Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

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:

  1. Weak correlation between echocardiographic measurements and hemodynamic changes during coronary artery bypass graft surgery
  2. 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

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



Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. Change in cardiac output measured with Swan-Ganz during CABG [ Time Frame: during CABG surgery ]
    Cardiac output (L/min) measured with the thermodilution technique



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).

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
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