Intra-aortic Balloon Counterpulsation (IABC) Compliance

NCT07402018 | Recruiting

• 1 other identifier: 2025-0678
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiogenic Shock; IABC Procedure; Intraaortic Balloon Counterpulsation (IABC)

Keywords

Cardiogenic shock

Outcome Measures

Primary Outcomes (1)

• Cardiac Output (L/min)

  24 hours

Secondary Outcomes (72)

• Systolic Blood Pressure (mmHg)

  30 minutes

• Pulmonary Artery Oxygen Saturation (%)

  24 hours

• Ultimate Disposition

  Longitudinal Follow-Up (approximately 3 months)

• Total Bilirubin (mg/dL)

  24 hours

• ALT (U/L)

  24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cardiogenic shock patients undergoing Intra-aortic Balloon Counterpulsation

You may qualify if:

• Age ≥18 years old
• Cardiogenic shock
• Undergoing Intra-aortic Balloon Counterpulsation (IABC) as part of clinical care
• Able to provide consent or have power of attorney or next of kin provide consent

You may not qualify if:

• Age \<18 years old
• Unable to consent or does not have power of attorney or next of kin to consent

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Matthew S Delfiner, DO, MS

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth R Westburg, MS

CONTACT

215-955-2050; elizabeth.westburg@jefferson.edu

Matthew S Delfiner, DO, MS

CONTACT

215-955-2050

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator: Matthew S Delfiner DO, MS

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: February 11, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 11, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)