We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacological Postconditioning During the Aortic Valvular Surgery (PC Pharma CVA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00987207
First Posted: September 30, 2009
Last Update Posted: November 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose
Primary objective: To evaluate the efficacy of the cyclosporin A administration to induce a cardioprotection during the valvular surgery.

Condition Intervention Phase
Aortic Valvular Surgery Drug: cyclosporine A Other: No injection Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pharmacological Postconditioning During the Aortic Valvular Surgery

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • The peak of the cardiac troponin I blood level measured during the first 72 hours of surgery follow-up. [ Time Frame: 72 hours ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 72 hours ]

Enrollment: 56
Study Start Date: October 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cyclosporine
a single bolus of 2.5 mg/kg, administered before aortic cross-declamping
Drug: cyclosporine A
a single bolus of 2.5 mg/kg, administered before aortic cross-declamping
No Intervention: Control
No cyclosporine A is administered before aortic cross-declamping
Other: No injection
No cyclosporine A is administered before aortic cross-declamping.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or females, scheduled for an aortic valvular surgery;
  • 18 years of age or older.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987207


Locations
France
Hôpital Louis Pradel
Lyon, France, 69394
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Pascal CHIARI, MD Hospices Civils de Lyon - France
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00987207     History of Changes
Other Study ID Numbers: 2007.490
First Submitted: September 29, 2009
First Posted: September 30, 2009
Last Update Posted: November 9, 2011
Last Verified: November 2011

Keywords provided by Hospices Civils de Lyon:
Postconditioning
cyclosporine A
myocardial ischemia
cardiac surgery
aortic valvulopathy

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors