Aarhus University Hospital Skejby
Aarhus, 8200, Denmark
NCT Number: NCT05049421
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.
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Notify MeUp to 80 year
All sexes
Observational
Aarhus, 8200, Denmark
Complete study protocol attached
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
SWEDEGRAFT inclusion criteria:
Additional inclusion criteria for the Right-Heart-Substudy:
Exclusion criteria
SWEDEGRAFT exclusion criteria:
Additional inclusion criteria for the Right-Heart-Substudy:
Full 2D and 3D echocardiography with special focus on right ventricular function
Time frame: 30 months postoperative
Right ventricular function assessed by 3D echocardiography
Time frame: 30 months postoperative
Derived from two-dimensional speckle-tracking
Time frame: 30 months postoperative
Seattle Angina Questionnaire-7
-> 0 denotes the worst and 100 the best possible health status
Time frame: 30 months postoperative
NYHA class
Time frame: 30 months postoperative
Borg CR10® Scale
-> Range from 0: No exertion to 10: Maximal level of exertion
Time frame: 30 months postoperative
pg/mL
Time frame: 5 and 10 years after CABG
all-cause mortality, myocardial infarction, repeat hospitalization due to cardiac cause, cerebrovascular accident, repeat revascularization
Aarhus University Hospital Skejby
Other
Right Ventricular Function After Coronary Artery Bypass Grafting The SWEDEGRAFT Right-Heart-Substudy
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