Coronary Artery Bypass Surgery, Right-Sided Heart Failure
Conditions
Keywords
2-D Echocardiography, 3-D Echocardiography, Coronary Artery Bypass Surgery, Right-Sided Heart Failure, Patient Reported Outcome Measures
Brief summary
BACKGROUND Right ventricular dysfunction is a common echocardiographic finding after cardiac surgery. Pericardial disruption has been suggested as the most probable cause as the phenomenon occurs within minutes after pericardial incision. The investigators suspect that validated two-dimensional echocardiographic measures for right ventricular function might not reflect the altered RV contraction pattern including paradoxical interventricular septal motion and reduced long-axis function following open cardiac surgery. The present study aims to determine the prevalence and scale of right ventricular dysfunction two years after CABG by applying the latest available two- and three-dimensional echocardiographic technology in right ventricular evaluation. In addition, the investigators investigate the impact of right ventricular dysfunction on functional outcome. METHODS The Right-Heart-Study is an observational substudy of the SWEDEGRAFT trial at Aarhus University Hospital in Denmark. SWEDEGRAFT is a nordic, multicenter, prospective, randomized, register-based, clinical trial (ClinicalTrials.gov Identifier: NCT03501303; Ragnarsson 2020). Patients for the current Right-Heart-Substudy will be recruited amongst the 269 patients included in the SWEDEGRAFT trial at Aarhus University Hospital from 10 September 2018 to 25 May 2020. Patients are enrolled at the time of SWEDEGRAFT follow-up with cardiac-CT (approximately 30 months after CABG). After written informed consent, we perform additional full 2D and 3D echocardiography with special focus on RV function, collect patient-reported data on functional outcome, and measure brain natriuretic peptide and hemoglobin levels.
Detailed description
Complete study protocol attached
Interventions
DIAGNOSTIC_TESTEchocardiography
Full 2D and 3D echocardiography with special focus on right ventricular function
Sponsors
Uppsala University
Aarhus University Hospital Skejby
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
Inclusion criteria
SWEDEGRAFT inclusion criteria: * First-time non-emergent CABG patients * Need for at least one vein graft * Able to provide informed consent and accepted for isolated primary CABG. Additional inclusion criteria for the Right-Heart-Substudy: • Ability to meet for follow-up visit
Exclusion criteria
SWEDEGRAFT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3D right ventricular ejection fraction | 30 months postoperative | Right ventricular function assessed by 3D echocardiography |
| Right ventricular strain | 30 months postoperative | Derived from two-dimensional speckle-tracking |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived exertion during exercise | 30 months postoperative | Borg CR10® Scale -\> Range from 0: No exertion to 10: Maximal level of exertion |
| Disease-specific health-related quality of life | 30 months postoperative | Seattle Angina Questionnaire-7 -\> 0 denotes the worst and 100 the best possible health status |
| Long-term Major Adverse Cardiac and Cerebrovascular Events | 5 and 10 years after CABG | all-cause mortality, myocardial infarction, repeat hospitalization due to cardiac cause, cerebrovascular accident, repeat revascularization |
| Pro-Brain Natriuretic Peptide | 30 months postoperative | pg/mL |
| Degree of dyspnea at exertion | 30 months postoperative | NYHA class |
Countries
Denmark
Outcome results
None listed