Coronary Heart Disease, Multi Vessel Coronary Artery Disease
Conditions
Keywords
CABG, Coronary Artery Bypass Grafting
Brief summary
The study is a voluntary study, initiated by B. Braun to collect clinical data for Optilene® suture concerning its key indication.
Detailed description
Coronary artery bypass graft (CABG) surgery is one of the most common elective surgical procedure. In total 40.000 CABG´s have been performed yearly in Germany in 2012 and 2013 which presents 60% of all cardiac surgical interventions. Coronary artery bypass grafting is performed for patients with coronary artery disease (CAD) to improve quality of life and to reduce cardiac-related mortality. CAD is the most leading cause of mortality in the Western world as well as in developing countries and it is the most common cause of heart failure. CABG was introduced in the 1960s. CABG operation has become the most studied intervention in the history of surgery. It is highly effective in the treatment of severe angina and it delays unfavorable events such as death, myocardial infarction and recurrence of angina in comparison to other treatment forms. There is a general agreement that already in the early postoperative period CABG surgery improves the disease in patients with symptomatic left main coronary artery stenosis or stenosis of the three main coronary vessels.
Interventions
PROCEDURECoronary Artery Bypass Graft surgery
Sponsors
B.Braun Surgical SA
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing an elective primary coronary artery bypass graft surgery (CABG). * On pump or off pump CABG surgery * Age ≥25 years * Written informed consent
Exclusion criteria
* Emergency surgery * Insulin dependent Diabetes Mellitus * Acute myocardial infarction with Creatinine Kinase-MB level \> 10% of CK and /or ECG signs * Known immunodeficiency or immunosuppression * Other combined aortic valve intervention except cardiac valve or mitral valve surgery * Participation or planned participation in another cardiovascular study before study follow-up is completed. * Inability to give informed consent due to mental condition, mental retardation, or language barrier.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative CABG adverse events in hospital | day of discharge (average 7 to 10 days) | Incidence of individual postoperative CABG adverse events in hospital. Postoperative CABG adverse events are defined as the sum of the frequency of myocardial infarction, stroke, mortality, renal failure and gastrointestinal bleeding. |
Secondary
| Measure | Time frame |
|---|---|
| Mortality | until day of discharge (average 7 to 10 days), 30 days and 3 months postop |
| Gastrointestinal bleeding | until day of discharge (average 7 to 10 days) |
| Incidence of renal failure | until day of discharge (average 7 to 10 days) |
| Anastomosis revision rate due to rebleeding | until day of discharge (average 7 to 10 days) |
| Other adverse events (wound infection, angina, reoperation) | until 3 months postop |
| Incidence of myocardial infarction (MI) | until day of discharge (average 7 to 10 days), 30 days and 3 months postop |
| Incidence of stroke | until day of discharge (average 7 to 10 days), 30 days and 3 months postop |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of the postoperative hospital stay | Until discharge (average 7 to 10 days) | — |
| Improvement of Quality of life Score (EQ-5D-5L) | 3 months postop | — |
| Repeat Revascularization | until 1 and 3 months postop | Incidence of repeat revascularization leading to CABG or Percutaneous Coronary Intervention (PCI) |
| Handling of the suture material | at time of surgery | Handling of the suture material using a questionnaire containing different dimension and a 5 point assessment level (Likert Scale) |
Countries
Germany, Italy, Portugal, Spain
Outcome results
None listed