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临床试验/NCT00317252
NCT00317252已完成2 期

Angiotensin Converting Enzyme Inhibitors and Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization "The CAPTAIN Trial"

Hamilton Health Sciences Corporation1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
220
试验地点
1
主要终点
Contrast induced nephropathy (creatinine rise of 44umol/L or 25% compared to the pre-randomization creatinine level) at 48-96hrs

研究概览

简要总结

The purpose of this study is to determine if patients should stop taking their angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) around the time of their angiogram in order to prevent contrast induced nephropathy (CIN).

详细描述

There are approximately 4000 coronary angiograms performed annually at the Hamilton General Hospital to diagnose and treat coronary artery disease. Many of the patients undergoing this procedure have mild kidney disease. Exposure to the contrast dye used in the procedure puts them at risk of worsening kidney function, a condition called contrast induced nephropathy (CIN) which is associated with significant morbidity and mortality. Many of these patients are also on an antihypertensive drug called an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). Their effects on the kidney during contrast exposure are not known. Our understanding of how the drug works leads us to believe that the use of these drugs around the time of contrast exposure may have detrimental effects on the kidney.

The purpose of this study is to determine if patients should continue taking or stop taking their ACE inhibitor or ARB around the time of their angiogram in order to prevent CIN.

Patients undergoing an elective coronary angiogram with mild kidney disease and currently taking an ACE inhibitor or ARB will be randomly divided into two groups. One group will continue taking their ACE inhibitor or ARB while the other group will stop taking their ACE inhibitor or ARB for at least 24 hours before and will resume their ACE inhibitor or ARB 48 to 96 hours after their angiogram. In both groups, kidney function will be assessed by means of a simple blood test both before and 48 to 96 hours after the angiogram. By doing this, we can determine which group had more kidney damage and which group had less kidney damage from the contrast exposure. We suspect that patients who do not take their ACE inhibitor around the time of their angiogram will have less kidney damage. All patients will receive the accepted measures for preventing kidney disease from contrast dye exposure.

CIN is associated with significant morbidity and mortality. If the use of ACEIs during coronary angiograms are associated with an increased risk of CIN, then these patients may benefit from holding their ACEI around the time of their procedure potentially improving their outcomes. This is a low cost intervention that could potentially change practice, reduce morbidity, save lives and pave the way for larger clinical trials.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Scheduled for Angiography in >= 24hrs from enrolment
  • Documented Cr >= 150 within 3 months before cardiac catheterization AND/OR documented Cr >= 132umol/L within 1 week Before Cardiac Catheterization
  • Currently Taking an ACE Inhibitor

排除标准

  • Patients with end stage renal disease (for example, patient on dialysis)
  • Emergency Cardiac Catheterization with insufficient time to hold the ACEI
  • Acute Pulmonary Edema

研究组 & 干预措施

Hold ACEI or ARB

Experimental

Angiotensin converting enzyme inhibitor or angiotensin receptor blocker held >= 24 hours pre-cardiac catheterization and restarted post-catheterization after creatinine measurement (48-96 hours post)

干预措施: Hold ACEI or ARB (Drug)

Continue ACE1 or ARB

Other

Randomized to continue on prescribed ACE1 or ARB

干预措施: Hold ACEI or ARB (Drug)

结局指标

主要结局

Contrast induced nephropathy (creatinine rise of 44umol/L or 25% compared to the pre-randomization creatinine level) at 48-96hrs

时间窗: 48 - 96 hours post-cardiac catheterization

次要结局

  • Change in serum creatinine at 48-96hrs(48 - 96 hours post-cardiac catheterization)
  • Change in creatinine clearance at 48-96hrs(48 - 96 hours post-cardiac catheterization)
  • Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-96hrs.(48 - 96 hours post-cardiac catheterization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Shamir Mehta

Associate Professor of Medicine

McMaster University

研究点 (1)

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