Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:41 AM
Study NCT ID:
NCT07402018
Status:
RECRUITING
Last Update Posted:
2026-02-11
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-aortic Balloon Counterpulsation (IABC) Compliance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-06', 'studyFirstSubmitDate': '2026-01-09', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Output (L/min)', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Systolic Blood Pressure (mmHg)', 'timeFrame': '30 minutes'}, {'measure': 'Pulmonary Artery Oxygen Saturation (%)', 'timeFrame': '24 hours'}, {'measure': 'Ultimate Disposition', 'timeFrame': 'Longitudinal Follow-Up (approximately 3 months)', 'description': 'Hospital death'}, {'measure': 'Total Bilirubin (mg/dL)', 'timeFrame': '24 hours', 'description': 'participant laboratory value'}, {'measure': 'ALT (U/L)', 'timeFrame': '24 hours', 'description': 'participant laboratory value'}, {'measure': 'AST (U/L)', 'timeFrame': '24 hours', 'description': 'participant laboratory value'}, {'measure': 'Creatine Clearance/GFR', 'timeFrame': '24 hours'}, {'measure': 'Creatine (mg/dL)', 'timeFrame': '24 hours', 'description': 'participant laboratory value'}, {'measure': 'Lactate millimoles per liter (mmol/L)', 'timeFrame': '24 hours', 'description': 'participant laboratory value'}, {'measure': 'Pulmonary Artery Compliance (mmHg)', 'timeFrame': '24 hours'}, {'measure': 'Right Ventricular Stroke Work Index (g·m-²·beat-¹)', 'timeFrame': '24 hours'}, {'measure': 'Pulmonary Artery Pulsatility Index (PAPi)', 'timeFrame': '24 hours', 'description': 'calculated measurement'}, {'measure': 'Pulmonary Vascular Resistance (dynes/cm⁵)', 'timeFrame': '24 hours'}, {'measure': 'Systemic Vascular Resistance (mmHg/L/min)', 'timeFrame': '24 hours'}, {'measure': 'Pulmonary Capillary Wedge Pressure (mmHg)', 'timeFrame': '24 hours'}, {'measure': 'Diastolic Pulmonary Arterial Pressure (mmHg)', 'timeFrame': '24 hours'}, {'measure': 'Systolic Pulmonary Artery Pressure (mmHg)', 'timeFrame': '24 hours'}, {'measure': 'Right Atrium Pressure (mmHg)', 'timeFrame': '24 hours', 'description': 'report measurement'}, {'measure': 'Aortic Pulsatility Index (API)', 'timeFrame': '24 hours', 'description': 'calculated measurement'}, {'measure': 'Cardiac Power Input (W/m²)', 'timeFrame': '24 hours'}, {'measure': 'Cardiac Power Output (Watts)', 'timeFrame': '24 hours'}, {'measure': 'Stroke Volume (mL)', 'timeFrame': '24 hours'}, {'measure': 'Cardiac Index (L/min/m²)', 'timeFrame': '24 hours'}, {'measure': 'Heart Rhythm', 'timeFrame': '24 hours', 'description': 'Normal Sinus Rhythm, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation, Ventricular Tachycardia, Sinus Bradycardia, Sinus Tachycardia, other'}, {'measure': 'Heart Rate (beats per minute)', 'timeFrame': '24 hours'}, {'measure': 'Mean Arterial Pressure (mmHg)', 'timeFrame': '24 hours'}, {'measure': 'Diastolic Blood Pressure (mmHg)', 'timeFrame': '24 hours'}, {'measure': 'Systolic Blood Pressure (mmHg)', 'timeFrame': '24 hours'}, {'measure': 'Pulmonary Artery Compliance (mmHg)', 'timeFrame': '3-6 hours'}, {'measure': 'Right Ventricular Stroke Work Index (g·m-²·beat-¹)', 'timeFrame': '3-6 hours'}, {'measure': 'Pulmonary Artery Pulsatility Index (PAPi)', 'timeFrame': '3-6 hours', 'description': 'calculated measurement'}, {'measure': 'Pulmonary Vascular Resistance (dynes/cm⁵)', 'timeFrame': '3-6 hours'}, {'measure': 'Systemic Vascular Resistance (mmHg/L/min)', 'timeFrame': '3-6 hours'}, {'measure': 'Pulmonary Capillary Wedge Pressure (mmHg)', 'timeFrame': '3-6 hours'}, {'measure': 'Diastolic Pulmonary Arterial Pressure (mmHg)', 'timeFrame': '3-6 hours'}, {'measure': 'Systolic Pulmonary Artery Pressure (mmHg)', 'timeFrame': '3-6 hours'}, {'measure': 'Right Atrium Pressure (mmHg)', 'timeFrame': '3-6 hours', 'description': 'report measurement'}, {'measure': 'Aortic Pulsatility Index (API)', 'timeFrame': '3-6 hours', 'description': 'calculated measurement'}, {'measure': 'Cardiac Power Input (W/m²)', 'timeFrame': '3-6 hours'}, {'measure': 'Cardiac Power Output (Watts)', 'timeFrame': '3-6 hours'}, {'measure': 'Stroke Volume (mL)', 'timeFrame': '3-6 hours'}, {'measure': 'Cardiac Index (L/min/m²)', 'timeFrame': '3-6 hours'}, {'measure': 'Cardiac Output (L/min)', 'timeFrame': '3-6 hours'}, {'measure': 'Pulmonary Artery Oxygen Saturation (%)', 'timeFrame': '3-6 hours'}, {'measure': 'Heart Rhythm', 'timeFrame': '3-6 hours', 'description': 'Normal Sinus Rhythm, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation, Ventricular Tachycardia, Sinus Bradycardia, Sinus Tachycardia, other'}, {'measure': 'Heart Rate (beats per minute)', 'timeFrame': '3-6 hours'}, {'measure': 'Mean Arterial Pressure (mmHg)', 'timeFrame': '3-6 hours'}, {'measure': 'Diastolic Blood Pressure (mmHg)', 'timeFrame': '3-6 hours'}, {'measure': 'Systolic Blood Pressure (mmHg)', 'timeFrame': '3-6 hours'}, {'measure': 'Pulmonary Artery Compliance (mmHg)', 'timeFrame': '30 minutes'}, {'measure': 'Right Ventricular Stroke Work Index (g·m-²·beat-¹)', 'timeFrame': '30 minutes'}, {'measure': 'Pulmonary Artery Pulsatility Index (PAPi)', 'timeFrame': '30 minutes', 'description': 'calculated measurement'}, {'measure': 'Pulmonary Vascular Resistance (dynes/cm⁵)', 'timeFrame': '30 minutes'}, {'measure': 'Systemic Vascular Resistance (mmHg/L/min)', 'timeFrame': '30 minutes'}, {'measure': 'Pulmonary Capillary Wedge Pressure (mmHg)', 'timeFrame': '30 minutes'}, {'measure': 'Diastolic Pulmonary Arterial Pressure (mmHg)', 'timeFrame': '30 minutes'}, {'measure': 'Systolic Pulmonary Artery Pressure (mmHg)', 'timeFrame': '30 minutes'}, {'measure': 'Right Atrium Pressure (mmHg)', 'timeFrame': '30 minutes', 'description': 'report measurement'}, {'measure': 'Aortic Pulsatility Index (API)', 'timeFrame': '30 minutes', 'description': 'calculated measurement'}, {'measure': 'Cardiac Power Input (W/m²)', 'timeFrame': '30 minutes'}, {'measure': 'Stroke Volume (mL)', 'timeFrame': '30 minutes'}, {'measure': 'Cardiac Power Output (Watts)', 'timeFrame': '30 minutes'}, {'measure': 'Cardiac Index (L/min/m²)', 'timeFrame': '30 minutes'}, {'measure': 'Cardiac Output (L/min)', 'timeFrame': '30 minutes'}, {'measure': 'Pulmonary Artery Oxygen Saturation (%)', 'timeFrame': '30 minutes'}, {'measure': 'Heart Rhythm', 'timeFrame': '30 minutes', 'description': 'Normal Sinus Rhythm, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation, Ventricular Tachycardia, Sinus Bradycardia, Sinus Tachycardia, other'}, {'measure': 'Heart Rate (beats per minute)', 'timeFrame': '30 minutes'}, {'measure': 'Mean Arterial Pressure (mmHg)', 'timeFrame': '30 minutes'}, {'measure': 'Diastolic Blood Pressure (mmHg)', 'timeFrame': '30 minutes'}, {'measure': 'Ultimate Disposition', 'timeFrame': 'Longitudinal Follow-Up (approximately 3 months)', 'description': 'Heart recovery with discharge (alive)'}, {'measure': 'Ultimate Disposition', 'timeFrame': 'Longitudinal Follow-Up (approximately 3 months)', 'description': 'Left Ventricular Assist Device (LVAD)'}, {'measure': 'Ultimate Disposition', 'timeFrame': 'Longitudinal Follow-Up (approximately 3 months)', 'description': 'Transplant'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiogenic shock'], 'conditions': ['Cardiogenic Shock', 'IABC Procedure', 'Intraaortic Balloon Counterpulsation (IABC)']}, 'descriptionModule': {'briefSummary': 'The investigators intend to study how baseline arterial compliance (as defined by stroke volume/pulse pressure) influences the clinical success of intraaortic balloon counterpulsation (IABC) in patients with cardiogenic shock (CS). The investigators aim to compare clinical outcomes in CS patients requiring IABC with normal compliance versus low compliance. The study will enroll patients undergoing IABC that are clinically indicated. Baseline hemodynamic measurements will be obtained and then patients would be stratified based on their compliance. Post IABC, serial hemodynamic measurements will be obtained and compared between groups. Patients will continue to be followed longitudinally until the IABC has been discontinued for any reason. The proposed study will yield results that will aid in developing a larger clinical trial and ultimately assist clinicians in determining if IABC is appropriate therapy for patients in cardiogenic shock.', 'detailedDescription': 'This study will focus on patients in cardiogenic shock (CS) that will be undergoing clinically indicated intraaortic balloon counterpulsation (IABC) insertion and right heart catheterization. Prior to IABC insertion a patient will have their clinically indicated right heart catheterization. The investigators will record these baseline hemodynamic parameters, including (but not limited to) stroke volume and arterial pulse pressure.\n\nAfter IABC insertion is completed, repeat hemodynamic measurements will be obtained approximately 30 minutes later. Repeat hemodynamic measurements will be recorded at approximately 3-6 hours following the procedure, and 24 hours following the procedure. The act of recording hemodynamic measurements is part of the usual clinical management of patients with IABC.\n\nThe patients will continue be followed longitudinally until their IABC course has completed, either due to resolution of CS, exchange for a separate device, heart transplantation, durable Left Ventricular Assist Device (LVAD) implant, or patient death.\n\nThe investigators hypothesize that patients with low arterial compliance will have greater improvements in cardiac output and cardiac filling pressures compared to patients with normal compliance. The specific aims are to (1) compare hemodynamic changes with IABC in cardiogenic shock patients with low compliance vs those with normal compliance and (2) to determine a cutoff value of compliance that can be used for future larger clinical trials.\n\nThe proposed study will yield results that will aid in developing a larger clinical trial and ultimately assist clinicians in determining if IABC is appropriate therapy for patients in cardiogenic shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cardiogenic shock patients undergoing Intra-aortic Balloon Counterpulsation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old\n* Cardiogenic shock\n* Undergoing Intra-aortic Balloon Counterpulsation (IABC) as part of clinical care\n* Able to provide consent or have power of attorney or next of kin provide consent\n\nExclusion Criteria:\n\n* Age \\<18 years old\n* Unable to consent or does not have power of attorney or next of kin to consent'}, 'identificationModule': {'nctId': 'NCT07402018', 'briefTitle': 'Intra-aortic Balloon Counterpulsation (IABC) Compliance', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Arterial Compliance as a Predictor of Clinical Outcomes With Intra-aortic Balloon Counterpulsation: A Prospective Observational Pilot Study', 'orgStudyIdInfo': {'id': '2025-0678'}}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Westburg, MS', 'role': 'CONTACT', 'email': 'elizabeth.westburg@jefferson.edu', 'phone': '267-872-1871'}, {'name': 'Matthew S Delfiner, DO, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Elizabeth R Westburg, MS', 'role': 'CONTACT', 'email': 'elizabeth.westburg@jefferson.edu', 'phone': '215-955-2050'}, {'name': 'Matthew S Delfiner, DO, MS', 'role': 'CONTACT', 'phone': '215-955-2050'}], 'overallOfficials': [{'name': 'Matthew S Delfiner, DO, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator: Matthew S Delfiner DO, MS', 'investigatorFullName': 'Matthew Delfiner', 'investigatorAffiliation': 'Thomas Jefferson University'}}}}