Coronary Artery DiseaseNCT04681313
Pressure-Volume Loop During High-Risk PCI
An observational study of Coronary Artery Disease, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- High-risk percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2021to 12 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients (18 years and older) with known coronary artery disease and planned elective HRPCI procedures.
Who cannot join
- Any patient not considered appropriate for elective HRPCI procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Coronary Artery Disease
- Being tested
- High-risk percutaneous coronary intervention
- Keywords
- High Risk Percutaneous Coronary Intervention, Pressure-Volume Loop
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-risk percutaneous coronary interventionProcedure or surgery
Also called HRPCI
Percutaneous coronary interventions (PCI) deemed high risk based on patient-related risk features, hemodynamic criteria, clinical presentation and complexity of coronary anatomy.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediate (during PCI).
Changes in left ventricular compliance.
Measured changes in left ventricular compliance as measured real-time by the Inca PV-Loop system.
Measured: Immediate (during PCI).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start19 Apr 2021
- Primary completion1 Dec 2022
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Abiomed Inc.
- Responsible party
- Principal investigator, William W. O'Neill, Henry Ford Health System
- Investigators
- William O'Neill, MD, Principal investigator, Henry Ford Health SystemMohammad Alqarqaz, MD, Study director, Henry Ford Health SystemMir Babar Basir, DO, Study director, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681313
- Sponsor's protocol ID
- 9809
- Status last verified
- Nov 2024
- First submitted
- 18 Dec 2020
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure-Volume Loop During PCI: Real-Time Left Ventricular Pressure-Volume Analysis in High-Risk PCI
- ClinicalTrials.gov ID
- NCT04681313
- Acronym / sponsor ID
- 9809
- Conditions
- Coronary Artery Disease
- Keywords
- High Risk Percutaneous Coronary Intervention, Pressure-Volume Loop
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Abiomed Inc.
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients (18 years and older) with known coronary artery disease and planned elective HRPCI procedures.
Key exclusion criteria (1 listed)
- Any patient not considered appropriate for elective HRPCI procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-risk percutaneous coronary interventionAlso: HRPCIPercutaneous coronary interventions (PCI) deemed high risk based on patient-related risk features, hemodynamic criteria, clinical presentation and complexity of coronary anatomy. | Procedure or surgery | – |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William O'Neill, MD principal investigator
Henry Ford Health System
Mohammad Alqarqaz, MD study director
Henry Ford Health System
Mir Babar Basir, DO study director
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in left ventricular end diastolic pressure (LVEDP). (time frame: Immediate (during PCI).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.