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.
Status | Completed |
Enrollment | 252 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: 1. Patient scheduled at the cardiac catheterization laboratory for coronary or peripheral angiography. 2. Age > 40 years. Exclusion Criteria: 1. Inability to provide informed consent. 2. ST elevation myocardial infarction. 3. Cardiogenic shock. 4. Non-atherosclerotic PAD (e.g. Buerger's disease). 5. Pregnant or nursing. 6. Enrolment in another clinical trial requiring use of experimental therapeutic agents. 7. ABI > 1.3(indicative of non-compressible vessel needing further evaluation to diagnose PAD), unless documented known PAD. |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | LSUHSC Shreveport | Shreveport | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Louisiana State University Health Sciences Center Shreveport |
United States,
Calvert JW, Coetzee WA, Lefer DJ. Novel insights into hydrogen sulfide--mediated cytoprotection. Antioxid Redox Signal. 2010 May 15;12(10):1203-17. doi: 10.1089/ars.2009.2882. Review. — View Citation
Cooke JP, Wilson AM. Biomarkers of peripheral arterial disease. J Am Coll Cardiol. 2010 May 11;55(19):2017-23. doi: 10.1016/j.jacc.2009.08.090. Review. — View Citation
Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24. — View Citation
Shen X, Pattillo CB, Pardue S, Bir SC, Wang R, Kevil CG. Measurement of plasma hydrogen sulfide in vivo and in vitro. Free Radic Biol Med. 2011 May 1;50(9):1021-31. doi: 10.1016/j.freeradbiomed.2011.01.025. Epub 2011 Jan 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Free plasma hydrogen sulfide levels | Will be evaluating plasma free hydrogen sulfide levels in the three cohorts of patients. | day 1 at enrollment only, we will not be prospectively following these levels. | No |
Secondary | Plasma nitrite and nitric oxide levels. | Will evaluate the plasma levels of nitrite and nitric oxide in the three cohorts of patients. | day 1 at enrollment only, we will not be prospectively following these levels. | No |
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