NCT03534440

Brief Summary

Patients scheduled for Thoracic Endovascular Aortic Repair (TEVAR) surgery will have transthoracic echocardiography evaluation of left ventricle diastolic function during the perioperative period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

April 15, 2018

Last Update Submit

July 5, 2020

Conditions

Diastolic DysfunctionHeart FailureAneurysm Aortic

Keywords

Diastolic DysfunctionAnesthesiaPreoperative assessmentPostoperative careTEVAR

Outcome Measures

Primary Outcomes (1)

  • Change in left ventricle diastolic function in time

    Echocardiographic assessment of change in left ventricle diastolic function repeated in time intervals: Baseline before the surgery, 2 and 24 hours after the surgery

    Baseline, 2 hours and 24 hours

Secondary Outcomes (9)

  • Change in biochemistry markers: troponins

    Baseline, 2 hours and 24 hours

  • Change in biochemistry markers: brain natriuretic peptide

    Baseline, 2 hours and 24 hours

  • Change in left ventricle systolic function

    Baseline, 2 hours and 24 hours

  • Hemodynamic parameters: Heart rate

    Baseline, 2 hours and 24 hours

  • Hemodynamic parameters: Systolic and diastolic pressure

    Baseline, 2 hours and 24 hours

  • +4 more secondary outcomes

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for a Thoracic Endovascular Aortic Repair

You may qualify if:

  • scheduled TEVAR
  • \>60 years old

You may not qualify if:

  • Atrial fibrillation or other non-sinus rhythms
  • Atrioventricular blocks
  • Heart rate change more than 25% postoperatively
  • Not adequate transthoracic view
  • Postoperative shock
  • Sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Of Warsaw

Warsaw, Mazovian, 02-091, Poland

Location

MeSH Terms

Conditions

Heart FailureAortic Aneurysm

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesAneurysmVascular DiseasesAortic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2018

First Posted

May 23, 2018

Study Start

July 1, 2018

Primary Completion

December 19, 2019

Study Completion

January 30, 2020

Last Updated

July 7, 2020

Record last verified: 2020-07

Locations

PL(1)