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OpenTrials
Completed

NCT Number: NCT00463749

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Infarction Ischemia Kidney Diseases Male Urogenital Diseases Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Leipzig - Heart Center

Leipzig, 04289, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ST-elevation infarction (<12 hours)
  • Angina

Exclusion criteria

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

Treatment and study plan

Acetylcystein

Drug

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

Placebo

Drug

NaCl as placebo

Primary outcomes

  1. Myocardial salvage measured by magnetic resonance imaging

    Time frame: 4 days

  2. prevention of nephropathy

    Time frame: 3 days

Secondary outcomes

  1. ST-segment resolution

    Time frame: 90 min

  2. TIMI flow

    Time frame: minutes

  3. composite clinical endpoint (death, reinfarction, congestive heart failure)

    Time frame: 30 days

  4. need for dialysis

    Time frame: 4 days

  5. microvascular obstruction measured by magnetic resonance

    Time frame: 4 days

  6. infarct size measured by magnetic resonance

    Time frame: 4 days

  7. oxidative stress

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

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

Acronym: LIPSIA-N-ACC

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 20, 2007
Registry last updated
Jul 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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