We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Coronary Artery Disease (CAD) in Women Marathon Runners

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00918372
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : September 13, 2010
Boston Scientific Corporation
Information provided by:
Minneapolis Heart Institute Foundation

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.

Condition or disease
Coronary Artery Disease

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.

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Coronary Atherosclerosis in Women Athletes: Asymptomatic Twin Cities Marathon Women Studied by MSCT Angiography
Study Start Date : May 2009
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Extreme fitness
Female competitive long distance runners
Age and Risk matched controls

Primary Outcome Measures :
  1. Evidence of coronary artery disease confirmed by Multislice Computed Tomography [ Time Frame: At enrollment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918372

United States, Minnesota
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Minneapolis Heart Institute Foundation
Boston Scientific Corporation
Principal Investigator: Robert S Schwartz, MD Minneapolis Heart Institute Foundation

Additional Information:

Responsible Party: Robert Stockton Schwartz, Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier: NCT00918372     History of Changes
Other Study ID Numbers: img001
First Posted: June 11, 2009    Key Record Dates
Last Update Posted: September 13, 2010
Last Verified: September 2010

Keywords provided by Minneapolis Heart Institute Foundation:
Marathon runners

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases