Coronary Artery Disease (CAD) in Women Marathon Runners

This study has been completed.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by:
Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier:
NCT00918372
First received: June 9, 2009
Last updated: September 10, 2010
Last verified: September 2010
  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

Further study details as provided by Minneapolis Heart Institute Foundation:

Primary Outcome Measures:
  • 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
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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918372

Locations
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
Investigators
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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014