Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction

• ClinicalTrials.gov Identifier: NCT01594489
• Recruitment Status: Completed
• First Posted: May 9, 2012
• Last Update Posted: October 30, 2012
• Sponsor: Ospedale Misericordia e Dolce
• Information provided by (Responsible Party): Mauro Maioli, Ospedale Misericordia e Dolce

Tracking Information

• First Submitted Date: May 6, 2012
• First Posted Date: May 9, 2012
• Last Update Posted Date: October 30, 2012
• Study Start Date: January 2009
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 8, 2012)

Incidence of Contrast-Induced Acute Kidney Injury [ Time Frame: 3 days ]

Contrast-Induced Acute Kidney Injury is defined as an increase in serum creatinine of >=25% or 0.5 mg/dL over the baseline value within 3 days after the administration of the contrast medium

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 8, 2012)

Adverse clinical events [ Time Frame: 1 month ]

Adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction
• Official Title: Effect of Aminophylline on Contrast Induced Acute Kidney Injury in Patients With Acute Myocardial Infarction Treated With Primary Angioplasty
• Brief Summary: 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.

Detailed Description

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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Acute Kidney Injury

Intervention

• 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

Study Arms

• Experimental: Aminophylline
  Additional Aminophylline therapy to hydration (sodium bicarbonate) and N-acetilcysteine
  Intervention: Drug: Aminophylline
• Active Comparator: Control group
  Control group treated with hydration (sodium bicarbonate) and N-acetilcysteine
  Intervention: Drug: Hydration plus N-acetylcisteine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 8, 2012): 250
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2012
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT01594489
• Other Study ID Numbers: Prato0704
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Mauro Maioli, Ospedale Misericordia e Dolce
• Study Sponsor: Ospedale Misericordia e Dolce
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mauro Maioli, MD; Cardiology Unit, Misericordia e Dolce Hospital, Prato, Italy

• PRS Account: Ospedale Misericordia e Dolce
• Verification Date: October 2012