NCT02862522

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
229

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1992

Longer than P75 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

January 1, 1992

Completed
24.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

24.1 years

First QC Date

August 8, 2016

Last Update Submit

August 8, 2016

Conditions

Keywords

uric acidmicrovascular dysfunctioninflammation

Outcome Measures

Primary Outcomes (1)

  • Serum Uric Acid Level

    Baseline

Study Arms (2)

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.

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.

Other: Questionnaire of overall health

Interventions

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 With CEDWomen Without CED

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients referred to Mayo Clinic's cardiac care clinic in Rochester, Minnesota.

You may qualify if:

  • Referred to Mayo Clinic for cardiac catheterization
  • Postmenopausal

You may not qualify if:

  • History of percutaneous coronary intervention
  • Coronary artery bypass graft surgery
  • Unstable angina pectoris
  • Valvular heart disease
  • Peripheral vascular disease
  • Known congestive heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseInflammation

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amir Lerman, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 11, 2016

Study Start

January 1, 1992

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

August 11, 2016

Record last verified: 2016-08

Locations