Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction

Ospedale Misericordia e Dolce

Status and phase: Completed; Phase 4

Conditions: Acute Kidney Injury

Treatments: Drug: Hydration plus N-acetylcisteine; Drug: Aminophylline

Study type: Interventional

Funder types: Other

Identifiers

NCT01594489

Prato0704

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups

Aminophylline

Experimental group

Description:

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

Treatment:

Drug: Aminophylline

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Hydration plus N-acetylcisteine