Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein

Myocardial Infarction Clinical Trial

— LIPSIA-N-ACC  

Official title:

Trial to Compare Infarct Size and Occurrence of Contrast Dye Induced Nephropathy in Patients With Primary Percutaneous PCI in STEMI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00463749
• Other study ID #: 1111/2006
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2007
• Last updated: July 7, 2008
• Start date: December 2006
• Est. completion date: June 2008

Study information

• Verified date: July 2008
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Acetylcystein is a potent antioxidans which is able to prevent contrast dye induced nephropathy in stable patients undergoing additional hydration.

In primary percutaneous intervention for infarction hydration is not possible. Therefore Acetylcystein might prevent contrast dye induced nephropathy.

Furthermore, it might reduce infarct size as a result of its antioxidant properties.

Clinical trials are missing so far examining the effects of Acetylcystein on nephropathy and infarct size.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: June 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ST-elevation infarction (<12 hours)

• Angina

Exclusion Criteria:

• Prior fibrinolysis

• Dialysis

• Pregnancy

• Lactase-reduction

• Glucose-galactose malabsorption

• Known allergy to acetylcystein

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Kidney Diseases
• Myocardial Infarction

Intervention

Drug:
• Acetylcystein
high-dose N-Acetylcystein during PCI and for 2/day for 2 days
• Placebo
NaCl as placebo

Locations

Country	Name	City	State
Germany	University of Leipzig - Heart Center	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial salvage measured by magnetic resonance imaging		4 days	No
Primary	prevention of nephropathy		3 days	No
Secondary	ST-segment resolution		90 min	No
Secondary	TIMI flow		minutes	No
Secondary	composite clinical endpoint (death, reinfarction, congestive heart failure)		30 days	No
Secondary	need for dialysis		4 days	No
Secondary	microvascular obstruction measured by magnetic resonance		4 days	No
Secondary	infarct size measured by magnetic resonance		4 days	No
Secondary	oxidative stress		72 hours	No