跳至主要内容
临床试验/NCT00612521
NCT00612521终止3 期

Prophylactic Intra-coronary Adenosine to Prevent Post Coronary Artery Stenting Myonecrosis

Ottawa Heart Institute Research Corporation1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
入组人数
200
试验地点
1
主要终点
Peri-procedural myocardial infarction

研究概览

简要总结

Myocardial damage occurs in up to 40% of cases when sensitive biomarkers are measured after coronary artery stenting. Such events have been associated with poor outcomes both at 30 days and long term. The cause of such damage is multi-factorial and includes distal propagation of atheromatous and thrombotic debris and the subsequent infiltration of the microcirculation with inflammatory cells. Individually or together these events can occlude the micro-circulation and lead impaired blood flow to heart muscle.

The vasodilator adenosine is commonly used in cases of impaired flow in an endeavor to improve flow rate and limit myocardial damage. Unfortunately the efficacy of this therapy is limited. More recently, there have been clinical studies looking at the administration of adenosine before any potential damage by ballooning or stenting, in an effort to avoid poor distal flow post procedure and thus limit any myocardial damage. Although small numbers of subjects have been included in these trials, there have been encouraging preliminary data.

The aim of this study is to assess whether the use of intra-coronary adenosine given directly into the target coronary artery prior to stenting can reduce the incidence of myonecrosis (heart muscle damage)over placebo. We also aim to assess whether this translates to better outcomes at 30 day follow up.

详细描述

Prior clinical studies looking at the administration of adenosine before coronary artery stenting have looked at small numbers of subjects and did not mandate previous statin therapy or high dose loading of clopidogrel before stenting, both of which can also help lower the rate of peri-procedural myonecrosis.

Our aim is to assess the above mentioned therapy in patients on optimal treatment with statins, dual antiplatelet agents and standard of care anti-coagulants.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing percutaneous coronary balloon angioplasty and stenting
  • Ages 18 years and older
  • TIMI III flow on the initial angiography
  • Native coronary artery lesions

排除标准

  • Patients unable to give consent
  • Adenosine allergy
  • Severe asthma with bronchial reactivity
  • Cardiogenic or circulatory shock
  • Acute or chronic total coronary artery occlusions
  • Patients requiring Rotablator therapy
  • In stent restenosis
  • Second or third degree AV block without a permanent pacemaker
  • ST-Elevation MI
  • Elevated baseline CK/ CK-MB or troponin levels (Pre-existing Non-STemi)
  • Current pregnancy
  • Patients not already on statin therapy or intolerant of statins

研究组 & 干预措施

1

Other

Either Placebo or Adenosine mixed with normal saline at a concentration of 6 micrograms per milliliter.

干预措施: Adenosine (Drug)

2

Other

Either Placebo or Adenosine mixed with normal saline at a concentration of 6 micrograms per milliliter.

干预措施: Adenosine (Drug)

结局指标

主要结局

Peri-procedural myocardial infarction

时间窗: 24 hours post procedure

次要结局

  • TIMI frame count(Final angiographic picture during the index procedure)
  • Death, myocardial infarction or target lesion revascularization(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Prophylactic Intra-coronary Adenosine to Prevent... | 临床试验