Coronary Artery Disease (CAD) in Women Marathon Runners

September 10, 2010 updated by: Minneapolis Heart Institute Foundation

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute at Abbott Northwestern Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Extreme fitness
Female competitive long distance runners
Control
Age and Risk matched controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of coronary artery disease confirmed by Multislice Computed Tomography
Time Frame: At enrollment
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minneapolis Heart Institute Foundation

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Robert S Schwartz, MD, Minneapolis Heart Institute Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 10, 2009

First Posted (Estimate)

June 11, 2009

Study Record Updates

Last Update Posted (Estimate)

September 13, 2010

Last Update Submitted That Met QC Criteria

September 10, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • img001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe