Acute Myocardial InfarctionBINARIONCT01218178
Sodium Bicarbonate and N-Acetylcysteine for Nephroprotection in Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction and Acute Kidney Injury, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Contrast-induced nephropathy (CIN) represents a potential complication of diagnostic and therapeutic procedures in interventional cardiology, especially in the acute setting of primary PCI. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Acute Myocardial Infarction, Acute Kidney Injury
- What is being tested?
- Sodium bicarbonate plus NAC and Saline hydration plus NAC
- Type of treatment
- Injection or infusion
- How many people
- 520 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2008to Oct 2011
- Phase
- Observational
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: • Consecutive patients admitted from ER of the Policlinico Agostino Gemelli and Casilino of Rome with a ST-Segment Elevation Myocardial Infarction undergoing urgent PCI
Who may be able to join
- ST-Segment Elevation Myocardial Infarction (STEMI) as diagnosed according to the ACC (American College of Cardiology) criteria:
- ischemic symptoms;
- ECG variations: ST-elevation (>0,05 mV) in two or more contiguous leads;
- Increase of the biochemical markers of myocardial necrosis (troponin T, cTNT). • Indication to urgent coronary angiography and primary or rescue PCI
Who cannot join
- Patients with history of allergic reaction to NAC
- Chronic hemodialysis
- Age >= 90 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BIcarbonato di Sodio e N-Acetilcisteina Nella Prevenzione Della Nefropatia da Mezzo di Contrasto Nell'infaRto mIocardico acutO(Registro BINARIO)
Contrast-induced nephropathy (CIN) represents a potential complication of diagnostic and therapeutic procedures in interventional cardiology, especially in the acute setting of primary PCI. The investigators will test the efficacy of sodium bicarbonate (NaHCO3) and N-acetylcysteine (NAC) on the prevention of acute events and CIN in patients with acute myocardial infarction.
Read the detailed description
Introduction Contrast-induced nephropathy (CIN) represents a potential complication of diagnostic and therapeutic procedures in interventional cardiology. In the setting of elective procedures, the strategy of sodium bicarbonate (NaHCO3) and N-acetylcysteine (NAC) infusion has been shown to reduce the incidence of CIN in high-risk patients. The efficacy of this strategy has not been demonstrated in the case of primary percutaneous coronary intervention (PCI).
Aim of the study The aim is to assess the efficacy of the strategy of sodium bicarbonate 154mEq/l + glucose solution 5% (infusion rate: 3 mL • kg-1 • h-1 for 1 hour followed by 1 mL • kg-1 • h-1 for 6 hours) and NAC (1200 mg i.v. followed by 1200 mg bid for the next 48 hours) in reducing the incidence of CIN in patients with STEMI undergoing primary or rescue PCI. As control group, a population of STEMI patients treated with NAC (1200 mg i.v. followed by 1200 mg bid for the next 48 hours) + conventional hydration with saline solution 0.9% will be retrospectively enrolled. According to the common definition, CIN will be defined as increase of the level of serum creatinine >0,5 mg/dL and/or increase ≥25% serum creatinine and/or decrease ≥25% of the glomerular filtration rate (GFR) as calculated with the MDRD Modification of Diet in Renal Disease)formula at 48 hours after PCI compared with baseline value after primary PCI.
Study Design This is a two-center (Policlinico Gemelli and Policlinico Casilino, Rome, Italy), prospective, spontaneous (not sponsored) observational study.
Patient population
Inclusion criteria:
- Consecutive patients with ST-Segment Elevation Myocardial Infarction (STEMI) as diagnosed according to the ACC (American College of Cardiology) criteria:
- ischemic symptoms;
- ECG variations: ST-elevation (>0,05 mV) in two or more contiguous leads;
- Increase of the biochemical markers of myocardial necrosis (troponin T, cTNT).
- Indication to urgent coronary angiography and primary or rescue PCI
Exclusion criteria:
- Patients with history of allergic reaction to NAC (Fluimucil, Zambon Group Spa, Milan, Italy)
- Chronic hemodialysis
- Age > 90 years
Study protocol Patients will be treated with 154 mEq/L of sodium bicarbonate and glucose 5% solution (infusion rate of 3 mL • kg-1 • h-1 for 1 hour followed by 1 mL • kg-1 • h-1 for 6 hours) plus NAC (1200 mg i.v. followed by 1200 mg bid for the next 48 hours). As control group, a population of STEMI patients treated with conventional hydration with saline solution 0,9% and NAC (1200 mg i.v. followed by 1200 mg bid for the next 48 hours) according to the common clinical practice of the Department of Cardiovascular Medicine of the Policlinico Agostino Gemelli and of Cardiology Department of the Policlinico Casilino will be retrospectively enrolled.
Endpoints:
Primary endpoint:
- Composite endpoint (death/need for dialysis/CIN)
Secondary endpoints:
- assessment of individual major adverse events (death, re-infarction, need for dialysis) during at 1, 6 and 12 months
- assessment of the incidence of CIN defined as increase of the level of serum creatinine >0,5 mg/dL and/or increase ≥25% serum creatinine and/or decrease ≥25% of the glomerular filtration rate (GFR) as calculated with the MDRD formula at 48 hours after PCI compared with baseline value.
- Conditions
- Acute Myocardial Infarction, Acute Kidney Injury
- Being tested
- Sodium bicarbonate plus NAC, Saline hydration plus NAC
- Keywords
- acute myocardial infarction, acute kidney injury, contrast induced nephropathy, primary PCI, sodium-bicarbonate, N-acetylcysteine
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonate plus NACDrug
154 mEq/L sodium bicarbonate (infusion rate of 3 ml/Kg for 1 hour followed by 1 ml/Kg for 6 hours) plus NAC (1200 mg bid for 48 hours)
Saline hydration plus NACDrug
0.9% saline (1 ml/Kg for 12 hours) plus NAC (1200 mg bid for 48 hours)
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate plus NAC | Sodium bicarbonate plus NAC Receives: Drug: Sodium bicarbonate plus NAC | |
| Saline hydration plus NAC | Saline hydration plus NAC Receives: Drug: Saline hydration plus NAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality, contrast-induced nephropathy and need of dialysis.
To test the efficacy of sodium bicarbonate plus N-acetylcysteine vs saline hydration plus N-acetylcysteine to reduce mortality and to prevent contrast-induced nephropathy in the setting of primary PCI.
Measured: 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startJun 2008
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Observational
- Observational model
- Case-control
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Policlinico Casilino ASL RMB
- Responsible party
- Principal investigator, Antonio Maria Leone, Catholic University of the Sacred Heart
- Investigators
- Antonio Maria Leone, MD, PhD, Principal investigator, Catholic University of the Sacred Heart, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218178
- Sponsor's protocol ID
- P/479/CE/2010
- Acronym
- BINARIO
- Status last verified
- Mar 2015
- First submitted
- 4 Oct 2010
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.
PubMed 10075613Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328.
PubMed 15150204Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004 Oct 6;44(7):1393-9. doi: 10.1016/j.jacc.2004.06.068.
PubMed 15464318Wright RS, Reeder GS, Herzog CA, Albright RC, Williams BA, Dvorak DL, Miller WL, Murphy JG, Kopecky SL, Jaffe AS. Acute myocardial infarction and renal dysfunction: a high-risk combination. Ann Intern Med. 2002 Oct 1;137(7):563-70. doi: 10.7326/0003-4819-137-7-200210010-00007.
PubMed 12353943Marenzi G, Lauri G, Assanelli E, Campodonico J, De Metrio M, Marana I, Grazi M, Veglia F, Bartorelli AL. Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction. J Am Coll Cardiol. 2004 Nov 2;44(9):1780-5. doi: 10.1016/j.jacc.2004.07.043.
PubMed 15519007Adolph E, Holdt-Lehmann B, Chatterjee T, Paschka S, Prott A, Schneider H, Koerber T, Ince H, Steiner M, Schuff-Werner P, Nienaber CA. Renal Insufficiency Following Radiocontrast Exposure Trial (REINFORCE): a randomized comparison of sodium bicarbonate versus sodium chloride hydration for the prevention of contrast-induced nephropathy. Coron Artery Dis. 2008 Sep;19(6):413-9. doi: 10.1097/MCA.0b013e3283021ac6.
PubMed 18955835Marenzi G, Assanelli E, Marana I, Lauri G, Campodonico J, Grazi M, De Metrio M, Galli S, Fabbiocchi F, Montorsi P, Veglia F, Bartorelli AL. N-acetylcysteine and contrast-induced nephropathy in primary angioplasty. N Engl J Med. 2006 Jun 29;354(26):2773-82. doi: 10.1056/NEJMoa054209.
