Myocardial InfarctionPhase 3LIPSIA-N-ACCNCT00463749
Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein
A Phase 3 study testing Acetylcystein in people with Myocardial Infarction, run by University of Leipzig at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Acetylcystein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 251 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2006to Jun 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ST-elevation infarction (<12 hours)
- Angina
Who cannot join
- Prior fibrinolysis
- Dialysis
- Pregnancy
- Lactase-reduction
- Glucose-galactose malabsorption
- Known allergy to acetylcystein
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial to Compare Infarct Size and Occurrence of Contrast Dye Induced Nephropathy in Patients With Primary Percutaneous PCI in STEMI
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.
- Conditions
- Myocardial Infarction
- Being tested
- Acetylcystein, Placebo
- Keywords
- primary PCI, nephropathy, infarct size, infarction, ST-elevation myocardial infarction
- Medical subject headings
- Myocardial Infarction, Kidney Diseases, Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetylcysteinDrug
high-dose N-Acetylcystein during PCI and for 2/day for 2 days
PlaceboDrug
NaCl as placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | High-dose N-Acetylcystein during percutaneous coronary intervention and for 2 days post intervention 2 x/day Receives: Drug: Acetylcystein |
| 2 | Placebo comparator | Placebo (NaCl) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial salvage measured by magnetic resonance imaging
Measured: 4 days
prevention of nephropathy
Measured: 3 days
Secondary outcomes (7)
ST-segment resolution
Measured: 90 min
TIMI flow
Measured: minutes
composite clinical endpoint (death, reinfarction, congestive heart failure)
Measured: 30 days
need for dialysis
Measured: 4 days
microvascular obstruction measured by magnetic resonance
Measured: 4 days
infarct size measured by magnetic resonance
Measured: 4 days
oxidative stress
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startDec 2006
- Primary completionFeb 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Investigators
- Holger Thiele, MD, Study chair, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463749
- Sponsor's protocol ID
- 1111/2006
- Acronym
- LIPSIA-N-ACC
- Status last verified
- Jul 2008
- First submitted
- 18 Apr 2007
- Last updated
- 8 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24962156Fuernau 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.
PubMed 22704876Fuernau 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.
PubMed 21920334Droppa 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.
PubMed 21710343Eitel 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.
PubMed 21345844Thiele 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.
PubMed 20466200Eitel 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.
PubMed 20435200
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Compare Infarct Size and Occurrence of Contrast Dye Induced Nephropathy in Patients With Primary Percutaneous PCI in STEMI
- ClinicalTrials.gov ID
- NCT00463749
- Acronym / sponsor ID
- LIPSIA-N-ACC / 1111/2006
- Conditions
- Myocardial Infarction
- Keywords
- primary PCI, nephropathy, infarct size, infarction, ST-elevation myocardial infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 20 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AcetylcysteinHigh-dose N-Acetylcystein during percutaneous coronary intervention and for 2 days post intervention 2 x/day |
| 2 | Placebo comparator | Drug: PlaceboPlacebo (NaCl) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ST-elevation infarction (<12 hours)
- Angina
Key exclusion criteria (6 listed)
- Prior fibrinolysis
- Dialysis
- Pregnancy
- Lactase-reduction
- Glucose-galactose malabsorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylcysteinhigh-dose N-Acetylcystein during PCI and for 2/day for 2 days | Drug | 1 |
| PlaceboNaCl as placebo | Drug | 2 |
Primary outcome
Myocardial salvage measured by magnetic resonance imaging
Time frame: 4 days
prevention of nephropathy
Time frame: 3 days
7 secondary outcomes
ST-segment resolution
Time frame: 90 min
TIMI flow
Time frame: minutes
composite clinical endpoint (death, reinfarction, congestive heart failure)
Time frame: 30 days
need for dialysis
Time frame: 4 days
microvascular obstruction measured by magnetic resonance
Time frame: 4 days
infarct size measured by magnetic resonance
Time frame: 4 days
oxidative stress
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2008.
- Derived from this study: PubMed 24962156de 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.
- Derived from this study: PubMed 22704876Fuernau 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.
- Derived from this study: PubMed 21920334Fuernau 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.
- Derived from this study: PubMed 21710343Droppa 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.
- Derived from this study: PubMed 21345844Eitel 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.
- Derived from this study: PubMed 20466200Thiele 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.
- Derived from this study: PubMed 20435200Eitel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holger Thiele, MD study chair
Heart Center Leipzig - University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylcystein in people with Myocardial Infarction, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial salvage measured by magnetic resonance imaging (time frame: 4 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00463749, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2008.