Efficacy of Statins In Prevention of CIN (SCIN)

University of Oklahoma (OU)

Status: Terminated

Conditions: Nephropathy

Treatments: Drug: placebo; Drug: atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01071993

15097

Details and patient eligibility

About

To determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.

Full description

Due to the conflict in the available data, there are no practice guidelines that are established in order to prevent contrast-induced nephropathy (CIN). Our goal is to determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.

Enrollment: 21 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion Criteria:

   • Adults > 18 years of age
   • undergoing coronary or peripheral angiography with or without intervention
   • Cr > 1.3 mg/dL or GFR < 60 mL/min

2. Exclusion Criteria:

   • end-stage renal disease on dialysis
   • acute renal failure
   • previous iodinated contrast media exposure within 7 days of study entry
   • history of hypersensitivity to statins
   • pregnancy or lactation
   • emergent coronary angiography, ST elevation myocardial infarction (STEMI), or cardiogenic shock
   • prisoners
   • patients already on maximum dose of statins
   • patient receiving N-acetylcysteine or sodium bicarbonate

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

atorvastatin

Active Comparator group

Treatment:

Drug: atorvastatin

placebo

Placebo Comparator group

Treatment:

Drug: placebo