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Effect of N-acetylcystein in Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT01741207
Recruitment Status : Unknown
Verified November 2012 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Study Description
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Brief Summary:
We designed this study to evaluate the effect of N-acetylcystein on biomarkers of platelet activation , cardiac necrosis and coronary reperfusion in patients undergoing percutaneous coronary intervention.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: N-acetylcystein Phase 3

Detailed Description:

Percutaneous coronary intervention(PCI) is one of the standard therapies for acute coronary syndrome. Despite major advances in PCI procedure, impaired myocardial perfusion frequently occurred after primary PCI and resulted in a larger infarct size and increased morbidity and mortality.Reperfusion injury process can be resulted in additional death of cardiomyocytes and it is suggested that oxidative stress is a contributing factor to induce reperfusion injury.During PCI,trauma occurs to the arterial endothelium, causes the activation and aggregation of platelets.

It is estimated that approximately 25% of patients undergoing PCI have significant postprocedural creatinine kinase (CK)/creatinine kinase myocardial band (CK-MB) elevations and approximately 50% of patients have significant post-procedural troponin elevations. The most common complication of PCI is a cell damage to cardiomyocyte that can be diagnosed by postprocedure elevation of cardiac markers. N-acetylcystein have several positive effect on platelet and vascular function and infarct size.

This study is a randomized clinical trial (RCT) evaluating the effect of N-acetylcystein on biomarkers of platelet activation and coronary reperfusion in patients undergoing percutaneous coronary intervention. Double blind randomized clinical trial on 100 patients in 2 groups (intervention & control) is conducted. Patients with confirmed ST-elevation myocardial infarction included in this study. Patients were excluded if they had: emergency for cardiac bypass; cardiogenic shock and rescue percutaneous coronary intervention. Patients in Intervention group were administered 100 mg/kg Iv bolus N-acetylcystein and then 480mg intracoronary and 10mg/kg/h over 12 hours after percutaneous coronary intervention and patients in control group received standard regimens. Primary outcome was platelet activation biomarkers assessment before and 24 hours after percutaneous coronary intervention and secondary outcome was effect of N-acetylcystein on CK-MB and high sensitive Troponin T, 6 and 12 hours after percutaneous coronary intervention.Patients were assessed for coronary blood flow after percutaneous coronary intervention with the use of TIMI flow and myocardial blush grade.

Major adverse cardiac events (MACE) will be evaluated as a secondary endpoint after 30 days.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of N-acetylcystein on Biomarkers of Platelet Activation , Cardiac Necrosis and Coronary Reperfusion in Patients Undergoing Percutaneous Coronary Intervention
Study Start Date : January 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
No Intervention: control
control This group is without N-acetylcystein : just receives standard treatment
Active Comparator: N-acetylcystein
receive N-acetylcystein in addition to standard treatment Ampoule 200 mg/ml
 Drug: N-acetylcystein
Active Comparator: N-acetylcystein receive N-acetylcystein in addition to standard treatment
Other Name: EXI-NACE,NAC


Outcome Measures
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Primary Outcome Measures :
  1. Biomarkers of platelet activation (P selectin- CD40L-IL[Interleukin] 10- TGF[Transforming Growth Factor]-beta) [ Time Frame: Change from the baseline after 24 hours ]

Secondary Outcome Measures :
  1. Cardiac Necrosis Biomarkers (CKMB, Troponin T) [ Time Frame: Change from the baseline after 12 hours ]
    difference between study and control group in 6 and 12 hrs after percutaneous coronary intervention

  2. score of coronary blood flow(TIMI flow and MBG) [ Time Frame: Change from the baseline after percutaneous coronary intervention ]
  3. MACE (Major Adverse Cardiac Effect) [ Time Frame: 30 days ]
    Defined as Need for Target Revascularization, Myocardial Infarction and Death


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Myocardial infarction patients who were candidate of primary PCI

Exclusion Criteria:

  • Rescue PCI
  • Emergency for cardiac bypass
  • Cardiogenic shock
  • Life expectancy less than 6 months
  • Age less than 18 years old
  • Uncontrolled hypertension
  • Thrombocytopenia
  • Malformation or aneurysm
  • Sever chronic kidney disease
  • Sever liver failure
  • Major surgery within 3 months
  • Unsatisfactory to enter the study
Contacts and Locations
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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): NCT01741207


Locations
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Iran, Islamic Republic of
Teran Heart Center Recruiting
Tehran, Iran, Islamic Republic of, 1711713138
Contact: Azita Hajhossein Talasaz    00989123779707    atalasaz@razi.tums.ac.ir   
Principal Investigator: Azita Hajhossein Talasaz, PharmD,BCPS         
Sub-Investigator: Yaser Jenab, MD         
Sub-Investigator: Mossafa Bahremand, MD         
Sub-Investigator: Azadeh Eshraghi, Pharm D         
Principal Investigator: Jamshid Salamzadeh, PhD         
Sub-Investigator: Mojtaba Salarifard, MD         
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Principal Investigator: Azita Hajhossein Talasaz, PharmD,BCPS Tehran University of Medical Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01741207    
Other Study ID Numbers: 524
IRCT201210118698N2 ( Registry Identifier: IRCT )
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases