Arterial compliance and response to intra-aortic balloon counterpulsation in cardiogenic shock
Arterial Compliance as a Predictor of Clinical Outcomes With Intra-aortic Balloon Counterpulsation: A Prospective Observational Pilot Study
This project will see if baseline arterial compliance (stroke volume/pulse pressure) predicts which adults in cardiogenic shock benefit from intra-aortic balloon counterpulsation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07402018 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll adults with cardiogenic shock who are receiving clinically indicated intra-aortic balloon counterpulsation (IABC) and will record baseline hemodynamics from a right heart catheterization before IABC insertion. Patients will be stratified by arterial compliance (stroke volume/pulse pressure) and undergo repeat hemodynamic measurements at about 30 minutes, 3–6 hours, and 24 hours after IABC placement, with continued follow-up until the IABC course ends. The investigators will compare changes in cardiac output and filling pressures between low-compliance and normal-compliance groups and seek a compliance cutoff for future trials. Data collection is integrated with usual clinical care and is intended to inform selection of patients for IABC.
Who should consider this trial
Good fit: Adults (≥18 years) with cardiogenic shock who are undergoing intra-aortic balloon counterpulsation as part of their clinical care and can provide consent (or have a proxy provide consent).
Not a fit: Patients under 18, those not receiving IABC, those unable to consent with no available proxy, or patients who require immediate alternative mechanical support are not eligible and would not directly benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help clinicians choose which cardiogenic shock patients are most likely to improve with IABC and avoid ineffective device use.
How similar studies have performed: The concept is relatively novel: small prior physiologic studies suggest arterial compliance affects hemodynamic response, but large prospective data linking compliance to clinical IABC outcomes are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Age \<18 years old * Unable to consent or does not have power of attorney or next of kin to consent
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Matthew S Delfiner, DO, MS — Thomas Jefferson University
- Study coordinator: Elizabeth R Westburg, MS
- Email: elizabeth.westburg@jefferson.edu
- Phone: 215-955-2050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.