Coronary Artery Bypass SurgeryNCT05049421
The SWEDEGRAFT Right-Heart-Substudy
An observational study of Coronary Artery Bypass Surgery and Right-Sided Heart Failure, run by Aarhus University Hospital Skejby at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Coronary Artery Bypass Surgery, Right-Sided Heart Failure
- What is being tested?
- Echocardiography
- How many people
- 207 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Aug 2021to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Right Ventricular Function After Coronary Artery Bypass Grafting The SWEDEGRAFT Right-Heart-Substudy
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.
Read more
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.
Read the detailed description
Complete study protocol attached
- Being tested
- Echocardiography
- Keywords
- 2-D Echocardiography, 3-D Echocardiography, Coronary Artery Bypass Surgery, Right-Sided Heart Failure, Patient Reported Outcome Measures
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Full 2D and 3D echocardiography with special focus on right ventricular function
| Study group | Role | What they receive |
|---|---|---|
| Patients following CABG | Recruitment amongst patients enrolled in SWEDEGRAFT RCT at Aarhus University Hospital scheduled for follow-up Receives: Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D right ventricular ejection fraction
Right ventricular function assessed by 3D echocardiography
Measured: 30 months postoperative
Right ventricular strain
Derived from two-dimensional speckle-tracking
Measured: 30 months postoperative
Secondary outcomes (5)
Disease-specific health-related quality of life
Seattle Angina Questionnaire-7
-> 0 denotes the worst and 100 the best possible health status
Measured: 30 months postoperative
Degree of dyspnea at exertion
NYHA class
Measured: 30 months postoperative
Perceived exertion during exercise
Borg CR10® Scale
-> Range from 0: No exertion to 10: Maximal level of exertion
Measured: 30 months postoperative
Pro-Brain Natriuretic Peptide
pg/mL
Measured: 30 months postoperative
Long-term Major Adverse Cardiac and Cerebrovascular Events
all-cause mortality, myocardial infarction, repeat hospitalization due to cardiac cause, cerebrovascular accident, repeat revascularization
Measured: 5 and 10 years after CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start10 Aug 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Responsible party
- Principal investigator, Ivy susanne Modrau, MD, Aarhus University Hospital Skejby
- Investigators
- Ivy Modrau, MD, dr.med., Principal investigator, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049421
- Sponsor's protocol ID
- 1-10-72-207-18-2
- Status last verified
- Aug 2023
- First submitted
- 10 Sep 2021
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32272256
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Function After Coronary Artery Bypass Grafting The SWEDEGRAFT Right-Heart-Substudy
- ClinicalTrials.gov ID
- NCT05049421
- Acronym / sponsor ID
- 1-10-72-207-18-2
- Keywords
- 2-D Echocardiography, 3-D Echocardiography, Coronary Artery Bypass Surgery, Right-Sided Heart Failure, Patient Reported Outcome Measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients following CABG | – | Diagnostic Test: EchocardiographyRecruitment amongst patients enrolled in SWEDEGRAFT RCT at Aarhus University Hospital scheduled for follow-up |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyFull 2D and 3D echocardiography with special focus on right ventricular function | Diagnostic test | Patients following CABG |
Primary outcome
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
5 secondary outcomes
Disease-specific health-related quality of life
Time frame: 30 months postoperative
Degree of dyspnea at exertion
Time frame: 30 months postoperative
Perceived exertion during exercise
Time frame: 30 months postoperative
Pro-Brain Natriuretic Peptide
Time frame: 30 months postoperative
Long-term Major Adverse Cardiac and Cerebrovascular Events
Time frame: 5 and 10 years after CABG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Background: PubMed 32272256Ragnarsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivy Modrau, MD, dr.med. principal investigator
Aarhus University Hospital Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Bypass Surgery and Right-Sided Heart Failure, run by Aarhus University Hospital Skejby at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D right ventricular ejection fraction (time frame: 30 months postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05049421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.