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Ciclosporin A and Acute Myocardial Infarction

Primary Purpose

Myocardial Infarction

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
ciclosporine A
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Ischemia, Reperfusion, Myocardial infarction, ciclosporin A, acute myocardial infarction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female patients, aged more than 18, with suspected first acute myocardial infarction
  • Within 12 hours of the onset of chest pain
  • With a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow >2 after direct stenting by angioplasty.

Exclusion Criteria:

  • Hypersensibility to ciclosporine A
  • Cardiac arrest or cardiogenic shock
  • Immunosuppressive disease (< 6 months): cancers, lymphomas, positive serology for HIV, hepatitis, etc.
  • Known renal failure or serum creatinine > 120 µmole/l at admission
  • Liver failure
  • Uncontrolled hypertension
  • Current pregnancy or women without contraception

Sites / Locations

  • Michel Ovize

Outcomes

Primary Outcome Measures

Infarct size evaluated primarily by the area under the curve of CK and troponin I release over the first 72 hours of reperfusion.

Secondary Outcome Measures

Myocardial contractile reserve assessed by dobutamine echocardiography at day 5.
No reflow evaluated by MRI at day 5
Recovery of myocardial contraction assessed by echocardiography and MRI at month 3

Full Information

First Posted
November 24, 2006
Last Updated
April 26, 2007
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT00403728
Brief Title
Ciclosporin A and Acute Myocardial Infarction
Official Title
Protection by Ciclosporine A During Reperfused Acute Myocardial Infarction.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

5. Study Description

Brief Summary
Beyond its immunosuppressive properties, ciclosporine A (CsA) can also inhibit the opening of a mitochondrial mega-channel called the permeability transition pore (mPTP). Opening of the mPTP plays a key role in cardiomyocyte death during reperfusion following a prolonged ischemic insult. Ciclosporin A has been shown to reduce infarct size when administered at reperfusion in experimental models. The objective of the present study is to determine whether administration of CsA at reperfusion in patients with ongoing acute myocardial infarction treated by coronary angioplasty might reduce infarct size.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Ischemia, Reperfusion, Myocardial infarction, ciclosporin A, acute myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ciclosporine A
Primary Outcome Measure Information:
Title
Infarct size evaluated primarily by the area under the curve of CK and troponin I release over the first 72 hours of reperfusion.
Secondary Outcome Measure Information:
Title
Myocardial contractile reserve assessed by dobutamine echocardiography at day 5.
Title
No reflow evaluated by MRI at day 5
Title
Recovery of myocardial contraction assessed by echocardiography and MRI at month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients, aged more than 18, with suspected first acute myocardial infarction Within 12 hours of the onset of chest pain With a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow >2 after direct stenting by angioplasty. Exclusion Criteria: Hypersensibility to ciclosporine A Cardiac arrest or cardiogenic shock Immunosuppressive disease (< 6 months): cancers, lymphomas, positive serology for HIV, hepatitis, etc. Known renal failure or serum creatinine > 120 µmole/l at admission Liver failure Uncontrolled hypertension Current pregnancy or women without contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Ovize, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michel Ovize
City
Lyon
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20298926
Citation
Mewton N, Croisille P, Gahide G, Rioufol G, Bonnefoy E, Sanchez I, Cung TT, Sportouch C, Angoulvant D, Finet G, Andre-Fouet X, Derumeaux G, Piot C, Vernhet H, Revel D, Ovize M. Effect of cyclosporine on left ventricular remodeling after reperfused myocardial infarction. J Am Coll Cardiol. 2010 Mar 23;55(12):1200-1205. doi: 10.1016/j.jacc.2009.10.052.
Results Reference
derived

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Ciclosporin A and Acute Myocardial Infarction

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