Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction

Phase 4

Completed

• Conditions: Acute Kidney Injury
• Interventions: Drug: Hydration plus N-acetylcisteine; Drug: Aminophylline

• Registration Number: NCT01594489
• Lead Sponsor: Ospedale Misericordia e Dolce

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2012-05-06
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-26
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Hydration plus N-acetylcisteine	Control group treated with hydration (sodium bicarbonate) and N-acetilcysteine
Aminophylline	Aminophylline	Additional Aminophylline therapy to hydration (sodium bicarbonate) and N-acetilcysteine

Primary Outcome Measures

Name	Time	Method
Incidence of Contrast-Induced Acute Kidney Injury	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ospedale Misericordia e Dolce; 🇮🇹 Prato, Italy