PubMed 16807414Tepel M, van der Giet M, Schwarzfeld C, Laufer U, Liermann D, Zidek W. Prevention of radiographic-contrast-agent-induced reductions in renal function by acetylcysteine. N Engl J Med. 2000 Jul 20;343(3):180-4. doi: 10.1056/NEJM200007203430304.
PubMed 10900277Chandel NS, McClintock DS, Feliciano CE, Wood TM, Melendez JA, Rodriguez AM, Schumacker PT. Reactive oxygen species generated at mitochondrial complex III stabilize hypoxia-inducible factor-1alpha during hypoxia: a mechanism of O2 sensing. J Biol Chem. 2000 Aug 18;275(33):25130-8. doi: 10.1074/jbc.M001914200.
PubMed 10833514DiMari J, Megyesi J, Udvarhelyi N, Price P, Davis R, Safirstein R. N-acetyl cysteine ameliorates ischemic renal failure. Am J Physiol. 1997 Mar;272(3 Pt 2):F292-8. doi: 10.1152/ajprenal.1997.272.3.F292.
PubMed 9087670Briguori C, Airoldi F, D'Andrea D, Bonizzoni E, Morici N, Focaccio A, Michev I, Montorfano M, Carlino M, Cosgrave J, Ricciardelli B, Colombo A. Renal Insufficiency Following Contrast Media Administration Trial (REMEDIAL): a randomized comparison of 3 preventive strategies. Circulation. 2007 Mar 13;115(10):1211-7. doi: 10.1161/CIRCULATIONAHA.106.687152. Epub 2007 Feb 19.
PubMed 17309916Solomon R, Deray G; Consensus Panel for CIN. How to prevent contrast-induced nephropathy and manage risk patients: practical recommendations. Kidney Int Suppl. 2006 Apr;(100):S51-3. doi: 10.1038/sj.ki.5000375. No abstract available.
PubMed 16612402McCullough PA, Wolyn R, Rocher LL, Levin RN, O'Neill WW. Acute renal failure after coronary intervention: incidence, risk factors, and relationship to mortality. Am J Med. 1997 Nov;103(5):368-75. doi: 10.1016/s0002-9343(97)00150-2.
PubMed 9375704Navaneethan SD, Singh S, Appasamy S, Wing RE, Sehgal AR. Sodium bicarbonate therapy for prevention of contrast-induced nephropathy: a systematic review and meta-analysis. Am J Kidney Dis. 2009 Apr;53(4):617-27. doi: 10.1053/j.ajkd.2008.08.033. Epub 2008 Nov 22.
PubMed 19027212Solomon R. The role of osmolality in the incidence of contrast-induced nephropathy: a systematic review of angiographic contrast media in high risk patients. Kidney Int. 2005 Nov;68(5):2256-63. doi: 10.1111/j.1523-1755.2005.00684.x.
PubMed 16221227
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIcarbonato di Sodio e N-Acetilcisteina Nella Prevenzione Della Nefropatia da Mezzo di Contrasto Nell'infaRto mIocardico acutO(Registro BINARIO)
- ClinicalTrials.gov ID
- NCT01218178
- Acronym / sponsor ID
- BINARIO / P/479/CE/2010
- Conditions
- Acute Myocardial Infarction, Acute Kidney Injury
- Keywords
- acute myocardial infarction, acute kidney injury, contrast induced nephropathy, primary PCI, sodium-bicarbonate, N-acetylcysteine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Policlinico Casilino ASL RMB
- Study start
- Jun 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 Oct 2010 (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.
Contrast-induced nephropathy (CIN) represents a potential complication of diagnostic and therapeutic procedures in interventional cardiology, especially in the acute setting of primary PCI. The investigators will test the efficacy of sodium bicarbonate (NaHCO3) and N-acetylcysteine (NAC) on the prevention of acute events and CIN in patients with acute myocardial infarction.
Detailed description
Introduction Contrast-induced nephropathy (CIN) represents a potential complication of diagnostic and therapeutic procedures in interventional cardiology. In the setting of elective procedures, the strategy of sodium bicarbonate (NaHCO3) and N-acetylcysteine (NAC) infusion has been shown to reduce the incidence of CIN in high-risk patients. The efficacy of this strategy has not been demonstrated in the case of primary percutaneous coronary intervention (PCI).
Aim of the study The aim is to assess the efficacy of the strategy of sodium bicarbonate 154mEq/l + glucose solution 5% (infusion rate: 3 mL • kg-1 • h-1 for 1 hour followed by 1 mL • kg-1 • h-1 for 6 hours) and NAC (1200 mg i.v. followed by 1200 mg bid for the next 48 hours) in reducing the incidence of CIN in patients with STEMI undergoing primary or rescue PCI. As control group, a population of STEMI patients treated with NAC (1200 mg i.v. followed by 1200 mg bid for the next 48 hours) + conventional hydration with saline solution 0.9% will be retrospectively enrolled. According to the common definition, CIN will be defined as increase of the level of serum creatinine >0,5 mg/dL and/or increase ≥25% serum creatinine and/or decrease ≥25% of the glomerular filtration rate (GFR) as calculated with the MDRD Modification of Diet in Renal Disease)formula at 48 hours after PCI compared with baseline value after primary PCI.
Study Design This is a two-center (Policlinico Gemelli and Policlinico Casilino, Rome, Italy), prospective, spontaneous (not sponsored) observational study.
Patient population
Inclusion criteria:
- Consecutive patients with ST-Segment Elevation Myocardial Infarction (STEMI) as diagnosed according to the ACC (American College of Cardiology) criteria:
- ischemic symptoms;
- ECG variations: ST-elevation (>0,05 mV) in two or more contiguous leads;
- Increase of the biochemical markers of myocardial necrosis (troponin T, cTNT).
- Indication to urgent coronary angiography and primary or rescue PCI
Exclusion criteria:
- Patients with history of allergic reaction to NAC (Fluimucil, Zambon Group Spa, Milan, Italy)
- Chronic hemodialysis
- Age > 90 years
Study protocol Patients will be treated with 154 mEq/L of sodium bicarbonate and glucose 5% solution (infusion rate of 3 mL • kg-1 • h-1 for 1 hour followed by 1 mL • kg-1 • h-1 for 6 hours) plus NAC (1200 mg i.v. followed by 1200 mg bid for the next 48 hours). As control group, a population of STEMI patients treated with conventional hydration with saline solution 0,9% and NAC (1200 mg i.v. followed by 1200 mg bid for the next 48 hours) according to the common clinical practice of the Department of Cardiovascular Medicine of the Policlinico Agostino Gemelli and of Cardiology Department of the Policlinico Casilino will be retrospectively enrolled.
Endpoints:
Primary endpoint:
- Composite endpoint (death/need for dialysis/CIN)
Secondary endpoints:
- assessment of individual major adverse events (death, re-infarction, need for dialysis) during at 1, 6 and 12 months
- assessment of the incidence of CIN defined as increase of the level of serum creatinine >0,5 mg/dL and/or increase ≥25% serum creatinine and/or decrease ≥25% of the glomerular filtration rate (GFR) as calculated with the MDRD formula at 48 hours after PCI compared with baseline value.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate plus NAC | – | Drug: Sodium bicarbonate plus NACSodium bicarbonate plus NAC |
| Saline hydration plus NAC | – | Drug: Saline hydration plus NACSaline hydration plus NAC |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- • Consecutive patients admitted from ER of the Policlinico Agostino Gemelli and Casilino of Rome with a ST-Segment Elevation Myocardial Infarction undergoing urgent PCI
Key inclusion criteria (4 listed)
- ST-Segment Elevation Myocardial Infarction (STEMI) as diagnosed according to the ACC (American College of Cardiology) criteria:
- ischemic symptoms;
- ECG variations: ST-elevation (>0,05 mV) in two or more contiguous leads;
- Increase of the biochemical markers of myocardial necrosis (troponin T, cTNT). • Indication to urgent coronary angiography and primary or rescue PCI
Key exclusion criteria (3 listed)
- Patients with history of allergic reaction to NAC
- Chronic hemodialysis
- Age >= 90 years
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 |
|---|---|---|
| Sodium bicarbonate plus NAC154 mEq/L sodium bicarbonate (infusion rate of 3 ml/Kg for 1 hour followed by 1 ml/Kg for 6 hours) plus NAC (1200 mg bid for 48 hours) | Drug | Sodium bicarbonate plus NAC |
| Saline hydration plus NAC0.9% saline (1 ml/Kg for 12 hours) plus NAC (1200 mg bid for 48 hours) | Drug | Saline hydration plus NAC |
Primary outcome
All cause mortality, contrast-induced nephropathy and need of dialysis.
