Cardiogenic ShockSPECKLE-ECMONCT03532529
Evaluation of Speckle Tracking Parameters as Predictors of Successful VA SPECKLE ECMO
An observational study of Cardiogenic Shock, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Purpose of this study is to assess whether measurements obtained through speckle tracking (LV longitudinal and circumferential strain, RV longitudinal strain) can give additional information in identifying patients who develop adverse outcomes 30 days post successfully weaning from VA ECMO (liberation not for… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- not applicable, it is an observational study
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Nov 2018to 28 Nov 2019
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: All patients admitted to the ICU requiring mechanical circulatory support with VA ECMO and a diagnosis of cardiogenic shock (of any aetiology) who recover cardiac function to the point of decision to liberate (to wean) from VA ECMO.
Who may be able to join
- 18 to 60 years.
- Receiving VA ECMO mechanical circulatory support for cardiogenic shock and planning to undergo an echocardiogram as part of a VA ECMO weaning study.
- Informed consent for study participation provided by the patient (where able) or personal consultee (where the patient is unable to provide consent) or nominated consultee (where the patient is unable to provide consent and no personal consultee is available).
Who cannot join
- Contraindication to transoesophageal echocardiography.
- Patients who are expected to require heart transplantation, LVAD or biventricular VAD within 30 days from admission.
- Patients who are not expected to survive weaning from VA ECMO (liberation from VA ECMO exclusively for purpose of palliation).
- Contemporary presence of Impella device during VA ECMO weaning study.
- Patients in atrial fibrillation or in a different rhythm from sinus at the moment of VA ECMO weaning study.
- Patient's LVOT VTI is less than 10cm at any stage of VA ECMO weaning study and/or LVOT VTI is lower at the lowest achieved blood flow than it was at baseline (LVOT VTI criterion).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton Hospital and Harefield NHS Foundation Trust
London, SW3 6NP
Susanna Price, Chief Investigator, +442073528121, s.price@rbht.nhs.uk
About this study
Official title: Evaluation of Speckle Tracking Parameters as Predictors of Successful VA ECMO Weaning Procedure. A Prospective Observational Pilot Study.
Purpose of this study is to assess whether measurements obtained through speckle tracking (LV longitudinal and circumferential strain, RV longitudinal strain) can give additional information in identifying patients who develop adverse outcomes 30 days post successfully weaning from VA ECMO (liberation not for palliation). It is a prospective observational non-blinded pilot study.
In order to achieve this purpose, speckle tracking analysis will be performed on the recorded images of the transoesophageal echocardiogram performed during the last VA ECMO weaning study of patients defined ready for VA ECMO liberation. VA ECMO liberation will be based according to LVOT VTI increase and clinical judgment during patients' VA ECMO weaning study. It will be assessed whether the population experiencing the outcomes of interest (death within 30 days from VA ECMO liberation, hospital admission for a new episode of cardiogenic shock or heart failure within 30 days from VA ECMO liberation, need for new mechanical circulatory support within 30 days from VA ECMO liberation) and the population not experiencing these outcomes have different values of strain (LV longitudinal and circumferential and RV longitudinal strain) during the weaning study.
Read the detailed description
This project is non-commercial study which aims to assess whether measurements derived through speckle tracking give additional information to conventional echocardiographic parameters (LVOT VTI measurements, etc.) in identifying patients at greatest risk of major clinical events occurring within 30 days after VA ECMO liberation. It is a prospective observational non-blinded pilot study. In this study will be investigated whether particular values of strain (longitudinal and circumferential LV longitudinal and circumferential and RV longitudinal strain) and conventional echocardiographic parameters, obtained during VA ECMO weaning studies, are more associated to major clinical outcomes within 30 days after VA ECMO liberation.
The population consists of patients receiving VA ECMO mechanical circulatory support for cardiogenic shock, who have undergone an echocardiogram as part of the weaning process and a decision has been made to attempt weaning from VA ECMO. The decision to wean the patient from VA ECMO will be made by the attending clinician who will be aware of all echocardiographic measurements with the exception of the speckle tracking results (as is the standard-of-care at our institution). The study investigator who will perform all speckle tracking analysis will not be involved in the decision to wean from VA ECMO.
SCHEMATIC OF STUDY DESIGN
- Screening of VA ECMO patients in whom a weaning study is planned
- Definitive SCREENING FAILURE = patients who do not fulfil inclusion criteria or have at least one exclusion criterion (not including the LVOT VTI criterion)
- VA ECMO weaning study performed
- Patients deemed unsuitable for liberation from VA ECMO at this time are not enrolled for analysis, and are reassessed following the next weaning study
- Patients deemed suitable for liberation from VA ECMO, but whose LVOT VTI was <10cm at any stage of the weaning study, or whose LVOT VTI at lowest achieved flow was lower than baseline are excluded
- Patients deemed suitable for liberation from VA ECMO and not excluded based on LVOT VTI criterion are enrolled.
