The SWEDEGRAFT Right-Heart-Substudy

Study Overview
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Brief Summary
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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
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Complete study protocol attached

Official Title
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Right Ventricular Function After Coronary Artery Bypass Grafting The SWEDEGRAFT Right-Heart-Substudy

Conditions
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Coronary Artery Bypass Surgery, Right-Sided Heart Failure

Intervention / Treatment
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* Diagnostic Test: Echocardiography


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria: No greater saphenous vein grafts available (previous vein stripping or poor vein quality) Age > 80 years at the time of inclusion Allergy to contrast dye Renal failure with eGFR <15 ml/min at primary inclusion Coagulation disorders Excessive risk of wound infection Participation in other interventional trial on grafts Any condition that seriously increases the risk of non-compliance or loss of follow-up Pregnant women or women of child bearing potential without negative pregnancy test Additional inclusion criteria for the Right-Heart-Substudy: • Inability to cooperate to transthoracic echocardiography

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients following CABG<br>Recruitment amongst patients enrolled in SWEDEGRAFT RCT at Aarhus University Hospital scheduled for follow-up | Diagnostic Test: Echocardiography<br>* Full 2D and 3D echocardiography with special focus on right ventricular function<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D right ventricular ejection fraction | Right ventricular function assessed by 3D echocardiography | 30 months postoperative | 
| Right ventricular strain | Derived from two-dimensional speckle-tracking | 30 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-specific health-related quality of life | Seattle Angina Questionnaire-7 -> 0 denotes the worst and 100 the best possible health status | 30 months postoperative | 
| Degree of dyspnea at exertion | NYHA class | 30 months postoperative | 
| Perceived exertion during exercise | Borg CR10® Scale -> Range from 0: No exertion to 10: Maximal level of exertion | 30 months postoperative | 
| Pro-Brain Natriuretic Peptide | pg/mL | 30 months postoperative | 
| Long-term Major Adverse Cardiac and Cerebrovascular Events | all-cause mortality, myocardial infarction, repeat hospitalization due to cardiac cause, cerebrovascular accident, repeat revascularization | 5 and 10 years after CABG | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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2-D Echocardiography, 3-D Echocardiography, Coronary Artery Bypass Surgery, Right-Sided Heart Failure, Patient Reported Outcome Measures