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Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction

NCT ID: NCT01594489

Last Updated: 2012-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Aminophylline

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

Group Type EXPERIMENTAL

Aminophylline

Intervention Type DRUG

* 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

Control group

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

Group Type ACTIVE_COMPARATOR

Hydration plus N-acetylcisteine

Intervention Type DRUG

* 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Misericordia e Dolce

OTHER

Sponsor Role lead

Responsible Party

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Mauro Maioli

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mauro Maioli, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Unit, Misericordia e Dolce Hospital, Prato, Italy

Locations

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Ospedale Misericordia e Dolce

Prato, Prato, Italy

Site Status

Countries

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Italy

Other Identifiers

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Prato0704

Identifier Type: -

Identifier Source: org_study_id