跳至主要内容
临床试验/NCT01407172
NCT01407172已完成不适用

Hydrogen Sulfide and Peripheral Arterial Disease

Louisiana State University Health Sciences Center Shreveport1 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
252
试验地点
1
主要终点
Free plasma hydrogen sulfide levels

研究概览

简要总结

This will be an observational study comparing the plasma levels of free hydrogen sulfide in patients with and without peripheral arterial disease using a novel recently published method of measuring hydrogen sulfide. The investigators will also see if there is any difference in these levels between symptomatic and asymptomatic patients. Will examine the relationship of these levels to known clinical risk factors as well as plasma nitrite and nitric oxide levels. In doing the above the investigators hope to explore the utility of free hydrogen sulfide as a biomarker for peripheral arterial disease.

Atherosclerotic peripheral arterial disease (PAD) of the lower extremities represents a significant and growing cause of morbidity and mortality. The PARTNERS study of screening ABIs in a primary care population of nearly 7000 individuals demonstrated a remarkable 29% incidence of ABI <0.9, which is the commonly accepted level of abnormal ABI diagnostic of PAD. Also of note in these patients with a new diagnosis of PAD the incidence of asymptomatic PAD was a striking 48%. The availability of a biomarker will greatly enhance the care of these patient and hopefully reduce morbidity and mortality.

The investigators believe that hydrogen sulfide (H2S), an endogenously produced gasotransmitter, holds promise as a clinically useful biomarker for PAD and may also provide a possible explanation for the paradox of asymptomatic PAD in patients with ABIs less than 0.9. To date, research regarding H2S has demonstrated that it participates in a myriad of physiological functions including vasodilatation, anti-apoptotic effects, modulation of mitochondrial respiration, and changes in vascular remodeling.

详细描述

The investigators will conduct an observational cohort study to evaluate H2S levels in three groups of patients:

  1. Patients without PAD as defined by ABI>0.9 and <1.3.
  2. Patients with asymptomatic PAD as defined by ABI<0.9 but no symptoms
  3. Patient with symptomatic PAD as defined by the presence of typical or atypical claudication symptoms or critical limb ischemia in conjunction with ABI <0.9.

This will be a single center study performed at LSUHSC-Shreveport. Patients undergoing cardiac catheterization or peripheral angiogram via a major arterial approach at the LSUHSC cardiac catheterization laboratory meeting the inclusion and exclusion criteria will be eligible and given an opportunity to participate. Those providing informed consent will be interviewed for the presence of claudication symptoms, by use of the San Diego Claudication Questionnaire and the presence of known risk factors for PAD. The medical record will be reviewed for collection of baseline clinical data including known risk factors for vascular disease as well as medications etc. Ankle Brachial Index will be measured by the standard technique of non-invasive measurement of bilateral arm and ankle pressures and recorded in all patients.

Plasma free H2S level quantification via high performance liquid gas chromatography, as well as plasma nitrite levels and nitric oxide levels by chemiluminescence assay will be performed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Patient scheduled at the cardiac catheterization laboratory for coronary or peripheral angiography.
  • Age > 40 years.

排除标准

  • Inability to provide informed consent.
  • ST elevation myocardial infarction.
  • Cardiogenic shock.
  • Non-atherosclerotic PAD (e.g. Buerger's disease).
  • Pregnant or nursing.
  • Enrolment in another clinical trial requiring use of experimental therapeutic agents.
  • ABI > 1.3(indicative of non-compressible vessel needing further evaluation to diagnose PAD), unless documented known PAD.

结局指标

主要结局

Free plasma hydrogen sulfide levels

时间窗: day 1 at enrollment only, we will not be prospectively following these levels.

Will be evaluating plasma free hydrogen sulfide levels in the three cohorts of patients.

次要结局

  • Plasma nitrite and nitric oxide levels.(day 1 at enrollment only, we will not be prospectively following these levels.)

研究者

发起方
Louisiana State University Health Sciences Center Shreveport
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Kevil

Associate Professor - Pathology

Louisiana State University Health Sciences Center Shreveport

研究点 (1)

Loading locations...

相似试验