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| Name | Class |
|---|---|
| Uppsala University | OTHER |
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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.
Complete study protocol attached
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients following CABG | Recruitment amongst patients enrolled in SWEDEGRAFT RCT at Aarhus University Hospital scheduled for follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiography | Diagnostic Test | Full 2D and 3D echocardiography with special focus on right ventricular function |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Degree of dyspnea at exertion |
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Inclusion Criteria:
SWEDEGRAFT inclusion criteria:
Additional inclusion criteria for the Right-Heart-Substudy:
• Ability to meet for follow-up visit
Exclusion Criteria:
SWEDEGRAFT exclusion criteria:
Additional inclusion criteria for the Right-Heart-Substudy:
• Inability to cooperate to transthoracic echocardiography
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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
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| Name | Affiliation | Role |
|---|---|---|
| Ivy Modrau, MD, dr.med. | Aarhus University Hospital Skejby | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital Skejby | Aarhus | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32272256 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 10, 2020 | Nov 18, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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NYHA class
| 30 months postoperative |
| Perceived exertion during exercise | Borg CR10® Scale -> Range from 0: No exertion to 10: Maximal level of exertion | 30 months postoperative |
| Pro-Brain Natriuretic Peptide | pg/mL | 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 | 5 and 10 years after CABG |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |