Cardiovascular DiseaseNCT02180074
Measurement of Distinct Biological Pools of Hydrogen Sulfide in Women With Cardiovascular Disease
An observational study of Cardiovascular Disease, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial summary
Cardiovascular disease which includes coronary artery disease and peripheral artery disease remains the leading cause of death among women in the United States. The impact of cardiovascular in women was not recognized by clinicians for a long time. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 7 May 2017
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female subjects scheduled to undergo left heart catheterization or peripheral angiography at LSUHSC Shreveport cardiac catheterization laboratory will be given the opportunity to participate. Controls will be recruited via flyers posted in various parts of LSUHSC Shreveport.
Who may be able to join
- Patients presenting to the cardiac catheterization laboratory for coronary or peripheral angiography.
- Females,Age>40years
Who cannot join
- Inability to provide informed consent.
- STelevationmyocardialinfarction.
- Cardiogenicshock.
- 3. ABI >1.4 (indicative of non-compressible vessel needing further evaluation to diagnose PAD), unless documented known PAD. 4. Non-atheroscleroticPAD(e.g.Buerger'sdisease). 5. Enrolment in another clinical trial with use of experimental therapeutic agents.
Trial locations and contacts
1 site in 1 country.
About this study
Cardiovascular disease which includes coronary artery disease and peripheral artery disease remains the leading cause of death among women in the United States. The impact of cardiovascular in women was not recognized by clinicians for a long time. It is now evident that, women suffer the consequences of cardiovascular at rates at least as high as those observed in men but there are still major gaps in our understanding this disease in women. Hydrogen sulfide (H2S), a gaseous mediator plays an important role in the cardiovascular system. Research has demonstrated it's critical role in animal ischemia reperfusion models. Hydrogen sulfide exists in distinct biological pools in blood. Recently, the Kevil lab has pioneered the development of new analytical techniques for accurate measurement of all biological pools of H2S. By measuring these distinct pools of H2S in women with and without cardiovascular disease the investigators hope to further understanding of role of H2S in pathophysiology of cardiovascular disease. This research will help to assess the ability of H2S and its distinct biological pools to potentially be a diagnostic marker or a therapeutic target for cardiovascular disease.
- Conditions
- Cardiovascular Disease
- Keywords
- Hydrogen Sulfide Pools,
- Medical subject headings
- Cardiovascular Diseases
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 |
|---|---|---|
| I | Women without PAD (ABI >1.0 and <1.4) or CAD, and < 2 risk factors for cardiovascular disease (to serve as healthy controls) | |
| II | Women without PAD (ABI>1.0 and <1.4) or CAD and > 2 risk factors for cardiovascular disease | |
| III | Women with PAD as defined by ABI <0.9 and a coronary angiogram without any significant coronary artery disease. | |
| IV | Women with CAD without PAD, as defined by >50% stenosis by coronary angiography and ABI >1.0 and <1.4. | |
| V | Women with both CAD and PAD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free Sulfide, Bound Sulfide and Acid Labile Sulfide
Unit of Measure: nMol
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startSep 2013
- Primary completion7 May 2017
- Study completion7 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 137 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
- NCT02180074
- Sponsor's protocol ID
- SRKH2SPOOLS
- Status last verified
- Jun 2014
- First submitted
- 18 Mar 2014
- Last updated
- 2 Sep 2021
- Results posted
- No
Publications
Mosca L, Ferris A, Fabunmi R, Robertson RM; American Heart Association. Tracking women's awareness of heart disease: an American Heart Association national study. Circulation. 2004 Feb 10;109(5):573-9. doi: 10.1161/01.CIR.0000115222.69428.C9. Epub 2004 Feb 4.
PubMed 14761901Hirsch AT, Allison MA, Gomes AS, Corriere MA, Duval S, Ershow AG, Hiatt WR, Karas RH, Lovell MB, McDermott MM, Mendes DM, Nussmeier NA, Treat-Jacobson D; American Heart Association Council on Peripheral Vascular Disease; Council on Cardiovascular Nursing; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology; Council on Epidemiology and Prevention. A call to action: women and peripheral artery disease: a scientific statement from the American Heart Association. Circulation. 2012 Mar 20;125(11):1449-72. doi: 10.1161/CIR.0b013e31824c39ba. Epub 2012 Feb 15. No abstract available.
PubMed 22343782Shen 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 21276849Shen X, Peter EA, Bir S, Wang R, Kevil CG. Analytical measurement of discrete hydrogen sulfide pools in biological specimens. Free Radic Biol Med. 2012 Jun 1-15;52(11-12):2276-83. doi: 10.1016/j.freeradbiomed.2012.04.007. Epub 2012 Apr 19.
