Clinical trial NCT00918372: Coronary Artery Disease (CAD) in Women Marathon Runners
Official title: Coronary Atherosclerosis in Women Athletes: Asymptomatic Twin Cities Marathon Women Studied by MSCT Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: MSCTA
Marathon runners
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2009-06-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female long distance runners as compared to age and risk-matched controls from both sedentary and fitness activity groups who have never been significant runners, derived from the Minneapolis Heart Institute Foundation's (MHIF) Cross-Sectional Imaging database.

Brief summary: The aim of this study is to determine the effects of extreme fitness in women. The incidence of coronary artery disease observed via multislice computed tomography (MSCT) angiogram will be compared with age and risk-matched controls from both sedentary and fitness activity groups who have never been significant runners. Life style, training volume and risk factors will be assessed.

Detailed description: Single-center, non-randomized, prospective, observational study. The study population will be up to 100 female athletes who are competitive long distance runners, and have been so for a minimum of 10 years. Multi-slice computed tomography (MSCT) will be used to characterize the amount, severity and type of atherosclerotic lesions. MSCTA will be performed per usual practice using a minimum X-ray dose protocol.

The study will determine whether moderate to high intensity, long term athletic training and competition is associated with enhanced coronary artery disease in women. Each participant will complete a life-style, training volume and risk factor questionnaire. These participants will be compared to an age, gender and risk factor matched cohort.

Eligibility criteria: Inclusion Criteria:

* Female athletes who have run marathons competitively for a minimum of 10 years.
* Age \> 40 years old
* Agree to participate and sign an informed consent form

Exclusion Criteria:

* Allergy to X-ray contrast
* Creatinine ≥ 2.0
* Pregnant Female
* Has run a marathon within the past 2 weeks

Primary outcomes:
measure: Evidence of coronary artery disease confirmed by Multislice Computed Tomography
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute at Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Minneapolis Heart Institute Foundation
name: Robert S Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
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