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CompletedNCT04694378Updated Apr 25, 2024

Relationship Between Strain and Stroke Volume in Cardiac Surgery

An observational study in Right Ventricular Dysfunction, Stroke Volume Index and Longitudinal Heart Strain, sponsored by Tufts Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-25.

Sponsored by Tufts Medical Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Right Ventricular Dysfunction
  • Stroke Volume Index
  • Longitudinal Heart Strain

Keywords

  • Echocardiography
  • Coronary artery bypass graft
  • Thermodilution
03

In context

Ventricular Dysfunction, Right

90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 51 observational studies indexed under Ventricular Dysfunction, Right.

Browse Ventricular Dysfunction, Right studies →

Lead sponsor

Tufts Medical Center is the lead sponsor of 200 studies on the registry; 28 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 16 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Male and female patients older that 18 years old.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with 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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Change of right ventricular function during CABG assessed by right heart strain (%)

    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.

    Time frame: during CABG surgery

  2. Change of right ventricular function during CABG assessed by stroke volume index (mL/m2)

    Assessing the change of RV function during CABG surgery using stroke volume index. Stroke volume index measurement as millilitres per square meter (ml/m2)

    Time frame: during CABG surgery

Secondary outcomes

  1. Change in cardiac output measured with Swan-Ganz during CABG

    Cardiac output (L/min) measured with the thermodilution technique

    Time frame: during CABG surgery

07

Study locations

1 site
  • Tufts Medical Center
    Boston, Massachusetts 06111, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04694378
Responsible party
Sponsor
First posted
Jan 5, 2021
Start date
Oct 1, 2020
Primary completion
Nov 1, 2022
Completion
Nov 1, 2022
Last update
Apr 25, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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