Clinical trial NCT04681313: Pressure-Volume Loop During High-Risk PCI
Official title: Pressure-Volume Loop During PCI: Real-Time Left Ventricular Pressure-Volume Analysis in High-Risk PCI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: High Risk Percutaneous Coronary Intervention
Pressure-Volume Loop
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Abiomed Inc.
First posted: 2020-12-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in left ventricular end diastolic pressure (LVEDP).
timeFrame: Immediate (during PCI).
measure: Changes in left ventricular end systolic pressure.
timeFrame: Immediate (during PCI).
measure: Changes in left ventricular compliance.
timeFrame: Immediate (during PCI).
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: William O'Neill, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Health System
name: Mohammad Alqarqaz, MD
role: STUDY_DIRECTOR
affiliation: Henry Ford Health System
name: Mir Babar Basir, DO
role: STUDY_DIRECTOR
References: