Coronary Artery Disease (CAD) in Women Marathon Runners
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Purpose
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.
| Condition |
|---|
|
Coronary Artery Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Coronary Atherosclerosis in Women Athletes: Asymptomatic Twin Cities Marathon Women Studied by MSCT Angiography |
- Evidence of coronary artery disease confirmed by Multislice Computed Tomography [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | May 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Extreme fitness
Female competitive long distance runners
|
|
Control
Age and Risk matched controls
|
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| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| United States, Minnesota | |
| Minneapolis Heart Institute at Abbott Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| Principal Investigator: | Robert S Schwartz, MD | Minneapolis Heart Institute Foundation |
More Information
Additional Information:
Publications:
| Responsible Party: | Robert Stockton Schwartz, Minneapolis Heart Institute Foundation |
| ClinicalTrials.gov Identifier: | NCT00918372 History of Changes |
| Other Study ID Numbers: | img001 |
| Study First Received: | June 9, 2009 |
| Last Updated: | September 10, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Minneapolis Heart Institute Foundation:
|
MSCTA Marathon runners |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013