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NCT00918372 Clinical Trial

Coronary Artery Disease (CAD) in Women Marathon Runners

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00918372
Other study ID # img001
Secondary ID
Status Completed
Phase N/A
First received June 9, 2009
Last updated September 10, 2010
Start date May 2009
Est. completion date June 2010

Study information
Verified date September 2010
Source Minneapolis Heart Institute Foundation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States Minneapolis Heart Institute at Abbott Northwestern Hospital Minneapolis Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Minneapolis Heart Institute Foundation Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (16)

Angeli SJ, Haft JI. Severe coronary artery disease in a marathon runner. Chest. 1987 Feb;91(2):271-2. — View Citation

Bassler TJ. Coronary-artery disease in marathon runners. N Engl J Med. 1980 Jan 3;302(1):57-8. — View Citation

Colt E. Coronary-artery disease in marathon runners. N Engl J Med. 1980 Jan 3;302(1):57. — View Citation

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. Epub 2007 Jan 11. — View Citation

Handler JB, Asay RW, Warren SE, Shea PM. Symptomatic coronary artery disease in a marathon runner. JAMA. 1982 Aug 13;248(6):717-9. — View Citation

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

Lehtonen A, Viikari J. Coronary-artery disease in marathon runners. N Engl J Med. 1980 Jan 3;302(1):57. — View Citation

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. — View Citation

Möhlenkamp S, Böse 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. — View Citation

Möhlenkamp S, Schmermund A, Kröger K, Kerkhoff G, Bröcker-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, Jöckel 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. — View Citation

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. Epub 2006 Nov 13. — View Citation

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

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. — View Citation

Rowe WJ. A world record marathon runner with silent ischemia without coronary atherosclerosis. Chest. 1991 May;99(5):1306-8. — View Citation

Schuchert A, Püschel K, Kupper W, Schäfer H, Bleifeld W. [Sudden heart death in a long distance runner during a marathon]. Z Kardiol. 1989 Apr;78(4):276-80. German. — View Citation

Tunstall Pedoe DS. Marathon cardiac deaths : the london experience. Sports Med. 2007;37(4-5):448-50. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Evidence of coronary artery disease confirmed by Multislice Computed Tomography At enrollment No
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