Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:26 AM
Study NCT ID:
NCT07464704
Status:
RECRUITING
Last Update Posted:
2026-03-20
First Post:
2025-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infrasensor for Early Detection of a High-grade Obstructive NSTE-ACS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2025-12-17', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '30-day major adverse cardiovascular events (MACE) in patients without angiography', 'timeFrame': '30 days after ED presentation', 'description': 'Assessment of 30-day clinical outcomes (MACE) in participants who underwent Infrasensor measurement but did not receive invasive coronary angiography, to explore the association between Infrasensor results and short-term clinical outcomes.'}, {'measure': 'Infrasensor performance by Monk Skin Tone (MST)', 'timeFrame': 'Baseline (ED presentation) through hospital discharge, up to 30 days', 'description': 'Subgroup analysis of Infrasensor diagnostic performance stratified by Monk Skin Tone pigmentation classifications collected for all participants.'}], 'primaryOutcomes': [{'measure': 'Diagnostic performance of the Infrasensor for detection of high-grade obstructive NSTE-ACS', 'timeFrame': 'Baseline (ED presentation) through hospital discharge, up to 30 days', 'description': 'Sensitivity and specificity (with lower bound of the two-sided 95% confidence interval) of the Infrasensor for identification of high-grade obstructive non-ST-segment elevation acute coronary syndrome (NSTE-ACS), compared with angiographic diagnosis of high-grade obstructive coronary artery disease (CAD). High-grade obstructive CAD is defined as \\>50% stenosis in the left main coronary artery or \\>70% stenosis in one or more major coronary arteries and/or revascularization.'}], 'secondaryOutcomes': [{'measure': 'Additional diagnostic performance metrics of the Infrasensor', 'timeFrame': 'Baseline (ED presentation) through hospital discharge, up to 30 days', 'description': 'Positive predictive value (PPV), negative predictive value (NPV), and overall accuracy of the Infrasensor for detection of high-grade obstructive NSTE-ACS compared with angiographic diagnosis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Grade Obstructive NSTE-ACS']}, 'descriptionModule': {'briefSummary': "The objective of this prospective, cross-sectional, multicenter pivotal trial study is to validate Infrasensor's clinical performance for the detection of high grade obstructive NSTE-ACS. High-grade obstructive NSTE-ACS is defined as an acute coronary syndrome in which severe obstructive coronary artery disease, including total coronary artery occlusion is present.\n\nStudy Endpoints Primary Endpoint: Infrasensor performance (Lower bound of 95% CI for sensitivity, specificity) between device detection of high-grade obstructive NSTE-ACS and angiographic diagnosis of High-grade obstructive CAD defined as the aggregate of \\>50% left main stenosis, or \\>70% stenosis in 1 or more coronary arteries and/or emergent revascularization.\n\nSecondary Endpoint: Infrasensor performance (positive and negative predictive values, and overall accuracy)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be consecutive enrollment up to 350 patients presenting to the Emergency Department undergoing evaluation for an acute coronary syndrome in whom invasive coronary angiogram is also intended.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed Informed Consent\n* Age: ≥18 years\n* Symptomatic patients undergoing evaluation for suspected acute coronary syndrome, defined as symptoms lasting \\>20 minutes, and who present to a healthcare facility within 24 hours after symptom onset.\n* Included study subjects are those with HEART risk score \\> 4, and for whom CT angiography or invasive coronary angiography is intended.\n* The Infrasensor should only be used in alert patients who are able to keep the device still for the 5-minute measurement duration, who have clean, intact skin at the measurement site, and who do not have blood pressure cuffs, IV lines, or other medical equipment on the arm used for measurement.\n\nExclusion Criteria:\n\n* Inclusion criteria:\n\nSigned Informed Consent Age: ≥18 years Symptomatic patients undergoing evaluation for suspected acute coronary syndrome, defined as symptoms lasting \\>20 minutes, and who present to a healthcare facility within 24 hours after symptom onset.\n\nIncluded study subjects are those with HEART risk score \\> 4, and for whom CT angiography or invasive coronary angiography is intended.\n\nThe Infrasensor should only be used in alert patients who are able to keep the device still for the 5-minute measurement duration, who have clean, intact skin at the measurement site, and who do not have blood pressure cuffs, IV lines, or other medical equipment on the arm used for measurement.\n\nExclusion criteria:\n\n* Patients with scars, open wounds, or lesions that may interfere with the Infrasensor application\n* Patients triaged directly with STEMI or for cardiac reasons other than suspected AMI requiring immediate medical intervention (aortic dissection, unstable cardiac arrhythmias, left bundle branch blocks)\n* Patients in whom an obvious alternative diagnosis is suspected at the time of arrival to hospital and without suspicion of ACS (ischemic cardiomyopathy, pulmonary hypertension, chronic total occlusion)\n* Patients with acute myocardial infarction, percutaneous coronary intervention (including coronary stent placement), and/or coronary artery bypass graft surgery within the past 30 days\n* Patients with unstable angina, hospitalization for acute coronary syndrome, or hemodynamic instability (e.g., cardiogenic shock, malignant arrhythmias) within the past 30 days\n* Patients with planned coronary revascularization procedures (PCI or CABG) during the study period\n* Hemodynamically unstable patients as defined by institution's protocol\n* Exsanguination patients\n* Trauma patients"}, 'identificationModule': {'nctId': 'NCT07464704', 'briefTitle': 'Infrasensor for Early Detection of a High-grade Obstructive NSTE-ACS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Remote Cardiac Enablement'}, 'officialTitle': 'Infrasensor for Early Identification of High-grade Obstructive Non-ST-segment Elevation Acute Coronary Syndrome in Patients With Suspected Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'RCE_MS_005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'symptomatic patients undergoing a hospital-based evaluation for ACS', 'description': 'patients presenting to acute care settings, such as Emergency Departments (ED), with symptoms suggestive of an acute coronary syndrome (ACS)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chui Ong', 'role': 'CONTACT', 'email': 'chuimei.ong@ucsf.edu'}, {'name': 'Alan Wu, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelly Keene, BSN', 'role': 'CONTACT', 'email': 'kelly.keene@bcm.edu', 'phone': '713-873-9818'}, {'name': 'Zubaid Rafique, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Atandra CEO', 'role': 'CONTACT', 'email': 'atandra@rce.ai', 'phone': '408-796-9709'}], 'overallOfficials': [{'name': 'Sanjeev Bhavnani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Remote Cardiac Enablement'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared. The study includes detailed clinical, procedural, and imaging data collected to support regulatory evaluation of a proprietary investigational medical device. Due to confidentiality obligations, protection of participant privacy, and the absence of a pre-specified data-sharing plan, individual participant-level data will not be made publicly available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Remote Cardiac Enablement', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}