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The POSITIVE (Pre-Operative STatin InterVEntion) study, preoperative statin intervention for valve surgery.


- candidate number8850
- NTR NumberNTR2673
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jan-2011
- Secondary IDsP10.083 METC LUMC
- Public TitleThe POSITIVE (Pre-Operative STatin InterVEntion) study, preoperative statin intervention for valve surgery.
- Scientific TitleThe POSITIVE (Pre-Operative STatin InterVEntion) study, preoperative statin intervention for valve surgery.
- ACRONYMPOSITIVE
- hypothesisThis study will test the hypothesis that acute preoperative administration of statins will offer a better protection against MIRI than long term preoperative administration does.
- Healt Condition(s) or Problem(s) studiedCardiac surgery, Postoperative inflammation
- Inclusion criteriaAcceptation for mitral/tricuspid valve surgery via sternotomy.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jan-2011
- planned closingdate15-jan-2013
- Target number of participants40
- InterventionsAfter 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.
- Primary outcome1. Inflammatory response (IL-6, CRP);
2. Myocardial damage (troponin);
3. Pathophysiology of ischemia/reperfusion injury.
- Secondary outcomeN/A
- Timepoints1. Treatment: Acute or chronic (See above);
2. Blood samples will be drawn the day patients visit our clinic until 5 days after surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD Jan H. Lindeman
- CONTACT for SCIENTIFIC QUERIESMD, PhD Jan H. Lindeman
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center, Department of Cardiothoracic Surgery
- PublicationsLudman et al. Pharmacology & Therapeutics 2009.
Bulhak et al. Am J Physio Heart Circ Physiol 2007.
Birnbaum et al. J Cardiovasc Pharmacol Ther 2008.
Mensah et al. J Am Coll Cardiol 2005.
Liakopoulos et al. Thorac Cardiov Surg 2006.
- Brief summaryMedical 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.
- Main changes (audit trail)
- RECORD3-jan-2011 - 11-jan-2011


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