Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein (LIPSIA-N-ACC)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Acetylcystein
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring primary PCI, nephropathy, infarct size, infarction, ST-elevation myocardial infarction
Eligibility Criteria
Inclusion Criteria:
- ST-elevation infarction (<12 hours)
- Angina
Exclusion Criteria:
- Prior fibrinolysis
- Dialysis
- Pregnancy
- Lactase-reduction
- Glucose-galactose malabsorption
- Known allergy to acetylcystein
Sites / Locations
- University of Leipzig - Heart Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
High-dose N-Acetylcystein during percutaneous coronary intervention and for 2 days post intervention 2 x/day
Placebo (NaCl)
Outcomes
Primary Outcome Measures
Myocardial salvage measured by magnetic resonance imaging
prevention of nephropathy
Secondary Outcome Measures
ST-segment resolution
TIMI flow
composite clinical endpoint (death, reinfarction, congestive heart failure)
need for dialysis
microvascular obstruction measured by magnetic resonance
infarct size measured by magnetic resonance
oxidative stress
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00463749
Brief Title
Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Leipzig
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
primary PCI, nephropathy, infarct size, infarction, ST-elevation myocardial infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
251 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
High-dose N-Acetylcystein during percutaneous coronary intervention and for 2 days post intervention 2 x/day
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo (NaCl)
Intervention Type
Drug
Intervention Name(s)
Acetylcystein
Intervention Description
high-dose N-Acetylcystein during PCI and for 2/day for 2 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
NaCl as placebo
Primary Outcome Measure Information:
Title
Myocardial salvage measured by magnetic resonance imaging
Time Frame
4 days
Title
prevention of nephropathy
Time Frame
3 days
Secondary Outcome Measure Information:
Title
ST-segment resolution
Time Frame
90 min
Title
TIMI flow
Time Frame
minutes
Title
composite clinical endpoint (death, reinfarction, congestive heart failure)
Time Frame
30 days
Title
need for dialysis
Time Frame
4 days
Title
microvascular obstruction measured by magnetic resonance
Time Frame
4 days
Title
infarct size measured by magnetic resonance
Time Frame
4 days
Title
oxidative stress
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ST-elevation infarction (<12 hours)
Angina
Exclusion Criteria:
Prior fibrinolysis
Dialysis
Pregnancy
Lactase-reduction
Glucose-galactose malabsorption
Known allergy to acetylcystein
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Thiele, MD
Organizational Affiliation
Heart Center Leipzig - University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University of Leipzig - Heart Center
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24962156
Citation
de Waha S, Eitel I, Desch S, Fuernau G, Lurz P, Stiermaier T, Blazek S, Schuler G, Thiele H. Prognosis after ST-elevation myocardial infarction: a study on cardiac magnetic resonance imaging versus clinical routine. Trials. 2014 Jun 25;15:249. doi: 10.1186/1745-6215-15-249.
Results Reference
derived
PubMed Identifier
22704876
Citation
Fuernau G, Zaehringer S, Eitel I, de Waha S, Droppa M, Desch S, Schuler G, Adams V, Thiele H. Osteoprotegerin in ST-elevation myocardial infarction: prognostic impact and association with markers of myocardial damage by magnetic resonance imaging. Int J Cardiol. 2013 Sep 1;167(5):2134-9. doi: 10.1016/j.ijcard.2012.05.101. Epub 2012 Jun 15.
Results Reference
derived
PubMed Identifier
21920334
Citation
Fuernau G, Eitel I, Franke V, Hildebrandt L, Meissner J, de Waha S, Lurz P, Gutberlet M, Desch S, Schuler G, Thiele H. Myocardium at risk in ST-segment elevation myocardial infarction comparison of T2-weighted edema imaging with the MR-assessed endocardial surface area and validation against angiographic scoring. JACC Cardiovasc Imaging. 2011 Sep;4(9):967-76. doi: 10.1016/j.jcmg.2011.02.023.
Results Reference
derived
PubMed Identifier
21710343
Citation
Droppa M, Desch S, Blase P, Eitel I, Fuernau G, Schuler G, Adams V, Thiele H. Impact of N-acetylcysteine on contrast-induced nephropathy defined by cystatin C in patients with ST-elevation myocardial infarction undergoing primary angioplasty. Clin Res Cardiol. 2011 Nov;100(11):1037-43. doi: 10.1007/s00392-011-0338-8. Epub 2011 Jun 28.
Results Reference
derived
PubMed Identifier
21345844
Citation
Eitel I, Blase P, Adams V, Hildebrand L, Desch S, Schuler G, Thiele H. Growth-differentiation factor 15 as predictor of mortality in acute reperfused ST-elevation myocardial infarction: insights from cardiovascular magnetic resonance. Heart. 2011 Apr;97(8):632-40. doi: 10.1136/hrt.2010.219543. Epub 2011 Feb 22.
Results Reference
derived
PubMed Identifier
20466200
Citation
Thiele H, Hildebrand L, Schirdewahn C, Eitel I, Adams V, Fuernau G, Erbs S, Linke A, Diederich KW, Nowak M, Desch S, Gutberlet M, Schuler G. Impact of high-dose N-acetylcysteine versus placebo on contrast-induced nephropathy and myocardial reperfusion injury in unselected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. The LIPSIA-N-ACC (Prospective, Single-Blind, Placebo-Controlled, Randomized Leipzig Immediate PercutaneouS Coronary Intervention Acute Myocardial Infarction N-ACC) Trial. J Am Coll Cardiol. 2010 May 18;55(20):2201-9. doi: 10.1016/j.jacc.2009.08.091.
Results Reference
derived
PubMed Identifier
20435200
Citation
Eitel I, Nowak M, Stehl C, Adams V, Fuernau G, Hildebrand L, Desch S, Schuler G, Thiele H. Endothelin-1 release in acute myocardial infarction as a predictor of long-term prognosis and no-reflow assessed by contrast-enhanced magnetic resonance imaging. Am Heart J. 2010 May;159(5):882-90. doi: 10.1016/j.ahj.2010.02.019.
Results Reference
derived
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Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein
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