Hydrogen Sulfide and Peripheral Arterial Disease

NCT01407172 | Completed

• 1 other identifier: H11-110
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Arterial Disease

Keywords

PAD; Peripheral arterial disease; Hydrogen Sulfide; Gasotransmitter

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Plasma nitrite and nitric oxide levels.

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

Study Arms (3)

Symptomatic PAD

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.

Patients without PAD

Patients without PAD as defined by ABI\>0.9 and \<1.3.

Asymptomatic PAD

Patients with asymptomatic PAD as defined by ABI\<0.9 but no symptoms.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead

Study Sites (1)

LSUHSC Shreveport

Shreveport, Louisiana, 71130, United States

Location

Related Publications (5)

• 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. doi: 10.1001/jama.286.11.1317.

  PMID: 11560536 BACKGROUND

• 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.

  PMID: 21276849 BACKGROUND

• 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.

  PMID: 20447524 BACKGROUND

• 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.

  PMID: 19769484 BACKGROUND

• Peter EA, Shen X, Shah SH, Pardue S, Glawe JD, Zhang WW, Reddy P, Akkus NI, Varma J, Kevil CG. Plasma free H2S levels are elevated in patients with cardiovascular disease. J Am Heart Assoc. 2013 Oct 23;2(5):e000387. doi: 10.1161/JAHA.113.000387.

  PMID: 24152982 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma for additional biomarker evaluation will be stored.

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Christopher Kevil, PhD

  LSUHSC Shreveport

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Pathology

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: August 2, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 30, 2013

Record last verified: 2013-04

Locations

US (1)