Peripheral Arterial Disease Clinical Trial
Official title:
Hydrogen Sulfide and Peripheral Arterial Disease
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.
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.
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Observational Model: Cohort, Time Perspective: Cross-Sectional
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