Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
207 participants
OBSERVATIONAL
2021-08-10
2022-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients following CABG
Recruitment amongst patients enrolled in SWEDEGRAFT RCT at Aarhus University Hospital scheduled for follow-up
Echocardiography
Full 2D and 3D echocardiography with special focus on right ventricular function
Interventions
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Echocardiography
Full 2D and 3D echocardiography with special focus on right ventricular function
Eligibility Criteria
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Inclusion Criteria
* Need for at least one vein graft
* Able to provide informed consent and accepted for isolated primary CABG.
• Ability to meet for follow-up visit
• Inability to cooperate to transthoracic echocardiography
Exclusion Criteria
* 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
80 Years
ALL
No
Sponsors
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Uppsala University
OTHER
Aarhus University Hospital Skejby
OTHER
Responsible Party
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Ivy susanne Modrau, MD
Consultant Cardiac Surgeon, Associate Professor
Principal Investigators
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Ivy Modrau, MD, dr.med.
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital Skejby
Locations
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Aarhus University Hospital Skejby
Aarhus, , Denmark
Countries
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References
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Ragnarsson S, Janiec M, Modrau IS, Dreifaldt M, Ericsson A, Holmgren A, Hultkvist H, Jeppsson A, Sartipy U, Ternstrom L, Per Vikholm MD, de Souza D, James S, Thelin S. No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial. Am Heart J. 2020 Jun;224:17-24. doi: 10.1016/j.ahj.2020.03.009. Epub 2020 Mar 13.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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1-10-72-207-18-2
Identifier Type: -
Identifier Source: org_study_id
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