Pressure-Volume Loop During High-Risk PCI

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT04681313
• Lead Sponsor: Henry Ford Health System

Brief Summary

This study will examine the physiologic effects on loading conditions and contractility of the left ventricle during high-risk primary coronary intervention (HRPCI) in the Cardiac Cath Lab.

This will be performed through analysis of real-time left ventricular (LV) pressure-volume loops (PVL) by continuously recording PVL during HRPCI with the Inca® Pressure-Volume Loop System that will be temporarily placed in the left ventricle during the procedure.

Detailed Description

Given the complexity of patients treated by high risk percutaneous coronary interventions (HRPCI), mechanical circulatory support (MCS) devices are increasingly used to maintain hemodynamic stability during these procedures. It is crucial to have a better understanding of the hemodynamic effects during HRPCI and of MCS devices to guide appropriate device selection and utilization for HRPCI.

Clinical studies evaluating different MCS devices are not all consistent in terms of patient selection, outcomes examined and overall findings. Therefore, the role of MCS devices in HRPCI is still widely debated. This is reflected in a variable clinical practice pattern and recommendations from professional society guidelines. The investigators believe that having a clear scientific understanding of MCS devices in terms of hemodynamic effects during different stages of these complex procedures may prove helpful in refining the process of appropriate MCS device selection in appropriate clinical setting.

One especially insightful method of examining the MCS devices effect is analyzing the left ventricular (LV) pressure-volume loops (PVL). Continuously recording PVL during HRPCI can provide valuable data on the device effects on loading conditions and contractility of the left ventricle.

In this study, the investigators will collect hemodynamic data in real-time during HRPCI being performed as standard of care and continuously recording left ventricular pressure-volume loop (PVL) throughout the procedure via the Inca® Pressure-Volume Loop System (CD Leycom, Hengelo, The Netherlands).

Study Timeline

• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-23
• Study Start: 2021-04-19
• Primary Completion: 2022-12-01
• Study Completion: 2024-09-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Adult patients (18 years and older) with known coronary artery disease and planned elective HRPCI procedures.

Exclusion Criteria

• Any patient not considered appropriate for elective HRPCI procedures.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in left ventricular end diastolic pressure (LVEDP).	Immediate (during PCI).	Measured changes in left ventricular end diastolic pressure (LVEDP) as measured real-time by the Inca PV-Loop system.
Changes in left ventricular end systolic pressure.	Immediate (during PCI).	Measured changes in left ventricular end systolic pressure as measured real-time by the Inca PV-Loop system.
Changes in left ventricular compliance.	Immediate (during PCI).	Measured changes in left ventricular compliance as measured real-time by the Inca PV-Loop system.

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States