NCT03999463

Brief Summary

The left atrial performance is affected by the preload as well as the afterload. The LA active pumping is increased by stretching of the LA but within limits, after which the active pumping declines. The LV stiffness acts as the LA afterload. Whenever the LV stiffness increases, the overall emptying fraction becomes more pumpdependent

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 2019

Shorter than P25 for all trials

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

June 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 3, 2020

Status Verified

December 1, 2019

Enrollment Period

3 months

First QC Date

June 23, 2019

Last Update Submit

December 31, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • intraoperative transoesophageal echocardiography to test the effect of Sevoflurane on left atrial performance

    Mitral inflow early diastolic velocity (meter/second)(m/s)

    30 Minutes (Start point: After induction of anesthesia and before starting sevoflurane (first set of data). End point: After achieving one MAC sevoflurane anesthesia and before skin incision (second set of data)).

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients of any sex,40-75 years, maintaining sinus rhythm undergoing elective with preserved left ventricular systolic function.

You may qualify if:

  • Clinical diagnosis of ischemic heart disease
  • Elective coronary artery bypass grafting.

You may not qualify if:

  • Atrial or ventricular dysrhythmias,
  • Associated mitral valve disease,
  • Ejection Fraction \<40%,
  • Emergency coronary artery bypass grafting,
  • Pericardial disease
  • Contraindication to perform a TEE, e.g. Esophageal tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain-Shams University Hospitals

Cairo, 11361, Egypt

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

First Submitted

June 23, 2019

First Posted

June 26, 2019

Study Start

July 1, 2019

Primary Completion

September 30, 2019

Study Completion

December 31, 2019

Last Updated

January 3, 2020

Record last verified: 2019-12

Locations