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

May 23, 2019 updated by: Hospices Civils de Lyon
Primary objective: To evaluate the efficacy of the cyclosporin A administration to induce a cardioprotection during the valvular surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69394
        • Hopital Louis Pradel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cyclosporine
A single bolus of 2.5 mg/kg cyclosporine is administered before aortic cross-declamping
Drug: cyclosporine A
a single bolus of 2.5 mg/kg, administered before aortic cross-declamping
Other: Control
No cyclosporine A is administered before aortic cross-declamping
Other: No injection
No cyclosporine A is administered before aortic cross-declamping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The peak of the cardiac troponin I blood level measured during the first 72 hours of surgery follow-up.
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Pascal CHIARI, MD, Hospices Civils de Lyon, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (Estimate)

September 30, 2009

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007.490

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aortic Valvular Surgery

Clinical Trials on cyclosporine A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe