Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein (LIPSIA-N-ACC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00463749
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : July 8, 2008
Information provided by:
University of Leipzig

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Acetylcystein Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Trial to Compare Infarct Size and Occurrence of Contrast Dye Induced Nephropathy in Patients With Primary Percutaneous PCI in STEMI
Study Start Date : December 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: 1
High-dose N-Acetylcystein during percutaneous coronary intervention and for 2 days post intervention 2 x/day
Drug: Acetylcystein
high-dose N-Acetylcystein during PCI and for 2/day for 2 days

Placebo Comparator: 2
Placebo (NaCl)
Drug: Placebo
NaCl as placebo

Primary Outcome Measures :
  1. Myocardial salvage measured by magnetic resonance imaging [ Time Frame: 4 days ]
  2. prevention of nephropathy [ Time Frame: 3 days ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00463749

University of Leipzig - Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Study Chair: Holger Thiele, MD Heartcenter Leipzig GmbH

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Holger Thiele, MD, University of Leipzig - Heart Center Identifier: NCT00463749     History of Changes
Other Study ID Numbers: 1111/2006
First Posted: April 20, 2007    Key Record Dates
Last Update Posted: July 8, 2008
Last Verified: July 2008

Keywords provided by University of Leipzig:
primary PCI
infarct size
ST-elevation myocardial infarction

Additional relevant MeSH terms:
Myocardial Infarction
Kidney Diseases
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Urologic Diseases