Time frame: 2010
To test the efficacy of sodium bicarbonate plus N-acetylcysteine vs saline hydration plus N-acetylcysteine to reduce mortality and to prevent contrast-induced nephropathy in the setting of primary PCI.
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 13 Mar 2015.
- Background: PubMed 10075613Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.
- Background: PubMed 15150204Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328.
- Background: PubMed 15464318Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004 Oct 6;44(7):1393-9. doi: 10.1016/j.jacc.2004.06.068.
- Background: PubMed 12353943Wright RS, Reeder GS, Herzog CA, Albright RC, Williams BA, Dvorak DL, Miller WL, Murphy JG, Kopecky SL, Jaffe AS. Acute myocardial infarction and renal dysfunction: a high-risk combination. Ann Intern Med. 2002 Oct 1;137(7):563-70. doi: 10.7326/0003-4819-137-7-200210010-00007.
- Background: PubMed 15519007Marenzi G, Lauri G, Assanelli E, Campodonico J, De Metrio M, Marana I, Grazi M, Veglia F, Bartorelli AL. Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction. J Am Coll Cardiol. 2004 Nov 2;44(9):1780-5. doi: 10.1016/j.jacc.2004.07.043.
- Background: PubMed 18955835Adolph E, Holdt-Lehmann B, Chatterjee T, Paschka S, Prott A, Schneider H, Koerber T, Ince H, Steiner M, Schuff-Werner P, Nienaber CA. Renal Insufficiency Following Radiocontrast Exposure Trial (REINFORCE): a randomized comparison of sodium bicarbonate versus sodium chloride hydration for the prevention of contrast-induced nephropathy. Coron Artery Dis. 2008 Sep;19(6):413-9. doi: 10.1097/MCA.0b013e3283021ac6.
- Background: PubMed 16807414Marenzi G, Assanelli E, Marana I, Lauri G, Campodonico J, Grazi M, De Metrio M, Galli S, Fabbiocchi F, Montorsi P, Veglia F, Bartorelli AL. N-acetylcysteine and contrast-induced nephropathy in primary angioplasty. N Engl J Med. 2006 Jun 29;354(26):2773-82. doi: 10.1056/NEJMoa054209.
- Background: PubMed 10900277Tepel M, van der Giet M, Schwarzfeld C, Laufer U, Liermann D, Zidek W. Prevention of radiographic-contrast-agent-induced reductions in renal function by acetylcysteine. N Engl J Med. 2000 Jul 20;343(3):180-4. doi: 10.1056/NEJM200007203430304.
- Background: PubMed 10833514Chandel NS, McClintock DS, Feliciano CE, Wood TM, Melendez JA, Rodriguez AM, Schumacker PT. Reactive oxygen species generated at mitochondrial complex III stabilize hypoxia-inducible factor-1alpha during hypoxia: a mechanism of O2 sensing. J Biol Chem. 2000 Aug 18;275(33):25130-8. doi: 10.1074/jbc.M001914200.
- Background: PubMed 9087670DiMari J, Megyesi J, Udvarhelyi N, Price P, Davis R, Safirstein R. N-acetyl cysteine ameliorates ischemic renal failure. Am J Physiol. 1997 Mar;272(3 Pt 2):F292-8. doi: 10.1152/ajprenal.1997.272.3.F292.
- Background: PubMed 17309916Briguori C, Airoldi F, D'Andrea D, Bonizzoni E, Morici N, Focaccio A, Michev I, Montorfano M, Carlino M, Cosgrave J, Ricciardelli B, Colombo A. Renal Insufficiency Following Contrast Media Administration Trial (REMEDIAL): a randomized comparison of 3 preventive strategies. Circulation. 2007 Mar 13;115(10):1211-7. doi: 10.1161/CIRCULATIONAHA.106.687152. Epub 2007 Feb 19.
- Background: PubMed 16612402Solomon R, Deray G; Consensus Panel for CIN. How to prevent contrast-induced nephropathy and manage risk patients: practical recommendations. Kidney Int Suppl. 2006 Apr;(100):S51-3. doi: 10.1038/sj.ki.5000375. No abstract available.
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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.
Antonio Maria Leone, MD, PhD principal investigator
Catholic University of the Sacred Heart, Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Acute Kidney Injury, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 4 inclusion and 3 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 13 Mar 2015. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
All cause mortality, contrast-induced nephropathy and need of dialysis. (time frame: 2010). 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 NCT01218178, which also lists 17 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 13 Mar 2015.