- EVALUATION OF SPECKLE TRACKING FINDINGS (LV LONGITUDINAL AND CIRCUMFERENTIAL AND RV LONGITUDINAL STRAIN) AND CONVENTIONAL ECHOCARDIOGRAPHIC PARAMETERS WITH CLINICAL OUTCOMES AT 30 DAYS POST VA ECMO LIBERATION (REMOVAL)
- Conditions
- Cardiogenic Shock
- Being tested
- not applicable, it is an observational study
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not applicable, it is an observational studyOther
not applicable, it is an observational study
| Study group | Role | What they receive |
|---|---|---|
| experiencing the composit outcome | Average values of LV longitudinal strain^ (Midesophageal 4 chamber view) in patients who developed the composite outcome including the following outcomes of interest:
* death within 30 days from VA ECMO liberation
* the necessity of new Mechanical Circulatory Support (VA-ECMO, Impella, LVAD) within 30 days from VA ECMO liberation
o Whether after VA ECMO liberation the patient still needs IABP or a RVAD support, this situation is not considered necessity of new Mechanical Circulatory Support. A necessity of new Mechanical Circulatory Support is defined when IABP or RVAD or VA ECMO or Impella are needed again after their removal
* heart transplantation within 30 days from VA ECMO liberation Receives: Other: not applicable, it is an observational study | |
| not experiencing the composit outcome | Average values of LV longitudinal strain^ (Midesophageal 4 chamber view) in patients who did not develop the composite outcome including the following outcomes of interest:
* death within 30 days from VA ECMO liberation
* the necessity of new Mechanical Circulatory Support (VA-ECMO, Impella, LVAD) within 30 days from VA ECMO liberation
o Whether after VA ECMO liberation the patient still needs IABP or a RVAD support, this situation is not considered necessity of new Mechanical Circulatory Support. A necessity of new Mechanical Circulatory Support is defined when IABP or RVAD or VA ECMO or Impella are needed again after their removal
* heart transplantation within 30 days from VA ECMO liberation Receives: Other: not applicable, it is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
the composite outcome
the composite outcome including the following outcomes of interest:
- death within 30 days from VA ECMO liberation
- the necessity of new Mechanical Circulatory Support (VA-ECMO, Impella, LVAD) within 30 days from VA ECMO liberation
- Whether after VA ECMO liberation the patient still needs IABP or a RVAD support, this situation is not considered necessity of new Mechanical Circulatory Support. A necessity of new Mechanical Circulatory Support is defined when IABP or RVAD or VA ECMO or Impella are needed again after their removal
- heart transplantation within 30 days from VA ECMO liberation
Measured: within 30 days from VA ECMO liberation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start28 Nov 2018
- Primary completion28 Nov 2019 (estimated)
- Study completion28 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532529
- Sponsor's protocol ID
- 241001
- Acronym
- SPECKLE-ECMO
- Status last verified
- Dec 2018
- First submitted
- 10 May 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Speckle Tracking Parameters as Predictors of Successful VA ECMO Weaning Procedure. A Prospective Observational Pilot Study.
- ClinicalTrials.gov ID
- NCT03532529
- Acronym / sponsor ID
- SPECKLE-ECMO / 241001
- Conditions
- Cardiogenic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 28 Nov 2019 (estimated)
- Study completion
- 28 Nov 2019 (estimated)
- First posted
- 22 May 2018 (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.
Purpose of this study is to assess whether measurements obtained through speckle tracking (LV longitudinal and circumferential strain, RV longitudinal strain) can give additional information in identifying patients who develop adverse outcomes 30 days post successfully weaning from VA ECMO (liberation not for palliation). It is a prospective observational non-blinded pilot study.
In order to achieve this purpose, speckle tracking analysis will be performed on the recorded images of the transoesophageal echocardiogram performed during the last VA ECMO weaning study of patients defined ready for VA ECMO liberation. VA ECMO liberation will be based according to LVOT VTI increase and clinical judgment during patients' VA ECMO weaning study. It will be assessed whether the population experiencing the outcomes of interest (death within 30 days from VA ECMO liberation, hospital admission for a new episode of cardiogenic shock or heart failure within 30 days from VA ECMO liberation, need for new mechanical circulatory support within 30 days from VA ECMO liberation) and the population not experiencing these outcomes have different values of strain (LV longitudinal and circumferential and RV longitudinal strain) during the weaning study.
Detailed description
This project is non-commercial study which aims to assess whether measurements derived through speckle tracking give additional information to conventional echocardiographic parameters (LVOT VTI measurements, etc.) in identifying patients at greatest risk of major clinical events occurring within 30 days after VA ECMO liberation. It is a prospective observational non-blinded pilot study. In this study will be investigated whether particular values of strain (longitudinal and circumferential LV longitudinal and circumferential and RV longitudinal strain) and conventional echocardiographic parameters, obtained during VA ECMO weaning studies, are more associated to major clinical outcomes within 30 days after VA ECMO liberation.
