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OpenTrials
Completed

NCT Number: NCT04694378

Relationship Between Strain and Stroke Volume in Cardiac Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tufts Medical Center

Boston, Massachusetts, 06111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study title

Relationship Between Right Ventricular Free Wall Longitudinal Strain and Stroke Volume Index by Thermodilution in Patients Undergoing Cardiac Surgery

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 5, 2021
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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