The SWEDEGRAFT Right-Heart-Substudy

Overview

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.

Full Title of Study: “Right Ventricular Function After Coronary Artery Bypass Grafting The SWEDEGRAFT Right-Heart-Substudy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 31, 2022

Detailed Description

Complete study protocol attached

Interventions

  • Diagnostic Test: Echocardiography
    • Full 2D and 3D echocardiography with special focus on right ventricular function

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aarhus University Hospital Skejby
  • Collaborator
    • Uppsala University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ivy susanne Modrau, MD, Consultant Cardiac Surgeon, Associate Professor – Aarhus University Hospital Skejby
  • Overall Official(s)
    • Ivy Modrau, MD, dr.med., Principal Investigator, Aarhus University Hospital Skejby

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.