NCT02180074

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2017

Completed
Last Updated

September 2, 2021

Status Verified

June 1, 2014

Enrollment Period

3.7 years

First QC Date

March 18, 2014

Last Update Submit

August 30, 2021

Conditions

Keywords

Hydrogen Sulfide Pools,

Outcome Measures

Primary Outcomes (1)

  • Free Sulfide, Bound Sulfide and Acid Labile Sulfide

    Unit of Measure: nMol

    1 year

Study Arms (5)

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.

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patients presenting to the cardiac catheterization laboratory for coronary or peripheral angiography.
  • Females,Age\>40years

You may not qualify if:

  • Inability to provide informed consent.
  • STelevationmyocardialinfarction.
  • Cardiogenicshock.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSUHSC

Shreveport, Louisiana, 71103, United States

Location

Related Publications (4)

  • 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.

    PMID: 14761901BACKGROUND
  • Hirsch 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.

    PMID: 22343782BACKGROUND
  • 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: 21276849BACKGROUND
  • Shen 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.

    PMID: 22561703BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Christopher Kevil, PhD

    LSUHSC Shreveport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2014

First Posted

July 2, 2014

Study Start

September 1, 2013

Primary Completion

May 7, 2017

Study Completion

May 7, 2017

Last Updated

September 2, 2021

Record last verified: 2014-06

Locations