Pharmacological Postconditioning During the Aortic Valvular Surgery
PC Pharma CVA
1 other identifier
interventional
56
1 country
1
Brief Summary
Primary objective: To evaluate the efficacy of the cyclosporin A administration to induce a cardioprotection during the valvular surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 29, 2009
CompletedFirst Posted
Study publicly available on registry
September 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedMay 28, 2019
November 1, 2011
1.9 years
September 29, 2009
May 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The peak of the cardiac troponin I blood level measured during the first 72 hours of surgery follow-up.
72 hours
Secondary Outcomes (1)
Area under curve of the cardiac troponin I release, BNP, length of mechanical ventilation, length of stay in ICU, SAPS, necessity of a catecholaminergic support to assure hemodynamic stability, SAE
72 hours
Study Arms (2)
cyclosporine
EXPERIMENTALA single bolus of 2.5 mg/kg cyclosporine is administered before aortic cross-declamping
Control
OTHERNo cyclosporine A is administered before aortic cross-declamping
Interventions
a single bolus of 2.5 mg/kg, administered before aortic cross-declamping
Eligibility Criteria
You may qualify if:
- Male or females, scheduled for an aortic valvular surgery;
- years of age or older.
You may not qualify if:
- Combined valvular and coronary surgery;
- Significant coronary artery stenosis (upper than 70%);
- Left ventricular dysfunction (ejection fraction \< 40%);
- Emergency surgery and/or infectious endocarditis;
- Known cyclosporin hypersensitivity;
- History of known recent immunosuppression (\< 6 months): cancer, lymphoma, positive serology for HIV, hepatitis;
- Renal insufficiency (creatininaemia \> 150 µmol/l);
- Hepatic insufficiency (prothrombin time \< 50%);
- Uncontrolled arterial hypertension defined by a systolic arterial pressure \> 180 mm Hg;
- Women of child bearing potential, who are pregnant or not under efficient contraception;
- Patients treated with nicorandil, sulfonylurea or rosuvastatine;
- Patients under judicial control.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Louis Pradel
Lyon, 69394, France
Related Publications (1)
Chiari P, Angoulvant D, Mewton N, Desebbe O, Obadia JF, Robin J, Farhat F, Jegaden O, Bastien O, Lehot JJ, Ovize M. Cyclosporine protects the heart during aortic valve surgery. Anesthesiology. 2014 Aug;121(2):232-8. doi: 10.1097/ALN.0000000000000331.
PMID: 25050491RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pascal CHIARI, MD
Hospices Civils de Lyon, France
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2009
First Posted
September 30, 2009
Study Start
October 1, 2008
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
May 28, 2019
Record last verified: 2011-11