The population consists of patients receiving VA ECMO mechanical circulatory support for cardiogenic shock, who have undergone an echocardiogram as part of the weaning process and a decision has been made to attempt weaning from VA ECMO. The decision to wean the patient from VA ECMO will be made by the attending clinician who will be aware of all echocardiographic measurements with the exception of the speckle tracking results (as is the standard-of-care at our institution). The study investigator who will perform all speckle tracking analysis will not be involved in the decision to wean from VA ECMO.
SCHEMATIC OF STUDY DESIGN
- Screening of VA ECMO patients in whom a weaning study is planned
- Definitive SCREENING FAILURE = patients who do not fulfil inclusion criteria or have at least one exclusion criterion (not including the LVOT VTI criterion)
- VA ECMO weaning study performed
- Patients deemed unsuitable for liberation from VA ECMO at this time are not enrolled for analysis, and are reassessed following the next weaning study
- Patients deemed suitable for liberation from VA ECMO, but whose LVOT VTI was <10cm at any stage of the weaning study, or whose LVOT VTI at lowest achieved flow was lower than baseline are excluded
- Patients deemed suitable for liberation from VA ECMO and not excluded based on LVOT VTI criterion are enrolled.
- EVALUATION OF SPECKLE TRACKING FINDINGS (LV LONGITUDINAL AND CIRCUMFERENTIAL AND RV LONGITUDINAL STRAIN) AND CONVENTIONAL ECHOCARDIOGRAPHIC PARAMETERS WITH CLINICAL OUTCOMES AT 30 DAYS POST VA ECMO LIBERATION (REMOVAL)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiencing the composit outcome | – | Other: not applicable, it is an observational studyAverage values of LV longitudinal strain^ (Midesophageal 4 chamber view) in patients who developed the composite outcome including the following outcomes of interest: * death within 30 days from VA ECMO liberation * the necessity of new Mechanical Circulatory Support (VA-ECMO, Impella, LVAD) within 30 days from VA ECMO liberation o Whether after VA ECMO liberation the patient still needs IABP or a RVAD support, this situation is not considered necessity of new Mechanical Circulatory Support. A necessity of new Mechanical Circulatory Support is defined when IABP or RVAD or VA ECMO or Impella are needed again after their removal * heart transplantation within 30 days from VA ECMO liberation |
| not experiencing the composit outcome | – | Other: not applicable, it is an observational studyAverage values of LV longitudinal strain^ (Midesophageal 4 chamber view) in patients who did not develop the composite outcome including the following outcomes of interest: * death within 30 days from VA ECMO liberation * the necessity of new Mechanical Circulatory Support (VA-ECMO, Impella, LVAD) within 30 days from VA ECMO liberation o Whether after VA ECMO liberation the patient still needs IABP or a RVAD support, this situation is not considered necessity of new Mechanical Circulatory Support. A necessity of new Mechanical Circulatory Support is defined when IABP or RVAD or VA ECMO or Impella are needed again after their removal * heart transplantation within 30 days from VA ECMO liberation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients admitted to the ICU requiring mechanical circulatory support with VA ECMO and a diagnosis of cardiogenic shock (of any aetiology) who recover cardiac function to the point of decision to liberate (to wean) from VA ECMO.
Key inclusion criteria (3 listed)
- 18 to 60 years.
- Receiving VA ECMO mechanical circulatory support for cardiogenic shock and planning to undergo an echocardiogram as part of a VA ECMO weaning study.
- Informed consent for study participation provided by the patient (where able) or personal consultee (where the patient is unable to provide consent) or nominated consultee (where the patient is unable to provide consent and no personal consultee is available).
Key exclusion criteria (6 listed)
- Contraindication to transoesophageal echocardiography.
- Patients who are expected to require heart transplantation, LVAD or biventricular VAD within 30 days from admission.
- Patients who are not expected to survive weaning from VA ECMO (liberation from VA ECMO exclusively for purpose of palliation).
- Contemporary presence of Impella device during VA ECMO weaning study.
- Patients in atrial fibrillation or in a different rhythm from sinus at the moment of VA ECMO weaning study.
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 |
|---|---|---|
| not applicable, it is an observational studynot applicable, it is an observational study | Other | experiencing the composit outcome, not experiencing the composit outcome |
Primary outcome
the composite outcome
Time frame: within 30 days from VA ECMO liberation
the composite outcome including the following outcomes of interest: * death within 30 days from VA ECMO liberation * the necessity of new Mechanical Circulatory Support (VA-ECMO, Impella, LVAD) within 30 days from VA ECMO liberation o Whether after VA ECMO liberation the patient still needs IABP or a RVAD support, this situation is not considered necessity of new Mechanical Circulatory Support. A necessity of new Mechanical Circulatory Support is defined when IABP or RVAD or VA ECMO or Impella are needed again after their removal * heart transplantation within 30 days from VA ECMO liberation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Royal Brompton Hospital and Harefield NHS Foundation Trust
London, United Kingdom
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 Cardiogenic Shock, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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 6 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 7 Dec 2018. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the composite outcome (time frame: within 30 days from VA ECMO liberation). 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 7 Dec 2018.