Coronary Artery DiseaseRaFeNCT06112561
Cardiac Index, SVR/SVRI During Weaning From ECC- Data Obtained From Femoral and Radial Artery Transducer
A study testing CO/CI/SVR in people with Coronary Artery Disease and Aortic Valve Disease, run by George Papanicolaou Hospital.
Trial summary
Swan Ganz catheter-Edwards Lifesciences obtains values of cardiac output/index and systemic vascular resistance/index using the mean artery pressure of either radial or femoral artery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease
- What is being tested?
- CO/CI/SVR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to May 2024
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Coronary artery disease , aortic valve stenosis, aortic valve regurgitation, mitral valve stenosis, mitral valve regurgitation,
Exclusion Criteria: none
Trial locations and contacts
No sites are listed yet.
Theodoros Karaiskos, MD,PhD contact
About this study
Official title: Fluctuation and Realbility of Cardiac Index and SVR/SVRI During Weaning From ECC Regarding Values Obtained From Femoral and Radial Artery Acumen IQ Sensor
Swan Ganz catheter-Edwards Lifesciences obtains values of cardiac output/index and systemic vascular resistance/index using the mean artery pressure of either radial or femoral artery.
During weaning from extracorporeal circulation, arterial waveform-derived cardiac output measurements from radial cannulation site is not reliable as compared with measurements obtained from femoral cannulation site.
Read the detailed description
50 consecutive cardiac surgical patients undergoing on-pump primary coronary artery bypass, valve replacement or combined surgery are included in the study. Cardiac output is measured sequentially by the arterial pressure waveform analysis method from radial and femoral arterial sites
- Being tested
- CO/CI/SVR
- Keywords
- cardiac output, cardiac index, systemic vascular resistance
- Medical subject headings
- Coronary Artery Disease, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO/CI/SVRDevice
fluctuations of CO/CI/SVR regarding data from radial or femoral arterial cannula, and the therapeutic intervention that it demands these values.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac output/index/SVR | Active comparator | Record of CO/CI/SVR before and after weaning form ECC from radial and femoral artery cannula. Receives: Device: CO/CI/SVR |
| Hypotension event | Active comparator | Prevent of hypotension event calculated from radial/femoral artery cannula Receives: Device: CO/CI/SVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
Measurement of cardiac output from radial and femoral arterial cannula
Measured: 5 minutes after weaning from extracorporeal circulation (ECC)
Prediction of hypotension episode (HPI)
Measurement of possibility of hypotension episode (HPI) from femoral and radial arterial cannula
Measured: 5 minutes after weaning from ECC
Systemic Vascular resistance (SVR)
Measurement of SVR from femoral and radial arterial cannula
Measured: 5 minutes after weaning from ECC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study startJan 2024 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Papanicolaou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asouhidou Irene, George Papanicolaou Hospital
- Investigators
- Olga Ananiadou, MD,PhD, Study chair, George PAPANIKOLAOU G.H.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112561
- Sponsor's protocol ID
- Aqumen23
- Acronym
- RaFe
- Status last verified
- Jan 2024
- First submitted
- 22 Oct 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluctuation and Realbility of Cardiac Index and SVR/SVRI During Weaning From ECC Regarding Values Obtained From Femoral and Radial Artery Acumen IQ Sensor
- ClinicalTrials.gov ID
- NCT06112561
- Acronym / sponsor ID
- RaFe / Aqumen23
- Keywords
- cardiac output, cardiac index, systemic vascular resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- George Papanicolaou HospitalUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 1 Nov 2023 (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.
Swan Ganz catheter-Edwards Lifesciences obtains values of cardiac output/index and systemic vascular resistance/index using the mean artery pressure of either radial or femoral artery.
During weaning from extracorporeal circulation, arterial waveform-derived cardiac output measurements from radial cannulation site is not reliable as compared with measurements obtained from femoral cannulation site.
Detailed description
50 consecutive cardiac surgical patients undergoing on-pump primary coronary artery bypass, valve replacement or combined surgery are included in the study. Cardiac output is measured sequentially by the arterial pressure waveform analysis method from radial and femoral arterial sites
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac output/index/SVR | Active comparator | Device: CO/CI/SVRRecord of CO/CI/SVR before and after weaning form ECC from radial and femoral artery cannula. |
| Hypotension event | Active comparator | Device: CO/CI/SVRPrevent of hypotension event calculated from radial/femoral artery cannula |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CO/CI/SVRfluctuations of CO/CI/SVR regarding data from radial or femoral arterial cannula, and the therapeutic intervention that it demands these values. | Device | Cardiac output/index/SVR, Hypotension event |
Primary outcome
Cardiac output
Time frame: 5 minutes after weaning from extracorporeal circulation (ECC)
Measurement of cardiac output from radial and femoral arterial cannula
Prediction of hypotension episode (HPI)
Time frame: 5 minutes after weaning from ECC
Measurement of possibility of hypotension episode (HPI) from femoral and radial arterial cannula
Systemic Vascular resistance (SVR)
Time frame: 5 minutes after weaning from ECC
Measurement of SVR from femoral and radial arterial cannula
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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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.
Theodoros Karaiskos, MD,PhD contact
Olga Ananiadou, MD,PhD study chair
George PAPANIKOLAOU G.H.
Questions about this trial
What is this clinical trial studying?
A study testing CO/CI/SVR in people with Coronary Artery Disease and Aortic Valve Disease, run by George Papanicolaou Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene Asouhidou, MD,PhD (00306944740633, iasouh@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (time frame: 5 minutes after weaning from extracorporeal circulation (ECC)). 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 17 Jan 2024.