Coronary Artery DiseaseNCT02862522
Uric Acid Levels and Endothelial Functions
An observational study of Coronary Artery Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
Uric acid is a risk factor for coronary artery disease (CED) in postmenopausal women but the association with inflammation and coronary microvascular endothelial dysfunction is not well-defined. The aim of this study was to determine the relationship of serum uric acid, inflammatory markers and CED. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Questionnaire of overall health
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1992to Feb 2016
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients referred to Mayo Clinic's cardiac care clinic in Rochester, Minnesota.
Who may be able to join
- Referred to Mayo Clinic for cardiac catheterization
- Postmenopausal
Who cannot join
- History of percutaneous coronary intervention
- Coronary artery bypass graft surgery
- Unstable angina pectoris
- Valvular heart disease
- Peripheral vascular disease
- Known congestive heart failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Follow-up of Patients With Assessment of Endothelial Dysfunction/Coronary Spasm
Uric acid is a risk factor for coronary artery disease (CED) in postmenopausal women but the association with inflammation and coronary microvascular endothelial dysfunction is not well-defined. The aim of this study was to determine the relationship of serum uric acid, inflammatory markers and CED.
- Conditions
- Coronary Artery Disease
- Being tested
- Questionnaire of overall health
- Keywords
- uric acid, microvascular dysfunction, inflammation
- Medical subject headings
- Coronary Artery Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire of overall healthOther
The standardized questionnaire was used to assess occurrence of major adverse cardiovascular events including stroke, re-hospitalization, myocardial infarction or death. Responses were verified by medical record review conducted by an investigator blinded to the results of the standardized questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Women With CED | All subjects had blood work with included measurement of C-reactive protein, complete blood count with differential, basic chemistry panel, and uric acid level. All subjects completed a standardized questionnaire to assess baseline characteristics. All subjects underwent comprehensive coronary endothelial function assessment. Subjects completed a questionnaire of overall health several years after the index coronary angiogram and endothelial function study. Receives: Other: Questionnaire of overall health | |
| Women Without CED | All subjects had blood work with included measurement of C-reactive protein, complete blood count with differential, basic chemistry panel, and uric acid level. All subjects completed a standardized questionnaire to assess baseline characteristics. All subjects underwent comprehensive coronary endothelial function assessment. Subjects completed a questionnaire of overall health several years after the index coronary angiogram and endothelial function study. Receives: Other: Questionnaire of overall health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Uric Acid Level
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startJan 1992
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Amir Lerman, Mayo Clinic
- Investigators
- Amir Lerman, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862522
- Sponsor's protocol ID
- 05-004191
- Other IDs
- R01HL092954, R01AG031750
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Follow-up of Patients With Assessment of Endothelial Dysfunction/Coronary Spasm
- ClinicalTrials.gov ID
- NCT02862522
- Acronym / sponsor ID
- 05-004191
- Conditions
- Coronary Artery Disease
- Keywords
- uric acid, microvascular dysfunction, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA)
- Study start
- Jan 1992
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 11 Aug 2016 (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.
Uric acid is a risk factor for coronary artery disease (CED) in postmenopausal women but the association with inflammation and coronary microvascular endothelial dysfunction is not well-defined. The aim of this study was to determine the relationship of serum uric acid, inflammatory markers and CED.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women With CED | – | Other: Questionnaire of overall healthAll subjects had blood work with included measurement of C-reactive protein, complete blood count with differential, basic chemistry panel, and uric acid level. All subjects completed a standardized questionnaire to assess baseline characteristics. All subjects underwent comprehensive coronary endothelial function assessment. Subjects completed a questionnaire of overall health several years after the index coronary angiogram and endothelial function study. |
| Women Without CED | – | Other: Questionnaire of overall healthAll subjects had blood work with included measurement of C-reactive protein, complete blood count with differential, basic chemistry panel, and uric acid level. All subjects completed a standardized questionnaire to assess baseline characteristics. All subjects underwent comprehensive coronary endothelial function assessment. Subjects completed a questionnaire of overall health several years after the index coronary angiogram and endothelial function study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients referred to Mayo Clinic's cardiac care clinic in Rochester, Minnesota.
Key inclusion criteria (2 listed)
- Referred to Mayo Clinic for cardiac catheterization
- Postmenopausal
Key exclusion criteria (6 listed)
- History of percutaneous coronary intervention
- Coronary artery bypass graft surgery
- Unstable angina pectoris
- Valvular heart disease
- Peripheral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire of overall healthThe standardized questionnaire was used to assess occurrence of major adverse cardiovascular events including stroke, re-hospitalization, myocardial infarction or death. Responses were verified by medical record review conducted by an investigator blinded to the results of the standardized questionnaire. | Other | Women With CED, Women Without CED |
Primary outcome
Serum Uric Acid Level
Time frame: Baseline
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 11 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
Amir Lerman, M.D. principal investigator
Mayo Clinic
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 Coronary Artery Disease, run by Mayo Clinic 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 6 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 11 Aug 2016. 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?
Serum Uric Acid Level (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2016.