Cardiac Strain Using Speckle Tracking Echocardiography Du... | NCT04316468

Studies
Cardiac Strain Using Speckle Tracking Echocardiography During Orthotopic Liver Transplantation

NCT04316468

Sponsor

Mayo Clinic

Status

Terminated

Last Update Posted

Apr 10, 2024Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Liver Transplant Disorder
Reperfusion Injury

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to find software to open saved images for analysis

Expanded Access Info

Start Date

Mar 10, 2020Actual

Primary Completion Date

Apr 8, 2024Actual

Completion Date

Apr 8, 2024Actual

First Submitted Date

Mar 19, 2020

First Submission Date that Met QC Criteria

Mar 19, 2020

First Posted Date

Mar 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2024

Last Update Posted Date

Apr 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Researchers are trying to improve the understanding of systolic function of the heart at the time of liver reperfusion in patients undergoing orthotopic liver transplantation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Degree of change in cardiac strain	Evaluate the degree of change to cardiac strain using speckle tracking echocardiography	Up to 1 hour after graft reperfusion

Secondary Outcomes

Measure	Description	Time Frame
Pattern of right and left ventricular strain	Describe the pattern of right and left ventricular strain throughout the course of orthotopic liver transplantion.	Up to 5 hours from the time of surgery start

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age greater than 18 years
Undergoing primary orthotopic liver transplantation

Exclusion Criteria:

Redo orthotopic transplantation
Acute or fulminant liver failure
Patient with pre-existing atrial fibrillation or hypertrophic cardiomyopathy
Patients with an abnormal preoperative stress test (EF <55%, areas of prior infarct, ongoing ischemia)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Sequential liver transplant candidates (adults) will be approached for consent to participate in the study at the time of liver transplantation by a member of the liver anesthesia team.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen Aniskevich, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Florida		Jacksonville	Florida	32224	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015427	Reperfusion Injury

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided