Coronary Artery Disease (CAD) in Women Marathon Runners

NCT ID: NCT00918372

Last Updated: 2010-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Extreme fitness

Female competitive long distance runners

No interventions assigned to this group

Control

Age and Risk matched controls

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Minneapolis Heart Institute Foundation

OTHER

Sponsor Role lead

Responsible Party

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Minneapolis Heart Institute Foundation

Principal Investigators

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Robert S Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Heart Institute Foundation

Locations

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Minneapolis Heart Institute at Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 3802941 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 7350403 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7350401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17317385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7097925 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 3912053 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 7350402 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8800121 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17589430 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17036189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17101848 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 3298928 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16198859 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2735089 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2019205 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 17465632 (View on PubMed)

Related Links

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http://www.mplsheart.org/

The Minneapolis Heart Institute Foundation improves cardiovascular health through clinical research and education

http://www.mplsheart.com

The Minneapolis Heart Institute® is recognized internationally as one of the world's leading providers of heart and vascular care

Other Identifiers

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Identifier Type: -

Identifier Source: org_study_id