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Completed

NCT Number: NCT00918372

Coronary Artery Disease (CAD) in Women Marathon Runners

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Minneapolis Heart Institute at Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evidence of coronary artery disease confirmed by Multislice Computed Tomography

    Time frame: At enrollment

Sponsors and collaborators

Lead sponsor

Minneapolis Heart Institute Foundation

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

Coronary Atherosclerosis in Women Athletes: Asymptomatic Twin Cities Marathon Women Studied by MSCT Angiography

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 11, 2009
Registry last updated
Sep 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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