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临床试验/NCT00982852
NCT00982852终止不适用

Intravascular Ultrasound Derived Virtual Histology and Intracoronary Serum Markers of Inflammation in Patients Referred for Percutaneous Coronary Intervention.

Quinn Capers1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
9
试验地点
1
主要终点
Occurrence or absence of adverse cardiovascular outcomes up to 36 months after PCI

研究概览

简要总结

Patients enrolled will need treated with an IVUS- VH (intravascular ultrasound-derived virtual histology) which is an arterial stent procedure, that involves threading a tiny wire into the artery, followed by a balloon, a stent, or other device to treat a blocked artery, and often (though not always), a special ultrasound catheter to take pictures of the inside of the artery.

Participants in the study, will have an additional procedure performed: a tiny tube will be advanced into the heart artery to collect a blood sample for research purposes, and a blood sample will be collected from the femoral (thigh) artery through the tube that will be placed there as a standard part of having this procedure.

The blood that is collected will be analyzed for markers of inflammation or irritation in the blood (c-reactive protein, myeloperoxidase, Monocyte chemotactic protein-1), as well and a gene called Matrix Metallopeptidase 3, which is believe to influence the progression of plaque on the walls of arteries and the progression of coronary artery disease. .

详细描述

Patients that have severe blockage in one of the arteries that provides blood flow to your heart will be enrolled into the research study. Most of the procedures in the study standard care used by cardiologists when treating blocked arteries. Patients enrolled will need treated with an IVUS- VH (intravascular ultrasound-derived virtual histology) which is an arterial stent procedure, that involves threading a tiny wire into the artery, followed by a balloon, a stent, or other device to treat a blocked artery, and often (though not always), a special ultrasound catheter to take pictures of the inside of the artery. We will collect all the data from the above stated standard medical care procedure.

Participants in the study, will have an additional procedure performed: a tiny tube will be advanced into the heart artery to collect a blood sample for research purposes, and a blood sample will be collected from the femoral (thigh) artery through the tube that will be placed there as a standard part of having this procedure.

The blood that is collected will be analyzed for markers of inflammation or irritation in the blood (c-reactive protein, myeloperoxidase, Monocyte chemotactic protein-1), as well and a gene called Matrix Metallopeptidase 3, which is believe to influence the progression of plaque on the walls of arteries and the progression of coronary artery disease. .

Finally, after discharged from the hospital, the research nurses will call you at home to ask you questions about how you are doing for approximately 5-10 minutes. Telephone follow-up will occur at one month, six months, 12 months, 18 months, 24 months, and 36 months.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • In- or out-patients admitted to IPR or hospital floor for left heart catheterization or scheduled angioplasty
  • 18 years or older
  • Able to provide informed consent

排除标准

  • Patients who are pregnant or lactating
  • Inability to provide informed consent
  • Patients undergoing heart catheterization for who open heart surgery is planned
  • Anticipate being unavailable for telephone follow-up

结局指标

主要结局

Occurrence or absence of adverse cardiovascular outcomes up to 36 months after PCI

时间窗: 36 months

次要结局

未报告次要终点

研究者

发起方
Quinn Capers
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Quinn Capers

Professor

Ohio State University

研究点 (1)

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