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Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mauro Maioli, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier:
NCT01594489
First received: May 6, 2012
Last updated: October 26, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Kidney Injury
 Drug: Aminophylline
Drug: Hydration plus N-acetylcisteine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Aminophylline on Contrast Induced Acute Kidney Injury in Patients With Acute Myocardial Infarction Treated With Primary Angioplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ospedale Misericordia e Dolce:

Primary Outcome Measures:
  • Incidence of Contrast-Induced Acute Kidney Injury [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Adverse clinical events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration


Enrollment: 250
Study Start Date: January 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aminophylline
Additional Aminophylline therapy to hydration (sodium bicarbonate) and N-acetilcysteine
 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
Active Comparator: Control group
Control group treated with hydration (sodium bicarbonate) and N-acetilcysteine
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594489

Locations
Italy
Ospedale Misericordia e Dolce
Prato, Italy, 59100
Sponsors and Collaborators
Ospedale Misericordia e Dolce
Investigators
Principal Investigator: Mauro Maioli, MD Cardiology Unit, Misericordia e Dolce Hospital, Prato, Italy
  More Information

No publications provided

Responsible Party: Mauro Maioli, Medical Doctor, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier: NCT01594489     History of Changes
Other Study ID Numbers: Prato0704
Study First Received: May 6, 2012
Last Updated: October 26, 2012
Health Authority: Italy: National Bioethics Committee

Additional relevant MeSH terms:
Infarction
Acute Kidney Injury
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aminophylline
Cardiotonic Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents

ClinicalTrials.gov processed this record on May 23, 2013