Trial | NCT01594489  Report issue

Title

Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction
Effect of Aminophylline on Contrast Induced Acute Kidney Injury in Patients With Acute Myocardial Infarction Treated With Primary Angioplasty

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    250
The purpose of this study is to determine whether additional therapy with Aminophylline to hydration with sodium bicarbonate and administration of N-acetylcysteine is more effective to prevent contrast induced acute kidney injury in patients undergoing primary coronary intervention for acute ST elevation myocardial infarction.
Due to the clinical relevance of contrast acute kidney injury a large number of prophylactic procedures have been investigated. N-acetylcysteine and hydration with sodium bicarbonate are proved to be protective against contrast acute kidney injury. The adenosine-mediated afferent arteriolar vasoconstriction is a possible pathomechanism of renal impairment by contrast agent. It has been observed that aminophylline/theophylline, competitive adenosine antagonists, improves oxygen delivery to ischemic tissue, diminishes oxidative damage to renal tissue and may also scavenge free radicals.

The purpose of this study was to investigated whether the additional therapy with adenosine antagonist aminophylline reduces the incidence of contrast renal damage in high risk patients who have acute myocardial infarction.
Study Started
Jan 31
2009
Primary Completion
Sep 30
2012
Study Completion
Sep 30
2012
Last Update
Oct 30
2012
Estimate

Drug Aminophylline

200 mg of aminophylline administrated intravenously as a short infusion, started in emergency department, before primary angioplasty and contrast medium administration Sodium bicarbonate (154 mEq/L in dextrose and H20) 3mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after procedure N-acetilcysteine: intravenous bolus of 1200 mg before angioplasty and 1200 mg twice daily for the 48 hours after PCI

Drug Hydration plus N-acetylcisteine

Sodium bicarbonate (154 mEq/L in dextrose and H20) 3mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after procedure N-acetilcysteine: intravenous bolus of 1200 mg before angioplasty and 1200 mg twice daily for the 48 hours after PCI

Aminophylline Experimental

Additional Aminophylline therapy to hydration (sodium bicarbonate) and N-acetilcysteine

Control group Active Comparator

Control group treated with hydration (sodium bicarbonate) and N-acetilcysteine

Criteria 

Inclusion Criteria:

Consecutive patients with AMI candidates for primary PCI presenting within 12 h of symptom onset with ST-segment elevation of more than 1 mm in at least two contiguous leads of the electrocardiogram

Exclusion Criteria:

contrast medium administration within the previous 10 days,
end-stage renal failure requiring dialysis,
refusal to give informed consent
No Results Posted