This study will test the hypothesis that acute preoperative administration of statins will offer a better protection against MIRI than long term preoperative administration does.
ID
Bron
Verkorte titel
Aandoening
Cardiac surgery, postoperative inflammation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Inflammatory response (IL-6, CRP);<br>
2. Myocardial damage (troponin);<br>
3. Pathophysiology of ischemia/reperfusion injury.
Achtergrond van het onderzoek
Medical research has shown that statins, in addition to their effects on the cholesterol metabolism, also have an anti-inflammatory effect. During cardiac surgery, the difference in protection between acute and long term administration of statins will be measured using myocardial ischemia reperfusion injury markers.
Doel van het onderzoek
This study will test the hypothesis that acute preoperative administration of statins will offer a better protection against MIRI than long term preoperative administration does.
Onderzoeksopzet
1. Treatment: Acute or chronic (See above);
2. Blood samples will be drawn the day patients visit our clinic until 5 days after surgery.
Onderzoeksproduct en/of interventie
After giving informed consent patients will be randomized into:
1. Acute treatment: One dose of 40 mg simvastatin the evening before and one dose of 40 mg simvastatine the morning before surgery;
2. Long term treatment: 40 mg simvastatine for a minimum of 2 weeks prior to surgery.
Algemeen / deelnemers
Dpt. of Vascular Surgery.<br>
PO-box 9600
Jan H. Lindeman
Leiden 2300 RC
The Netherlands
Lindeman@lumc.nl
Wetenschappers
Dpt. of Vascular Surgery.<br>
PO-box 9600
Jan H. Lindeman
Leiden 2300 RC
The Netherlands
Lindeman@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Acceptation for mitral/tricuspid valve surgery via sternotomy.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Statine use;
2. Acceptation for minimal invasive surgery;
3. Ablation or CABG procedures;
4. Emergency operations;
5. Clinically diagnosed heart failure or atherosclerosis;
6. Use of corticosteroids.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2555 |
| NTR-old | NTR2673 |
| Ander register | METC LUMC : P10.083 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Samenvatting resultaten
Bulhak et al. Am J Physio Heart Circ Physiol 2007.<br>
Birnbaum et al. J Cardiovasc Pharmacol Ther 2008.<br>
Mensah et al. J Am Coll Cardiol 2005.<br>
Liakopoulos et al. Thorac Cardiov Surg 2006.