NCT00918372

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

September 13, 2010

Status Verified

September 1, 2010

Enrollment Period

1.1 years

First QC Date

June 9, 2009

Last Update Submit

September 10, 2010

Conditions

Keywords

MSCTAMarathon runners

Outcome Measures

Primary Outcomes (1)

  • Evidence of coronary artery disease confirmed by Multislice Computed Tomography

    At enrollment

Study Arms (2)

Extreme fitness

Female competitive long distance runners

Control

Age and Risk matched controls

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Allergy to X-ray contrast
  • Creatinine ≥ 2.0
  • Pregnant Female
  • Has run a marathon within the past 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis Heart Institute at Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Related Publications (16)

  • Angeli SJ, Haft JI. Severe coronary artery disease in a marathon runner. Chest. 1987 Feb;91(2):271-2. doi: 10.1378/chest.91.2.271.

    PMID: 3802941BACKGROUND
  • Bassler TJ. Coronary-artery disease in marathon runners. N Engl J Med. 1980 Jan 3;302(1):57-8. No abstract available.

    PMID: 7350403BACKGROUND
  • Colt E. Coronary-artery disease in marathon runners. N Engl J Med. 1980 Jan 3;302(1):57. doi: 10.1056/NEJM198001033020114. No abstract available.

    PMID: 7350401BACKGROUND
  • Goel R, Majeed F, Vogel R, Corretti MC, Weir M, Mangano C, White C, Plotnick GD, Miller M. Exercise-induced hypertension, endothelial dysfunction, and coronary artery disease in a marathon runner. Am J Cardiol. 2007 Mar 1;99(5):743-4. doi: 10.1016/j.amjcard.2006.09.127. Epub 2007 Jan 11.

    PMID: 17317385BACKGROUND
  • Handler JB, Asay RW, Warren SE, Shea PM. Symptomatic coronary artery disease in a marathon runner. JAMA. 1982 Aug 13;248(6):717-9. No abstract available.

    PMID: 7097925BACKGROUND
  • Hellerstein HK, Moir TW. Distance running in the 1980s: cardiovascular benefits and risks. Cardiovasc Clin. 1985;15(2):75-86.

    PMID: 3912053BACKGROUND
  • Lehtonen A, Viikari J. Coronary-artery disease in marathon runners. N Engl J Med. 1980 Jan 3;302(1):57. No abstract available.

    PMID: 7350402BACKGROUND
  • Maron BJ, Poliac LC, Roberts WO. Risk for sudden cardiac death associated with marathon running. J Am Coll Cardiol. 1996 Aug;28(2):428-31. doi: 10.1016/0735-1097(96)00137-4.

    PMID: 8800121BACKGROUND
  • Mohlenkamp S, Bose D, Mahabadi AA, Heusch G, Erbel R. On the paradox of exercise: coronary atherosclerosis in an apparently healthy marathon runner. Nat Clin Pract Cardiovasc Med. 2007 Jul;4(7):396-401. doi: 10.1038/ncpcardio0926.

    PMID: 17589430BACKGROUND
  • Mohlenkamp S, Schmermund A, Kroger K, Kerkhoff G, Brocker-Preuss M, Adams V, Hensel M, Kiefer D, Lehmann N, Moebus S, Leineweber K, Elsenbruch S, Barkhausen J, Halle M, Hambrecht R, Siegrist J, Mann K, Budde T, Jockel KH, Erbel R. Coronary atherosclerosis and cardiovascular risk in masters male marathon runners. Rationale and design of the "marathon study". Herz. 2006 Sep;31(6):575-85. doi: 10.1007/s00059-006-2879-6.

    PMID: 17036189BACKGROUND
  • Neilan TG, Januzzi JL, Lee-Lewandrowski E, Ton-Nu TT, Yoerger DM, Jassal DS, Lewandrowski KB, Siegel AJ, Marshall JE, Douglas PS, Lawlor D, Picard MH, Wood MJ. Myocardial injury and ventricular dysfunction related to training levels among nonelite participants in the Boston marathon. Circulation. 2006 Nov 28;114(22):2325-33. doi: 10.1161/CIRCULATIONAHA.106.647461. Epub 2006 Nov 13.

    PMID: 17101848BACKGROUND
  • Noakes TD. Heart disease in marathon runners: a review. Med Sci Sports Exerc. 1987 Jun;19(3):187-94.

    PMID: 3298928BACKGROUND
  • Roberts WO, Maron BJ. Evidence for decreasing occurrence of sudden cardiac death associated with the marathon. J Am Coll Cardiol. 2005 Oct 4;46(7):1373-4. doi: 10.1016/j.jacc.2005.07.008. No abstract available.

    PMID: 16198859BACKGROUND
  • Schuchert A, Puschel K, Kupper W, Schafer H, Bleifeld W. [Sudden heart death in a long distance runner during a marathon]. Z Kardiol. 1989 Apr;78(4):276-80. German.

    PMID: 2735089BACKGROUND
  • Rowe WJ. A world record marathon runner with silent ischemia without coronary atherosclerosis. Chest. 1991 May;99(5):1306-8. doi: 10.1378/chest.99.5.1306.

    PMID: 2019205BACKGROUND
  • Tunstall Pedoe DS. Marathon cardiac deaths : the london experience. Sports Med. 2007;37(4-5):448-50. doi: 10.2165/00007256-200737040-00046.

    PMID: 17465632BACKGROUND

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Robert S Schwartz, MD

    Minneapolis Heart Institute Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 11, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

September 13, 2010

Record last verified: 2010-09

Locations