The SWEDEGRAFT Right-Heart-Substudy

Coronary Artery Bypass Surgery Clinical Trial

Official title:

Right Ventricular Function After Coronary Artery Bypass Grafting The SWEDEGRAFT Right-Heart-Substudy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05049421
• Other study ID #: 1-10-72-207-18-2
• Status: Completed
• Start date: August 10, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: August 2023
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Complete study protocol attached

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Surgery
• Heart Failure
• Right-Sided Heart Failure

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital Skejby	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Uppsala University

Country where clinical trial is conducted

Denmark, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3D right ventricular ejection fraction	Right ventricular function assessed by 3D echocardiography	30 months postoperative
Primary	Right ventricular strain	Derived from two-dimensional speckle-tracking	30 months postoperative
Secondary	Disease-specific health-related quality of life	Seattle Angina Questionnaire-7; -> 0 denotes the worst and 100 the best possible health status	30 months postoperative
Secondary	Degree of dyspnea at exertion	NYHA class	30 months postoperative
Secondary	Perceived exertion during exercise	Borg CR10® Scale; -> Range from 0: No exertion to 10: Maximal level of exertion	30 months postoperative
Secondary	Pro-Brain Natriuretic Peptide	pg/mL	30 months postoperative
Secondary	Long-term Major Adverse Cardiac and Cerebrovascular Events	all-cause mortality, myocardial infarction, repeat hospitalization due to cardiac cause, cerebrovascular accident, repeat revascularization	5 and 10 years after CABG