Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study)

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Renal hypoxia plays an important role in the development of contrast-induced nephropathy. The purpose of the PRINCIPLE study is to investigate the effect of pretreatment with intravenous nicorandil on the incidence of contrast-induced nephropathy in patients with renal insufficiency undergoing coronary angiography.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Collaborator: GE Healthcare
• Treatments: Nicorandil

Criteria

Inclusion Criteria:

• Patients aged ≥ 20 years

• Patients undergoing elective coronary angiogram due to documented myocardial ischemia or symptoms of angina

• Estimated Cr clearance ≤60 mL/min by Cockcroft-Gault formula or serum Cr ≥1.1 mg/dL

• Signed written informed consent to participate in the study

Exclusion Criteria:

• Acute myocardial infarction requiring primary or rescue coronary intervention

• Allergic reaction to contrast dye or nicorandil

• Cardiogenic shock or significant hypotension

• Previous use of nicorandil within the preceding 7 days

• Exposure to contrast medium within the preceding 7 days

• Pregnancy or women at age of childbearing potential

• Heart failure (NYHA class III or IV; LV ejection fraction <40% by echocardiogram)

• Acute renal failure or chronic dialysis

• Mechanical ventilation

• History of kidney transplantation

• Life expectation less than 6 months

• Previous renal artery angioplasty within the last 6 months

• Use of nonsteroidal anti-inflammatory drugs, intravenous use of diuretics, dopamine, mannitol, N-acetylcysteine, ascorbic acid or sodium bicarbonate within 48 hrs before the procedure

• Severe liver disease