PubMed 22561703
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Distinct Biological Pools of Hydrogen Sulfide in Women With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT02180074
- Acronym / sponsor ID
- SRKH2SPOOLS
- Conditions
- Cardiovascular Disease
- Keywords
- Hydrogen Sulfide Pools,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- 7 May 2017 (actual)
- Study completion
- 7 May 2017 (actual)
- First posted
- 2 Jul 2014 (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.
Cardiovascular disease which includes coronary artery disease and peripheral artery disease remains the leading cause of death among women in the United States. The impact of cardiovascular in women was not recognized by clinicians for a long time. It is now evident that, women suffer the consequences of cardiovascular at rates at least as high as those observed in men but there are still major gaps in our understanding this disease in women. Hydrogen sulfide (H2S), a gaseous mediator plays an important role in the cardiovascular system. Research has demonstrated it's critical role in animal ischemia reperfusion models. Hydrogen sulfide exists in distinct biological pools in blood. Recently, the Kevil lab has pioneered the development of new analytical techniques for accurate measurement of all biological pools of H2S. By measuring these distinct pools of H2S in women with and without cardiovascular disease the investigators hope to further understanding of role of H2S in pathophysiology of cardiovascular disease. This research will help to assess the ability of H2S and its distinct biological pools to potentially be a diagnostic marker or a therapeutic target for cardiovascular disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| I | – | –Women without PAD (ABI >1.0 and <1.4) or CAD, and < 2 risk factors for cardiovascular disease (to serve as healthy controls) |
| II | – | –Women without PAD (ABI>1.0 and <1.4) or CAD and > 2 risk factors for cardiovascular disease |
| III | – | –Women with PAD as defined by ABI <0.9 and a coronary angiogram without any significant coronary artery disease. |
| IV | – | –Women with CAD without PAD, as defined by >50% stenosis by coronary angiography and ABI >1.0 and <1.4. |
| V | – | –Women with both CAD and PAD. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female subjects scheduled to undergo left heart catheterization or peripheral angiography at LSUHSC Shreveport cardiac catheterization laboratory will be given the opportunity to participate. Controls will be recruited via flyers posted in various parts of LSUHSC Shreveport.
Key inclusion criteria (2 listed)
- Patients presenting to the cardiac catheterization laboratory for coronary or peripheral angiography.
- Females,Age>40years
Key exclusion criteria (4 listed)
- Inability to provide informed consent.
- STelevationmyocardialinfarction.
- Cardiogenicshock.
- 3. ABI >1.4 (indicative of non-compressible vessel needing further evaluation to diagnose PAD), unless documented known PAD. 4. Non-atheroscleroticPAD(e.g.Buerger'sdisease). 5. Enrolment in another clinical trial with use of experimental therapeutic agents.
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 Sulfide, Bound Sulfide and Acid Labile Sulfide
Time frame: 1 year
Unit of Measure: nMol
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 2 Sep 2021.
- Background: PubMed 14761901Mosca L, Ferris A, Fabunmi R, Robertson RM; American Heart Association. Tracking women's awareness of heart disease: an American Heart Association national study. Circulation. 2004 Feb 10;109(5):573-9. doi: 10.1161/01.CIR.0000115222.69428.C9. Epub 2004 Feb 4.
- Background: PubMed 22343782Hirsch AT, Allison MA, Gomes AS, Corriere MA, Duval S, Ershow AG, Hiatt WR, Karas RH, Lovell MB, McDermott MM, Mendes DM, Nussmeier NA, Treat-Jacobson D; American Heart Association Council on Peripheral Vascular Disease; Council on Cardiovascular Nursing; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology; Council on Epidemiology and Prevention. A call to action: women and peripheral artery disease: a scientific statement from the American Heart Association. Circulation. 2012 Mar 20;125(11):1449-72. doi: 10.1161/CIR.0b013e31824c39ba. Epub 2012 Feb 15. No abstract available.
- 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 22561703Shen X, Peter EA, Bir S, Wang R, Kevil CG. Analytical measurement of discrete hydrogen sulfide pools in biological specimens. Free Radic Biol Med. 2012 Jun 1-15;52(11-12):2276-83. doi: 10.1016/j.freeradbiomed.2012.04.007. Epub 2012 Apr 19.
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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 Cardiovascular 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 4 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 2 Sep 2021. 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 Sulfide, Bound Sulfide and Acid Labile Sulfide (time frame: 1 year). 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 NCT02180074, which also lists 4 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 2 Sep 2021.