Pressure-Volume Loop During High-Risk PCI

Coronary Artery Disease Clinical Trial

Official title:

Pressure-Volume Loop During PCI: Real-Time Left Ventricular Pressure-Volume Analysis in High-Risk PCI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04681313
• Other study ID #: 9809
• Status: Recruiting
• Start date: April 19, 2021
• Est. completion date: December 2023

Study information

• Verified date: December 2022
• Source: Henry Ford Health System
• Contact: Mohammad Alquaraz, MD
• Phone: 313-916-2871
• Email: MALQARQ1[@]hfhs.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• High-risk percutaneous coronary intervention
Percutaneous coronary interventions (PCI) deemed high risk based on patient-related risk features, hemodynamic criteria, clinical presentation and complexity of coronary anatomy.

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	Abiomed Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in left ventricular end diastolic pressure (LVEDP).	Measured changes in left ventricular end diastolic pressure (LVEDP) as measured real-time by the Inca PV-Loop system.	Immediate (during PCI).
Primary	Changes in left ventricular end systolic pressure.	Measured changes in left ventricular end systolic pressure as measured real-time by the Inca PV-Loop system.	Immediate (during PCI).
Primary	Changes in left ventricular compliance.	Measured changes in left ventricular compliance as measured real-time by the Inca PV-Loop system.	Immediate (during PCI).