Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-03-09 @ 12:20 AM
Study NCT ID:
NCT02440893
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2015-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding the Effect of Metformin on Corus CAD (or ASGES)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'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'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2015-05-06', 'studyFirstSubmitQcDate': '2015-05-07', 'lastUpdatePostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metformin effect on Corus CAD', 'timeFrame': '7 days (+7days)', 'description': 'Observe the effect of metformin use on Corus CAD (age, sex, gene expression score - ASGES) results'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Corus CAD', 'ASGES', 'Age/Sex/Gene Expression Score', 'Gene Expression', 'GES', 'CAD', 'CVD', 'CHD', 'Precision Medicine', 'Coronary Artery Disease', 'Angina Pectoris', 'Chest Pain', 'Cardiovascular Disease', 'Coronary Heart Disease', 'Metformin'], 'conditions': ['Coronary Artery Disease', 'Angina Pectoris', 'Chest Pain', 'Cardiovascular Diseases', 'Coronary Heart Disease', 'CAD', 'CVD', 'CHD']}, 'descriptionModule': {'briefSummary': 'The study goal was to understand the effect of Metformin on Age/Sex/Gene Expression Score (ASGES) or Corus CAD (henceforth "Corus") in pre-diabetic patients who are medication naive. This study provided data to determine if the Corus CAD (ASGES) signature was different in pre-diabetic patients when metformin was newly prescribed and taken.', 'detailedDescription': 'The study goal was to understand the effect of Metformin on Age/Sex/Gene Expression Score (ASGES) or Corus CAD in pre-diabetic patients who are medication naive. This study provided data to determine if the Corus CAD (ASGES) signature was different in pre-diabetic patients when metformin was newly prescribed and taken. The primary aim of this study was to evaluate whether metformin used in pre-diabetic patients to prevent progression to type II diabetes had a significant effect on the gene expression levels measured in Corus. This was a prospective study. Subjects were enrolled from participating sites as applicable inclusion/exclusion criteria were met. The study aimed to enroll approximately fifty (50) patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be enrolled from participating sites as applicable inclusion/exclusion criteria are met. The study aims to enroll approximately fifty (50) patients.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAt least 21 years of age\n\nAny of the following:\n\n* Chest pain syndrome, stable angina, or anginal equivalent suggesting myocardial ischemia\n* Low-risk unstable angina, or\n* Asymptomatic individuals with a high probability of CAD\n\nClinician diagnosis of pre-diabetes, per ADA guidelines, such that metformin therapy is prescribed:\n\n* HgA1C: \\>5.7% - \\<6.4%,\n* BMI\\> 35 kg/m2\n* Age\\< 60 yrs\n* Prior Gestational Diabetes Mellitus\n* FPG: \\>100mg/dl - \\<126mg/dl\n* OGTT: \\>140mg/dl - \\<200mg/dl Willingness to comply with metformin therapy, for at least seven (7) days (P.O., per physician's dosage discretion) Willingness to maintain a drug diary for duration of study, for full follow-up period (7 + 7 days) Willingness and ability to provide two (2) samples for Corus (baseline, 7 (+ 7) days post- medication start) Provide written informed consent\n\nExclusion Criteria:\n\n* History of or current level of HbA1C \\>6.5\n* History of or current prescription of metformin or any other diabetic medication\n* History of myocardial infarction (MI) or prior revascularization\n* Current MI or acute coronary syndrome (ACS)\n* Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms\n* Current systemic infectious or systemic inflammatory conditions\n* Subjects currently taking steroids, immunosuppressive agents or chemotherapeutic agents"}, 'identificationModule': {'nctId': 'NCT02440893', 'acronym': 'MET', 'briefTitle': 'Understanding the Effect of Metformin on Corus CAD (or ASGES)', 'organization': {'class': 'INDUSTRY', 'fullName': 'CardioDx'}, 'officialTitle': 'Understanding the Effect of Metformin on Corus CAD (MET Study)', 'orgStudyIdInfo': {'id': 'CDX_000018'}, 'secondaryIdInfos': [{'id': 'MET Study', 'type': 'OTHER', 'domain': 'CardioDx'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Corus CAD (ASGES) Post-metformin', 'description': 'Corus CAD (ASGES) second sample draw results to compare to Corus CAD (ASGES) first draw results (per patient).', 'interventionNames': ['Diagnostic Test: Corus CAD (ASGES)']}], 'interventions': [{'name': 'Corus CAD (ASGES)', 'type': 'DIAGNOSTIC_TEST', 'armGroupLabels': ['Corus CAD (ASGES) Post-metformin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mark Mouton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Mouton Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CardioDx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}