Right Ventricular Function After Coronary Artery Bypass Grafting The SWEDEGRAFT Right-Heart-Substudy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 207
- Locations
- 1
- Primary Endpoint
- 3D right ventricular ejection fraction
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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 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
Outcomes
Primary Outcomes
3D right ventricular ejection fraction
Time Frame: 30 months postoperative
Right ventricular function assessed by 3D echocardiography
Right ventricular strain
Time Frame: 30 months postoperative
Derived from two-dimensional speckle-tracking
Secondary Outcomes
- Perceived exertion during exercise(30 months postoperative)
- Degree of dyspnea at exertion(30 months postoperative)
- Long-term Major Adverse Cardiac and Cerebrovascular Events(5 and 10 years after CABG)
- Disease-specific health-related quality of life(30 months postoperative)
- Pro-Brain Natriuretic Peptide(30 months postoperative)
Investigators
Ivy susanne Modrau, MD
Consultant Cardiac Surgeon, Associate Professor
Aarhus University Hospital Skejby