Peripheral Arterial DiseaseNCT01407172
Hydrogen Sulfide and Peripheral Arterial Disease
An observational study of Peripheral Arterial Disease, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patient scheduled at the cardiac catheterization laboratory for coronary or peripheral angiography.
- Age > 40 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The investigators will conduct an observational cohort study to evaluate H2S levels in three groups of patients:
- Patients without PAD as defined by ABI>0.9 and <1.3.
- Patients with asymptomatic PAD as defined by ABI<0.9 but no symptoms
- 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.
- Conditions
- Peripheral Arterial Disease
- Keywords
- PAD, Peripheral arterial disease, Hydrogen Sulfide, Gasotransmitter
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free plasma hydrogen sulfide levels
Will be evaluating plasma free hydrogen sulfide levels in the three cohorts of patients.
Measured: day 1 at enrollment only, we will not be prospectively following these levels.
Secondary outcomes (1)
Plasma nitrite and nitric oxide levels.
Will evaluate the plasma levels of nitrite and nitric oxide in the three cohorts of patients.
Measured: day 1 at enrollment only, we will not be prospectively following these levels.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Kevil, Louisiana State University Health Sciences Center Shreveport
- Investigators
- Christopher Kevil, PhD, Principal investigator, LSUHSC Shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407172
- Sponsor's protocol ID
- H11-110
- Status last verified
- Apr 2013
- First submitted
- 28 Jul 2011
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11560536Shen 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.
PubMed 21276849Cooke 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.
PubMed 20447524Calvert 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.
PubMed 19769484Peter 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.
PubMed 24152982
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrogen Sulfide and Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT01407172
- Acronym / sponsor ID
- H11-110
- Conditions
- Peripheral Arterial Disease
- Keywords
- PAD, Peripheral arterial disease, Hydrogen Sulfide, Gasotransmitter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will conduct an observational cohort study to evaluate H2S levels in three groups of patients:
- Patients without PAD as defined by ABI>0.9 and <1.3.
- Patients with asymptomatic PAD as defined by ABI<0.9 but no symptoms
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patient scheduled at the cardiac catheterization laboratory for coronary or peripheral angiography.
- Age > 40 years.
Key exclusion criteria (7 listed)
- Inability to provide informed consent.
- ST elevation myocardial infarction.
- Cardiogenic shock.
- Non-atherosclerotic PAD (e.g. Buerger's disease).
- Pregnant or nursing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Free plasma hydrogen sulfide levels
Time frame: 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.
1 secondary outcome
Plasma nitrite and nitric oxide levels.
Time frame: day 1 at enrollment only, we will not be prospectively following these levels.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
- Background: PubMed 11560536Hirsch 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.
- Background: PubMed 21276849Shen 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.
- Background: PubMed 20447524Cooke 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.
- Background: PubMed 19769484Calvert 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.
- Derived from this study: PubMed 24152982Peter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Kevil, PhD principal investigator
LSUHSC Shreveport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free plasma hydrogen sulfide levels (time frame: day 1 at enrollment only, we will not be prospectively following these levels.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01407172, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2013.