Evaluation of Speckle Tracking Parameters as Predictors of Successful VA SPECKLE ECMO

NCT03532529 | Unknown

• 1 other identifier: 241001
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cardiogenic Shock

Outcome Measures

Primary Outcomes (1)

• 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 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

  within 30 days from VA ECMO liberation

Study Arms (2)

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

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

Other: not applicable, it is an observational study

Interventions

not applicable, it is an observational study OTHER

not applicable, it is an observational study

experiencing the composit outcome; not experiencing the composit outcome

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton Hospital and Harefield NHS Foundation Trust

London, SW3 6NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: May 22, 2018
• Study Start: November 28, 2018
• Primary Completion: November 28, 2019
• Study Completion: November 28, 2019
• Last Updated: December 7, 2018

Record last verified: 2018-12

Locations

GB (1)