E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Improvement of cardioprotection during elective coronary artery bypass graft surgery using the patients own bone marrow cells. |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate in a randomised, double-blinded study whether the administration of autologous bone marrow cells as an additive to cardioplegia reduces myocardial ischaemic injury during cardiac surgery. |
|
E.2.2 | Secondary objectives of the trial |
To study whether the administration of autologous BMCs improves cardiac function during the early period following cardiac surgery. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Triple vessel coronary artery disease with or without significant disease of the left main stem with indication of elective surgical revascularization • Left ventricular ejection fraction greater than 40% • Age 20-80 years
|
|
E.4 | Principal exclusion criteria |
In addition to not being compliant to the inclusion criteria, the following criteria will be sufficient to exclude patients from entering the study: • Cardiogenic shock (need for inotropic drugs, intra-aortic balloon pump) • Previous CABG • PCI in the previous 3 months • History of neoplastic disease • History of bleeding disorder • Chronic inflammatory disease • Active infection • Renal impairment (creatinine >180mmol/l) • Liver dysfunction (GOT >2xULN or INR >1.5) • Diabetes • Chronic treatment with oral antibiotic agents
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary end-point of the study will be a reduction in the plasma levels of the cardiac enzyme troponin I by more than 10% in the BMCs-treated groups. In vitro studies in our laboratory using human atrial myocardium and autologous BMCs have shown that CK release after 90 minutes of simulated ischaemia and 120 minutes of reoxygenation is reduced by more than 50% of the values seen in controls. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The participation of individuals will finish when they are discharged from hospital following their cardiac surgery operation. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |