Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
Study NCT ID:
NCT03551756
Status:
UNKNOWN
Last Update Posted:
2020-01-23
First Post:
2018-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-22', 'studyFirstSubmitDate': '2018-05-29', 'studyFirstSubmitQcDate': '2018-05-29', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarker assessment', 'timeFrame': '1 day', 'description': 'Exploratory biomarker analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure With Reduced Ejection Fraction', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Assessment of Biomarkers in Patients with Decompensated Heart Failure and Underlying Coronary Artery Disease', 'detailedDescription': 'This is a cross-sectional, single center exploratory study of plasma biomarker levels in adults with decompensated heart failure and significant underlying coronary artery disease as compared with age-matched healthy controls. Subjects will not receive a therapeutic treatment as part of this study and will undergo a single blood draw.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '100 subjects with the study diagnosis and 20 healthy age-matched subjects, no restrictions on gender, race, or ethnicity', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup 1: Heart Failure with Coronary Artery Disease Subjects\n\n* Symptomatic heart failure (≥ 3 months) with most recently documented LVEF ≤ 40% (Echo must have been completed in last 12 months prior to enrollment.)\n* Significant underlying coronary artery disease as evidenced by:\n* previous myocardial infarction\n* prior coronary artery bypass graft\n* 50% coronary stenosis of one or more arteries and/or\n* history of percutaneous coronary intervention with or without stenting\n* Age 18 years or older at the first screening visit\n\nGroup 2: Healthy Subjects\n\n• Age 18 years or older at the first screening visit and within 20% of mean age of Group 1 Subjects\n\nExclusion Criteria:\n\nGroup 1:\n\n* Documented history of "severe" valvular disease\n* Documented history of atrial fibrillation, ventricular fibrillation or ventricular tachycardia.\n* Recent or current use of anticoagulant medications such as fXa inhibitors, direct thrombin inhibitors, vitamin K antagonists, or heparin. (within 1 month of screening)\n\nGroup 2:\n\n* Known significant cardiovascular or hematological condition\n* Recent or current use of anticoagulant medications such as fXa inhibitors, direct thrombin inhibitors, vitamin K antagonists, or heparin. (within 1 month of screening)\n* Recent cold or flu symptoms, respiratory infection or surgery (within 2 weeks of screening)\n* History of Asthma\n* History of peptic ulcers'}, 'identificationModule': {'nctId': 'NCT03551756', 'briefTitle': 'Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'CirQuest Labs, LLC'}, 'officialTitle': 'Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'CQ 17-11-009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heart Failure & Coronary Artery Disease', 'description': 'Biomarker assessment in adults with decompensated heart failure and significant underlying coronary artery disease', 'interventionNames': ['Other: Biomarker Assessment']}, {'label': 'Healthy Adult', 'description': 'Biomarker assessment in 20 healthy age-matched subjects', 'interventionNames': ['Other: Biomarker Assessment']}], 'interventions': [{'name': 'Biomarker Assessment', 'type': 'OTHER', 'description': 'Exploratory Biomarker Analysis for cardiac patients versus healthy adults', 'armGroupLabels': ['Healthy Adult', 'Heart Failure & Coronary Artery Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Latonya Been', 'role': 'CONTACT', 'email': 'Latonya.Been@jax.ufl.edu', 'phone': '904-244-4520'}, {'name': 'Dominick J Angiolillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian Dragutsky', 'role': 'CONTACT', 'email': 'brian.dragutsky@sterncardio.com', 'phone': '901-271-1000'}, {'name': 'Rishi Bhula', 'role': 'CONTACT', 'email': 'rishi.bhula@sterncardio.com', 'phone': '901-271-1000'}, {'name': 'Frank A McGrew, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stern Cardiovascular', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '38112', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carol E Hendrix, MSN, RN', 'role': 'CONTACT', 'email': 'chendrix@cirquestlabs.com', 'phone': '901-866-1700'}, {'name': 'Edward Hord, BSN, RN', 'role': 'CONTACT', 'email': 'ehord@cirquestlabs.com', 'phone': '901-866-1700'}, {'name': 'Lisa K Jennings, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rick Alleman, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CirQuest Labs, LLC', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'centralContacts': [{'name': 'Carol E Hendrix, MSN, RN', 'role': 'CONTACT', 'email': 'chendrix@cirquestlabs.com', 'phone': '901-866-1700'}, {'name': 'Edward Hord, BSN, RN', 'role': 'CONTACT', 'email': 'ehord@cirquestlabs.com', 'phone': '901-866-1700'}], 'overallOfficials': [{'name': 'Lisa K. Jennings, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CirQuest Labs, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CirQuest Labs, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}