Effect of N-acetylcystein in Myocardial Infarction

November 30, 2012 updated by: Tehran University of Medical Sciences

Evaluation of N-acetylcystein on Biomarkers of Platelet Activation , Cardiac Necrosis and Coronary Reperfusion in Patients Undergoing Percutaneous Coronary Intervention

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

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

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 1711713138
        • Recruiting
        • Teran Heart Center
        • Contact:
        • 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

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • EXI-NACE,NAC

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from the baseline after 12 hours
score of coronary blood flow(TIMI flow and MBG)
Time Frame: Change from the baseline after percutaneous coronary intervention
Change from the baseline after percutaneous coronary intervention
MACE (Major Adverse Cardiac Effect)
Time Frame: 30 days
Defined as Need for Target Revascularization, Myocardial Infarction and Death
30 days

Collaborators and Investigators

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

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Azita Hajhossein Talasaz, PharmD,BCPS, Tehran University of Medical Sciences

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

January 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

December 4, 2012

Last Update Submitted That Met QC Criteria

November 30, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 524
  • IRCT201210118698N2 (Registry Identifier: IRCT)

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.

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