Ciclosporin A and Acute Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00403728
First received: November 24, 2006
Last updated: April 26, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Drug: ciclosporine A
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Protection by Ciclosporine A During Reperfused Acute Myocardial Infarction.

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

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

Estimated Enrollment: 60
Study Start Date: September 2004
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403728

Locations
France
Michel Ovize
Lyon, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Michel Ovize, MD Hospices Civils de Lyon
  More Information

No publications provided by Hospices Civils de Lyon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00403728     History of Changes
Other Study ID Numbers: 2004.353
Study First Received: November 24, 2006
Last Updated: April 26, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Ischemia
Reperfusion
Myocardial infarction
ciclosporin A
acute myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 14, 2014