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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aminophylline | Experimental | Additional Aminophylline therapy to hydration (sodium bicarbonate) and N-acetilcysteine |
|
| Control group | Active Comparator | Control group treated with hydration (sodium bicarbonate) and N-acetilcysteine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminophylline | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse clinical events | Adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauro Maioli, MD | Cardiology Unit, Misericordia e Dolce Hospital, Prato, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Misericordia e Dolce | Prato | Prato | 59100 | Italy |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000628 | Aminophylline |
| ID | Term |
|---|---|
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 |
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|
| Hydration plus N-acetylcisteine | Drug |
|
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Organic Chemicals |
| D013806 | Theophylline |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |