- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02862522
Uric Acid Levels and Endothelial Functions
August 8, 2016 updated by: Amir Lerman, Mayo Clinic
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
229
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Female patients referred to Mayo Clinic's cardiac care clinic in Rochester, Minnesota.
Description
Inclusion Criteria:
- Referred to Mayo Clinic for cardiac catheterization
- Postmenopausal
Exclusion Criteria:
- History of percutaneous coronary intervention
- Coronary artery bypass graft surgery
- Unstable angina pectoris
- Valvular heart disease
- Peripheral vascular disease
- Known congestive heart failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum Uric Acid Level
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1992
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
August 8, 2016
First Submitted That Met QC Criteria
August 8, 2016
First Posted (Estimate)
August 11, 2016
Study Record Updates
Last Update Posted (Estimate)
August 11, 2016
Last Update Submitted That Met QC Criteria
August 8, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-004191
- R01AG031750 (U.S. NIH Grant/Contract)
- R01HL092954 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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