Coronary Artery DiseaseNCT00918372
Coronary Artery Disease (CAD) in Women Marathon Runners
An observational study of Coronary Artery Disease, run by Minneapolis Heart Institute Foundation at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Allergy to X-ray contrast
- Creatinine ≥ 2.0
- Pregnant Female
- Has run a marathon within the past 2 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Keywords
- MSCTA, Marathon runners
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Extreme fitness | Female competitive long distance runners | |
| Control | Age and Risk matched controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of coronary artery disease confirmed by Multislice Computed Tomography
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Investigators
- Robert S Schwartz, MD, Principal investigator, Minneapolis Heart Institute Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918372
- Sponsor's protocol ID
- img001
- Status last verified
- Sep 2010
- First submitted
- 9 Jun 2009
- Last updated
- 13 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 3802941Bassler TJ. Coronary-artery disease in marathon runners. N Engl J Med. 1980 Jan 3;302(1):57-8. No abstract available.
PubMed 7350403Colt E. Coronary-artery disease in marathon runners. N Engl J Med. 1980 Jan 3;302(1):57. doi: 10.1056/NEJM198001033020114. No abstract available.
PubMed 7350401Goel 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.
PubMed 17317385Handler 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.
PubMed 7097925Hellerstein HK, Moir TW. Distance running in the 1980s: cardiovascular benefits and risks. Cardiovasc Clin. 1985;15(2):75-86.
PubMed 3912053Lehtonen A, Viikari J. Coronary-artery disease in marathon runners. N Engl J Med. 1980 Jan 3;302(1):57. No abstract available.
PubMed 7350402Maron 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.
PubMed 8800121Mohlenkamp 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.
PubMed 17589430Mohlenkamp 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.
PubMed 17036189Neilan 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.
PubMed 17101848Noakes TD. Heart disease in marathon runners: a review. Med Sci Sports Exerc. 1987 Jun;19(3):187-94.
PubMed 3298928Roberts 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.
PubMed 16198859Schuchert 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.
PubMed 2735089Rowe 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.
PubMed 2019205
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Atherosclerosis in Women Athletes: Asymptomatic Twin Cities Marathon Women Studied by MSCT Angiography
- ClinicalTrials.gov ID
- NCT00918372
- Acronym / sponsor ID
- img001
- Conditions
- Coronary Artery Disease
- Keywords
- MSCTA, Marathon runners
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- May 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extreme fitness | – | –Female competitive long distance runners |
| Control | – | –Age and Risk matched controls |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Allergy to X-ray contrast
- Creatinine ≥ 2.0
- Pregnant Female
- Has run a marathon within the past 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evidence of coronary artery disease confirmed by Multislice Computed Tomography
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2010.
- Background: PubMed 3802941Angeli 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.
- Background: PubMed 7350403Bassler TJ. Coronary-artery disease in marathon runners. N Engl J Med. 1980 Jan 3;302(1):57-8. No abstract available.
- Background: PubMed 7350401Colt E. Coronary-artery disease in marathon runners. N Engl J Med. 1980 Jan 3;302(1):57. doi: 10.1056/NEJM198001033020114. No abstract available.
- Background: PubMed 17317385Goel 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.
- Background: PubMed 7097925Handler 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.
- Background: PubMed 3912053Hellerstein HK, Moir TW. Distance running in the 1980s: cardiovascular benefits and risks. Cardiovasc Clin. 1985;15(2):75-86.
- Background: PubMed 7350402Lehtonen A, Viikari J. Coronary-artery disease in marathon runners. N Engl J Med. 1980 Jan 3;302(1):57. No abstract available.
- Background: PubMed 8800121Maron 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.
- Background: PubMed 17589430Mohlenkamp 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.
- Background: PubMed 17036189Mohlenkamp 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.
- Background: PubMed 17101848Neilan 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.
- Background: PubMed 3298928Noakes TD. Heart disease in marathon runners: a review. Med Sci Sports Exerc. 1987 Jun;19(3):187-94.
- The Minneapolis Heart Institute Foundation improves cardiovascular health through clinical research and educationLink provided by the sponsor.
- The Minneapolis Heart Institute® is recognized internationally as one of the world's leading providers of heart and vascular careLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Schwartz, MD principal investigator
Minneapolis Heart Institute Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Minneapolis Heart Institute Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of coronary artery disease confirmed by Multislice Computed Tomography (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00918372, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2010.