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Pressure-Volume Loop During High-Risk PCI

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ClinicalTrials.gov Identifier: NCT04681313
Recruitment Status : Recruiting
First Posted : December 23, 2020
Last Update Posted : February 9, 2022
Sponsor:
Collaborator:
Abiomed Inc.
Information provided by (Responsible Party):
William W. O'Neill, Henry Ford Health System

Study Description
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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.


Condition or disease Intervention/treatment
Coronary Artery Disease 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 Design
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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pressure-Volume Loop During PCI: Real-Time Left Ventricular Pressure-Volume Analysis in High-Risk PCI
Actual Study Start Date : April 19, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023
Groups and Cohorts
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Intervention Details:
  • 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.
    Other Name: HRPCI

Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681313


Contacts
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Contact: Mohammad Alquaraz, MD 313-916-2871 MALQARQ1@hfhs.org
Contact: Michael Hacala 313-916-7253 mhacala1@hfhs.org

Locations
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United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Mohammad Alqarqaz, MD       malqarq1@hfhs.org   
Sponsors and Collaborators
Henry Ford Health System
Abiomed Inc.
Investigators
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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
More Information
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Responsible Party: William W. O'Neill, Director, Center for Structural Heart Disease, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT04681313    
Other Study ID Numbers: 9809
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: February 9, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by William W. O'Neill, Henry Ford Health System:
High Risk Percutaneous Coronary Intervention
Pressure-Volume Loop
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases