NCT03431870

Brief Summary

The aim of this study is to evaluate the accuracy and reliability of intra-operative TEE after the induction of anesthesia when assessing proximal thoracic aorta diameters in a cohort of aortic aneurysm patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 21, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2022

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

4 years

First QC Date

January 23, 2018

Last Update Submit

April 6, 2021

Conditions

Aortic Aneurysm, Thoracic

Outcome Measures

Primary Outcomes (1)

  • difference in the aortic dimension

    10% difference in the aortic dimension before and after anaesthesia

    intraoperative

Study Arms (1)

Aorta dilated

OTHER

Patients with aorta of 40mm or more who undergo a cardiac surgery. The intervention include: Trans-Esophageal Echocardiography

Other: Trans-esophageal echocardiography

Interventions

Trans-esophageal echocardiographyOTHER

Perform a trans-esophageal echocardiography before and after anesthesia.

Also known as: Cardiac surgery
Aorta dilated

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ascending aorta of 40 mm and above
  • Patients who undergo cardiac surgery

You may not qualify if:

  • Unstable patients
  • Patients who underwent a previous cardiac surgery
  • Patients who were diagnosed with aortic dissection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba medical center

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Eilon Ram, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Kogan

CONTACT

972-52-8646402Diana.Kogan@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2018

First Posted

February 13, 2018

Study Start

January 21, 2018

Primary Completion

January 21, 2022

Study Completion

January 21, 2022

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)