Comparison of two cardiac protection techniques during cardiac surgery
- Conditions
- Medical conditions necessitating an elective surgical coronary arterybypass grafting (CABG) and/or a valve repair/replacement.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-004198-10-AT
- Lead Sponsor
- Swiss Cardio Technologies AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 264
1. Male or female patients between 18 and 80 years of age.
2. The patient’s preoperative evaluation indicates the need for a primary elective cardiac coronary artery bypass graft (CABG) operation and/or a cardiac valve repair/replacement;
3. The operation can be carried out via a full sternotomy, under cardiac arrest and under the assistance of a heart lung machine;
4. Patients (or legal representatives) who provide signed written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. pre-operative EF of less than 30%;
2. pre-operative IABP;
3. under pre-operative catecholamine support;
4. history of myocardial infarction within less than 7 days;
5. previous history of cardiac surgery, including the implantation of a pace maker or an ICD;
6. active myocarditis and/or endocarditis;
7. history of atrial fibrillation;
8. aortic valve insufficiency severity grade > 1;
9. history of neurologic event;
10. carotid artery disease;
11. renal insufficiency or is under dialysis;
12. pre-operative serum creatinine value of more than 2.0 mg/dl;
13. known for an hematologic disorder;
14. under anti-vitamin K;
15. history of HIT;
16. participating in a concomitant research study of an investigational product;
17. pregnant or lactating;
18. intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Maximal value of troponin-T (ng/ml) during the first 24 hours following myocardial reperfusion.;Timepoint(s) of evaluation of this end point: During the first 24 hours post-reperfusion ;Main Objective: To explore the effects of CardioplexolTM on the protection of cardiac cells during the ischemic” period in order to allow a rapid and complete reversibility of the cardiac arrest when used during a cardiac surgical intervention under the assistance of a heart-lung machine.;Secondary Objective: - To explore the effects on duration in ICU stay and on duration of hospitalisation<br>- To evaluate the safety and tolerability of CardioplexolTM<br>
- Secondary Outcome Measures
Name Time Method