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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00463749
Acronym
LIPSIA-N-ACC
Enrollment
251
Registered
2007-04-20
Start date
2006-12-31
Completion date
2008-06-30
Last updated
2008-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

primary PCI, nephropathy, infarct size, infarction, ST-elevation myocardial infarction

Brief 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.

Interventions

high-dose N-Acetylcystein during PCI and for 2/day for 2 days

DRUGPlacebo

NaCl as placebo

Sponsors

University of Leipzig
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ST-elevation infarction (\<12 hours) * Angina

Exclusion criteria

* Prior fibrinolysis * Dialysis * Pregnancy * Lactase-reduction * Glucose-galactose malabsorption * Known allergy to acetylcystein

Design outcomes

Primary

MeasureTime frame
Myocardial salvage measured by magnetic resonance imaging4 days
prevention of nephropathy3 days

Secondary

MeasureTime frame
composite clinical endpoint (death, reinfarction, congestive heart failure)30 days
need for dialysis4 days
ST-segment resolution90 min
infarct size measured by magnetic resonance4 days
oxidative stress72 hours
microvascular obstruction measured by magnetic resonance4 days
TIMI flowminutes

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026