Effect of N-acetylcystein in Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01741207
• Other study ID #: 524
• Secondary ID: IRCT201210118698
• Status: Unknown status
• Phase: Phase 3
• First received: November 30, 2012
• Last updated: November 30, 2012
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: November 2012
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• N-acetylcystein
Active Comparator: N-acetylcystein receive N-acetylcystein in addition to standard treatment

Locations

Country	Name	City	State
Iran, Islamic Republic of	Teran Heart Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers of platelet activation (P selectin- CD40L-IL[Interleukin] 10- TGF[Transforming Growth Factor]-beta)		Change from the baseline after 24 hours
Secondary	Cardiac Necrosis Biomarkers (CKMB, Troponin T)	difference between study and control group in 6 and 12 hrs after percutaneous coronary intervention	Change from the baseline after 12 hours
Secondary	score of coronary blood flow(TIMI flow and MBG)		Change from the baseline after percutaneous coronary intervention
Secondary	MACE (Major Adverse Cardiac Effect)	Defined as Need for Target Revascularization, Myocardial Infarction and Death	30 days