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Completed

NCT Number: NCT04681313

Pressure-Volume Loop During 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-risk percutaneous coronary intervention

Procedure

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

Other names: HRPCI

Primary outcomes

  1. Changes in left ventricular end diastolic pressure (LVEDP).

    Time frame: Immediate (during PCI).

    Measured changes in left ventricular end diastolic pressure (LVEDP) as measured real-time by the Inca PV-Loop system.

  2. Changes in left ventricular end systolic pressure.

    Time frame: Immediate (during PCI).

    Measured changes in left ventricular end systolic pressure as measured real-time by the Inca PV-Loop system.

  3. Changes in left ventricular compliance.

    Time frame: Immediate (during PCI).

    Measured changes in left ventricular compliance as measured real-time by the Inca PV-Loop system.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Abiomed Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Dec 23, 2020
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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