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

This study has been completed.
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00463749
First received: April 18, 2007
Last updated: July 7, 2008
Last verified: July 2008
  Purpose

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 Intervention Phase
Myocardial Infarction
Drug: Acetylcystein
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Myocardial salvage measured by magnetic resonance imaging [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • prevention of nephropathy [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ST-segment resolution [ Time Frame: 90 min ] [ Designated as safety issue: No ]
  • TIMI flow [ Time Frame: minutes ] [ Designated as safety issue: No ]
  • composite clinical endpoint (death, reinfarction, congestive heart failure) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • need for dialysis [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • microvascular obstruction measured by magnetic resonance [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • infarct size measured by magnetic resonance [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • oxidative stress [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Enrollment: 251
Study Start Date: December 2006
Study Completion Date: June 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior fibrinolysis
  • Dialysis
  • Pregnancy
  • Lactase-reduction
  • Glucose-galactose malabsorption
  • Known allergy to acetylcystein
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463749

Locations
Germany
University of Leipzig - Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
Study Chair: Holger Thiele, MD University of Leipzig
  More Information

No publications provided by University of Leipzig

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Holger Thiele, MD, University of Leipzig - Heart Center
ClinicalTrials.gov Identifier: NCT00463749     History of Changes
Other Study ID Numbers: 1111/2006
Study First Received: April 18, 2007
Last Updated: July 7, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on September 14, 2014