Adult Cardiac SurgeryNCT02407574
Assessment of the Force Frequency Relationship of the Myocardium After On-pump CABG Surgery
A study testing External Pacing Box in people with Adult Cardiac Surgery, run by University of Liege.
Trial summary
The aim of the study is to determine whether increasing the heart rate by epicardial atrial pacing after surgery improves the contractile force of the myocardium. After complete weaning from CPB, several pressure-loops of the LV will be recorded at different levels of preload using transoesophageal echo, invasive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Cardiac Surgery
- What is being tested?
- External Pacing Box
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CABG only surgery
- Preopeartive LVEF ≥ 53 %
- Use of epicardial pacing wires to assist CPB weaning
Who cannot join
- Contra-indication to TEE
- AV block at the time of CPB weaning
- Sinus rhythm less than 50 or more than 90 BPM after CPB weaning.
About this study
The aim of the study is to determine whether increasing the heart rate by epicardial atrial pacing after surgery improves the contractile force of the myocardium. After complete weaning from CPB, several pressure-loops of the LV will be recorded at different levels of preload using transoesophageal echo, invasive blood pressure monitoring. The preload will be manipulated by adding fluid from the CPB reservoir or draining fluid into the CPB reservoir.
- Conditions
- Adult Cardiac Surgery
- Being tested
- External Pacing Box
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Pacing BoxDevice
Atrial pacing using an external pacing box
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous rhythm first | Experimental | Stepwise preload increase by repeated administration of 100 mL of fluid during spontaneous rhythm and then stepwise preload reduction by repeated drainage of 100 mL of fluid during atrial pacing. Receives: Device: External Pacing Box |
| Atrial pacing first | Experimental | Stepwise preload increase by repeated administration of 100 mL of fluid during atrial pacing and then stepwise preload reduction by repeated drainage of 100 mL of fluid during spontaneous rhythm. Receives: Device: External Pacing Box |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-systolic elastane of the left ventricle.
Measured: 30 minutes after CPB weaning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Cardiac SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407574
- Sponsor's protocol ID
- FFR2015
- Status last verified
- Mar 2015
- First submitted
- 24 Mar 2015
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Force Frequency Relationship of the Myocardium After On-pump CABG Surgery
- ClinicalTrials.gov ID
- NCT02407574
- Acronym / sponsor ID
- FFR2015
- Conditions
- Adult Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2015 (estimated)
- First posted
- 3 Apr 2015 (estimated)
- 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.
The aim of the study is to determine whether increasing the heart rate by epicardial atrial pacing after surgery improves the contractile force of the myocardium. After complete weaning from CPB, several pressure-loops of the LV will be recorded at different levels of preload using transoesophageal echo, invasive blood pressure monitoring. The preload will be manipulated by adding fluid from the CPB reservoir or draining fluid into the CPB reservoir.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spontaneous rhythm first | Experimental | Device: External Pacing BoxStepwise preload increase by repeated administration of 100 mL of fluid during spontaneous rhythm and then stepwise preload reduction by repeated drainage of 100 mL of fluid during atrial pacing. |
| Atrial pacing first | Experimental | Device: External Pacing BoxStepwise preload increase by repeated administration of 100 mL of fluid during atrial pacing and then stepwise preload reduction by repeated drainage of 100 mL of fluid during spontaneous rhythm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CABG only surgery
- Preopeartive LVEF ≥ 53 %
- Use of epicardial pacing wires to assist CPB weaning
Key exclusion criteria (3 listed)
- Contra-indication to TEE
- AV block at the time of CPB weaning
- Sinus rhythm less than 50 or more than 90 BPM after CPB weaning.
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 |
|---|---|---|
| External Pacing BoxAtrial pacing using an external pacing box | Device | Atrial pacing first, Spontaneous rhythm first |
Primary outcome
End-systolic elastane of the left ventricle.
Time frame: 30 minutes after CPB weaning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing External Pacing Box in people with Adult Cardiac Surgery, run by University of Liege.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Apr 2015. 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?
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?
End-systolic elastane of the left ventricle. (time frame: 30 minutes after CPB weaning). 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 3 Apr 2015.