Pressure-Volume Loop During High-Risk PCI

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: High-risk percutaneous coronary intervention

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 Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Mohammad Alquaraz, MD; Phone Number: 313-916-2871; Email: MALQARQ1@hfhs.org
• Study Contact Backup: Name: Michael Hacala; Phone Number: 313-916-7253; Email: mhacala1@hfhs.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital
      • Contact: Mohammad Alqarqaz, MD; Email: malqarq1@hfhs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ten adult patients with planned elective HRPCI procedures. Procedures are deemed high-risk based on patient-related risk features, hemodynamic criteria, clinical presentation and complexity of coronary anatomy. Patient-related high risk features include low left ventricle ejection fraction (LVEF), advanced age, and comorbidities including advanced kidney disease, peripheral and cerebral vascular disease. High-risk baseline hemodynamic features include hypotension, severely elevated LVEDP, and severely depressed cardiac output. Coronary anatomy complexity criteria include left main coronary artery involvement, multi- vessel CAD, and severely calcified coronary lesions requiring atherectomy.

The decision to use an MCS device for hemodynamic support will be planned, not randomized, as it will be made prior to patient enrollment based on the clinical judgment of the treating physician.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
Changes in left ventricular compliance.	Measured changes in left ventricular compliance as measured real-time by the Inca PV-Loop system.	Immediate (during PCI).

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: Abiomed Inc.
• Investigators: Principal Investigator: William O'Neill, MD, Henry Ford Health System; Study Director: Mohammad Alqarqaz, MD, Henry Ford Health System; Study Director: Mir Babar Basir, DO, Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: High Risk Percutaneous Coronary Intervention; Pressure-Volume Loop
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 9809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No