The SWEDEGRAFT Right-Heart-Substudy

Status Completed

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.

Clinical Trial Description

Complete study protocol attached ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05049421
Study type	Observational
Source	Aarhus University Hospital Skejby
Contact
Status	Completed
Phase
Start date	August 10, 2021
Completion date	October 31, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05139108` - TEE Monitoring and the Incidence of Postoperative Acute Kidney Injury in Coronary Artery Bypass Grafting
Completed	`NCT04523064` - POST-CABGDM: Empagliflozin in Perioperative CABG	Phase 4
Not yet recruiting	`NCT05540249` - Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG	N/A
Completed	`NCT01467232` - IMPACT-CABG Trial: IMPlantation of Autologous CD133+ sTem Cells in Patients Undergoing Coronary Artery Bypass Grafting	Phase 2
Completed	`NCT04631809` - Computed Tomography Coronary Angiography in Patients With a Previous Coronary Artery Bypass Graft Surgery Trial	N/A
Completed	`NCT00073580` - Angiomax in Patients With HIT/HITTS Type II Undergoing Off-Pump Coronary Artery Bypass Grafting (CABG) (CHOOSE)	Phase 3
Terminated	`NCT03346278` - Text Message Intervention to Improve Cardiac Rehab Participation	N/A
Completed	`NCT00303641` - Safety and Effectiveness of the Medtronic Resting Heart Bypass System in Heart Surgery Patients	Phase 1
Completed	`NCT03823521` - Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™	Phase 3
Terminated	`NCT00789399` - A Study of the Efficacy of Preventive Dosing of Fondaparinux Sodium Versus Placebo for the Prevention of Venous Thromboembolism (VTE) in Patients Undergoing Coronary Bypass Surgery Receiving Routine Mechanical Prophylaxis	N/A
Completed	`NCT02592824` - Glutamate for Metabolic Intervention in Coronary Surgery II	Phase 3
Not yet recruiting	`NCT05079724` - Acute Kidney Injury After Cardiac Surgery
Withdrawn	`NCT04379947` - Preoperative Use of Fractional Flow Reserve in CABG Use and Effectiveness of FFR-based CABG in Real-life Practice
Terminated	`NCT00858936` - Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass Graft Surgery	Phase 2
Recruiting	`NCT01386229` - A Comparison of Etomidate and Ketamine for Anesthesia Induction in Coronary Artery Bypass Graft Surgery	Phase 4
Completed	`NCT00653042` - Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA	Phase 2
Completed	`NCT00318227` - Randomized Trial of a Liberal Versus a Restrictive Transfusion Strategy in Elderly Cardiac Surgery Patients	N/A
Completed	`NCT00372671` - Evaluation of an Introductory Videotape Intervention to Improve Cardiac Rehabilitation Participation	Phase 3
Completed	`NCT00209521` - Comparison of AQUAVAN® Injection to DISOPRIVAN® Injectable Emulsion for Anesthesia During Coronary Artery Surgery	Phase 2
Not yet recruiting	`NCT05396690` - Safety and Efficacy of Remimazolam in OPCAB Surgery	N/A