Pressure-Volume Loop During High-Risk PCI

NCT04681313 | Completed

• 1 other identifier: 9809
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

High Risk Percutaneous Coronary Intervention; Pressure-Volume Loop

Outcome Measures

Primary Outcomes (3)

• 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).

Interventions

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.

Also known as: HRPCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients (18 years and older) with known coronary artery disease and planned elective HRPCI procedures.

You may not qualify if:

• Any patient not considered appropriate for elective HRPCI procedures.

Sponsors & Collaborators

• Henry Ford Health System: lead
• Abiomed Inc.: collaborator

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• William O'Neill, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

• Mohammad Alqarqaz, MD

  Henry Ford Health System

  STUDY DIRECTOR

• Mir Babar Basir, DO

  Henry Ford Health System

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Structural Heart Disease

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: April 19, 2021
• Primary Completion: December 1, 2022
• Study Completion: September 12, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)