The SWEDEGRAFT Right-Heart-Substudy

NCT05049421 | Completed

• 1 other identifier: 1-10-72-207-18-2
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass Surgery; Right-Sided Heart Failure

Keywords

2-D Echocardiography; 3-D Echocardiography; Coronary Artery Bypass Surgery; Right-Sided Heart Failure; Patient Reported Outcome Measures

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Disease-specific health-related quality of life

  30 months postoperative

• Degree of dyspnea at exertion

  30 months postoperative

• Perceived exertion during exercise

  30 months postoperative

• Pro-Brain Natriuretic Peptide

  30 months postoperative

• Long-term Major Adverse Cardiac and Cerebrovascular Events

  5 and 10 years after CABG

Study Arms (1)

Patients following CABG

Recruitment amongst patients enrolled in SWEDEGRAFT RCT at Aarhus University Hospital scheduled for follow-up

Diagnostic Test: Echocardiography

Interventions

Echocardiography DIAGNOSTIC_TEST

Full 2D and 3D echocardiography with special focus on right ventricular function

Patients following CABG

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients enrolled in the SWEDEGRAFT RCT due to 2,5 year follow-up. Patients have undergone elective stand-alone first-time coronary artery bypass grafting

You may qualify if:

• First-time non-emergent CABG patients
• 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

You may not qualify if:

• No greater saphenous vein grafts available (previous vein stripping or poor vein quality)
• Allergy to contrast dye
• 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
• Inability to cooperate to transthoracic echocardiography

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead
• Uppsala University: collaborator

Study Sites (1)

Aarhus University Hospital Skejby

Aarhus, 8200, Denmark

Location

Related Publications (1)

• 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.

  PMID: 32272256 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Ivy Modrau, MD, dr.med.

  Aarhus University Hospital Skejby

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiac Surgeon, Associate Professor

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 20, 2021
• Study Start: August 10, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)