Clinical trial NCT01218178: Sodium Bicarbonate and N-Acetylcysteine for Nephroprotection in Acute Myocardial Infarction
Official title: BIcarbonato di Sodio e N-Acetilcisteina Nella Prevenzione Della Nefropatia da Mezzo di Contrasto Nell'infaRto mIocardico acutO(Registro BINARIO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Acute Kidney Injury
Keywords: acute myocardial infarction
acute kidney injury
contrast induced nephropathy
primary PCI
sodium-bicarbonate
N-acetylcysteine
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: Policlinico Casilino ASL RMB
First posted: 2010-10-11
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
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

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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
* Chronic hemodialysis
* Age \>= 90 years

Primary outcomes:
measure: All cause mortality, contrast-induced nephropathy and need of dialysis.
timeFrame: 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Agostino Gemelli and Policlinico Casilino
Study officials:
affiliation: Catholic University of the Sacred Heart, Rome
name: Antonio Maria Leone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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