Coronary Artery Bypass Clinical Trial
Official title:
Inflammatory Response and Clinical Outcome After On-pump Beating Coronary Artery Bypass Grafting Using Left Ventricular Assist Versus Biventricular Assist in Patients With Severe Left Ventricle Dysfunction
Verified date | March 2021 |
Source | Henan Institute of Cardiovascular Epidemiology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators designed the randomized prospective study to evaluate the differences of inflammatory response and clinical outcome after on-pump beating coronary artery bypass grafting undergoing left ventricular assist versus biventricular assist in patients with severe left ventricle dysfunction.
Status | Active, not recruiting |
Enrollment | 70 |
Est. completion date | October 2023 |
Est. primary completion date | October 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients with severe left ventricle dysfunction with an ejection fraction (EF)=40%, being scheduled for revascularization. Exclusion Criteria: - myocardial infarction within the preceding 4 weeks - severe valve disease requiring valve replacement - cardiac reoperations |
Country | Name | City | State |
---|---|---|---|
China | Henan Provincial People' Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Henan Institute of Cardiovascular Epidemiology |
China,
Al Jaaly E, Chaudhry UA, Harling L, Athanasiou T. Should we consider beating-heart on-pump coronary artery bypass grafting over conventional cardioplegic arrest to improve postoperative outcomes in selected patients? Interact Cardiovasc Thorac Surg. 2015 — View Citation
Erkut B, Dag O, Kaygin MA, Senocak M, Limandal HK, Arslan U, Kiymaz A, Aydin A, Kahraman N, Calik ES. On-pump beating-heart versus conventional coronary artery bypass grafting for revascularization in patients with severe left ventricular dysfunction: ear — View Citation
Ferrari E, Stalder N, von Segesser LK. On-pump beating heart coronary surgery for high risk patients requiring emergency multiple coronary artery bypass grafting. J Cardiothorac Surg. 2008 Jul 2;3:38. doi: 10.1186/1749-8090-3-38. — View Citation
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Fujii T, Watanabe Y, Shiono N, Kawasaki M, Yokomuro H, Ozawa T, Hamada S, Masuhara H, Teramoto T, Hara M, Katayanagi T, Sasaki Y, Koyama N. Assessment of on-pump beating coronary artery bypass surgery performed after introduction of off-pump approach. Ann — View Citation
Gulcan O, Turkoz R, Turkoz A, Caliskan E, Sezgin AT. On-pump/beating-heart myocardial protection for isolated or combined coronary artery bypass grafting in patients with severe left ventricle dysfunction: assessment of myocardial function and clinical ou — View Citation
Lim E, Drain A, Davies W, Edmonds L, Rosengard BR. A systematic review of randomized trials comparing revascularization rate and graft patency of off-pump and conventional coronary surgery. J Thorac Cardiovasc Surg. 2006 Dec;132(6):1409-13. Review. — View Citation
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Stassano P, Di Tommaso L, Monaco M, Iesu S, Brando G, Buonpane S, Ambrosio G, Di Benedetto G, Pepino P. Myocardial revascularization by left ventricular assisted beating heart is associated with reduced systemic inflammatory response. Ann Thorac Surg. 200 — View Citation
Urso S, Sadaba JR, Pettinari M. Impact of off-pump to on-pump conversion rate on post-operative results in patients undergoing off-pump coronary artery bypass. Interact Cardiovasc Thorac Surg. 2012 Feb;14(2):188-93. doi: 10.1093/icvts/ivr071. Epub 2011 No — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes of C-reactive protein (CRP) | Serial blood samples for inflammatory response of CRP were collected at the following time points: 1: induction of anesthesia, 2: upon termination of cardiopulmonary bypass (CPB), 3: 6 hours postoperatively, 4: 24 hours postoperatively, 5: 48 hours postoperatively, 6: 72 hours postoperatively. | up tp 72 hours | |
Secondary | Incidence of atrial fibrillation | from ICU admission to discharge | 10 days | |
Secondary | Durations of mechanical ventilation | 10 days | ||
Secondary | The number for transfused packed red cells | measured by milliliter from ICU admission to discharge | up to 10 days | |
Secondary | Partial oxygen pressure/inspired oxygen fraction (P/F) | up tp 10 days | ||
Secondary | Cardiac Troponin I (cTnI) | Serial blood samples for cTnI were collected at the following time points: 1: induction of anesthesia, 2: upon termination of CPB, 3: 6 hours postoperatively, 4: 24 hours postoperatively, 5: 48 hours postoperatively, 6: 72 hours postoperatively. | up to72 hours | |
Secondary | In-hospital mortality | from ICU admission to discharge | up to 10 days |
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