (ASGES)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Age/Sex/Gene Expression Score - ASGES', 'armGroupLabels': ['Receiving Corus CAD (ASGES)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Warner Family Practice', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '30546', 'city': 'Hiawassee', 'state': 'Georgia', 'country': 'United States', 'facility': 'Synergy Health', 'geoPoint': {'lat': 34.94926, 'lon': -83.75739}}, {'zip': '30024', 'city': 'Suwanee', 'state': 'Georgia', 'country': 'United States', 'facility': "John's Creek Primary Care", 'geoPoint': {'lat': 34.05149, 'lon': -84.0713}}, {'zip': '40353', 'city': 'Mount Sterling', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Paul McLaughlin, MD - Family Practice', 'geoPoint': {'lat': 38.05647, 'lon': -83.94326}}, {'zip': '71369', 'city': 'Simmesport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'KD Health and Wellness Center', 'geoPoint': {'lat': 30.98352, 'lon': -91.80012}}, {'zip': '68130', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Doctors for Health', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '27405', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'TIMA Wellness', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '45402', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dayton Internal Medicine', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '44505', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Northside Medical Center', 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}, {'zip': '75414', 'city': 'Bells', 'state': 'Texas', 'country': 'United States', 'facility': 'Bells Medical Clinic', 'geoPoint': {'lat': 33.61038, 'lon': -96.41082}}, {'zip': '75418', 'city': 'Bonham', 'state': 'Texas', 'country': 'United States', 'facility': 'Family Care Clinic', 'geoPoint': {'lat': 33.57733, 'lon': -96.17831}}, {'zip': '75218', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Aldrich Internal Medicine', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76054', 'city': 'Hurst', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Familicare', 'geoPoint': {'lat': 32.82346, 'lon': -97.17057}}], 'overallOfficials': [{'name': 'Michael Zapien, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CardioDx, Inc.'}, {'name': 'Mark Monane, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CardioDx, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CardioDx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}