Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction

NCT01594489 | Completed Phase 4 DMC

• 1 other identifier: Prato0704
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Incidence of Contrast-Induced Acute Kidney Injury

  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

  3 days

Secondary Outcomes (1)

• Adverse clinical events

  1 month

Study Arms (2)

Aminophylline

EXPERIMENTAL

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

Drug: Aminophylline

Control group

ACTIVE COMPARATOR

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

Drug: Hydration plus N-acetylcisteine

Interventions

Aminophylline 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

Aminophylline

Hydration plus N-acetylcisteine 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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• contrast medium administration within the previous 10 days,
• end-stage renal failure requiring dialysis,
• refusal to give informed consent

Sponsors & Collaborators

• Ospedale Misericordia e Dolce: lead

Study Sites (1)

Ospedale Misericordia e Dolce

Prato, Prato, 59100, Italy

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Aminophylline

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Mauro Maioli, MD

  Cardiology Unit, Misericordia e Dolce Hospital, Prato, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 6, 2012
• First Posted: May 9, 2012
• Study Start: January 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

IT (1)