Relationship Between Strain and Stroke Volume in Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT04694378

Recruitment Status : Recruiting

First Posted : January 5, 2021

Last Update Posted : January 5, 2021

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Tufts Medical Center

Study Description

Brief Summary:

Patients undergoing coronary artery bypass grafting up tp 30% will develop postoperative right ventricle dysfunction. Its imperative for the physician to fully understand the severity of this complication in order to perform an early diagnosis and carry out the appropriate treatment.

Aim:

Investigate the correlation between echocardiographic measurements and hemodynamic changes at different time points in patients undergoing coronary artery bypass graft surgery

Hypothesis:

Weak correlation between echocardiographic measurements and hemodynamic changes during coronary artery bypass graft surgery
Echocardiographic measurements would change across different time points during surgery independent of hemodynamic values.

Condition or disease
Right Ventricular Dysfunction Stroke Volume Index Longitudinal Heart Strain

Study Design

Layout table for study information

Study Type :	Observational [Patient Registry]
Estimated Enrollment :	50 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Target Follow-Up Duration:	1 Day
Official Title:	Relationship Between Right Ventricular Free Wall Longitudinal Strain and Stroke Volume Index by Thermodilution in Patients Undergoing Cardiac Surgery
Actual Study Start Date :	October 1, 2020
Estimated Primary Completion Date :	July 1, 2021
Estimated Study Completion Date :	October 31, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Change of right ventricular function during CABG assessed by right heart strain (%) [ Time Frame: during CABG surgery ]
Assessing the change of RV function during CABG surgery using right heart strain as a percentage of change between RV shortening and RV end diastolic length.
Change of right ventricular function during CABG assessed by stroke volume index (mL/m2) [ Time Frame: during CABG surgery ]
Assessing the change of RV function during CABG surgery using stroke volume index. Stroke volume index measurement as millilitres per square meter (ml/m2)

Secondary Outcome Measures :

Change in cardiac output measured with Swan-Ganz during CABG [ Time Frame: during CABG surgery ]
Cardiac output (L/min) measured with the thermodilution technique

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Male and female patients older that 18 years old.

Criteria

Inclusion Criteria:

- Elective coronary artery bypass graft patients who require pulmonary catheter placement for intraoperative monitoring.

Exclusion Criteria:

Patients with contraindication to Swan-Ganz catheter placement,
Pre-existing atrial arrhythmias,
Patients with moderate and/or severe mitral/tricuspid valve stenosis or regurgitation
Patients with contraindication to transesophageal echocardiogram probe placement (i.e. esophageal stenosis).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04694378

Locations

Layout table for location information

United States, Massachusetts
Tufts Medical Center	Recruiting
Boston, Massachusetts, United States, 06111
Contact: Luis Gonzalez Ciccarelli 617-636-6208 lgonzalezciccar@tuftsmedicalcenter.org

Sponsors and Collaborators

Tufts Medical Center

More Information

Layout table for additonal information

Responsible Party:	Tufts Medical Center
ClinicalTrials.gov Identifier:	NCT04694378
Other Study ID Numbers:	1
First Posted:	January 5, 2021 Key Record Dates
Last Update Posted:	January 5, 2021
Last Verified:	January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Tufts Medical Center:


Echocardiography Coronary artery bypass graft Thermodilution

Additional relevant MeSH terms:

Layout table for MeSH terms

Stroke Ventricular Dysfunction Ventricular Dysfunction, Right Sprains and Strains Cerebrovascular Disorders Brain Diseases	Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Wounds and Injuries Heart Diseases

To Top