Cardiovascular DiseasesNCT00005562
Coronary Artery Calcium, Exercise Tests, and CHD Outcome
An observational study of Cardiovascular Diseases and Coronary Disease, run by The Cooper Institute.
Trial summary
To investigate coronary artery calcium (CAC), detected by electron beam computed tomography (EBCT), as a predictor of coronary heart disease (CHD) mortality and morbidity, stroke, and all-cause mortality in a historical cohort epidemiological study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Cerebrovascular Disorders
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1999to Aug 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To investigate coronary artery calcium (CAC), detected by electron beam computed tomography (EBCT), as a predictor of coronary heart disease (CHD) mortality and morbidity, stroke, and all-cause mortality in a historical cohort epidemiological study.
Read the detailed description
BACKGROUND:
Dramatic advances in medical and interventional treatment of clinically overt CHD have contributed substantially, perhaps predominately, to the decline over the past three decades in CHD mortality that has occurred despite relatively unchanged rates of myocardial infarction. By analogy, it is attractive to assume that substantial benefit could also be given to individuals with significant but asymptomatic coronary artery disease if only they could be accurately diagnosed. In this context, research to determine whether or not a non-invasive method like EBCT has sufficient independent predictive value for CHD events to play a useful role in this process has potentially considerable clinical and public health importance.
DESIGN NARRATIVE:
Follow-up of the 5,400 women and 12,600 men will be for an average of about 2.75 years with approximately 15,000 woman-years and 35,000 man-years of observations being available for analyses by June 30, 2000. An important strength of the study is the self-reported key health variables at baseline for all study participants. In addition, objective measures of blood pressure, total cholesterol, HDL- cholesterol, triglyceride, plasma glucose, resting and exercise electrocardiograms (ECG), maximal health rates, cardiorespiratory fitness, and other clinical and biochemical measurements are available for about half of the participants. CAC by EBCT has been associated with prevalent CHD and with incident CHD in recent small prospective studies. However, it is unclear whether CAC is predictive of MI or CHD deaths, because currently available studies had few individuals with evidence of hard CVD endpoints. The large cohort with CAC measurements provides the power to investigate an association between CAC and CHD morbidity, stroke, and all- cause mortality in terms of thresholds or dose-response effects. Exercise test results and measures of conventional CHD risk factors, including several health behaviors and biochemical markers, are available for about 50 percent of the participants. This will allow evaluation of the separate and independent predictive value of CAC and exercise test results and the combination of these two exposures in relation to study outcomes. Furthermore, CAC scores, exercise test results, and the presence of conventional risk factors will be used together to identify participants at the highest risk of developing CHD outcomes.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Cerebrovascular Disorders, Heart Diseases, Cerebrovascular Accident
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Cerebrovascular Disorders, Heart Diseases, Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1999
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
Sponsor and investigators
- Lead sponsor
- The Cooper Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Michael Lamonte, Cooper Institute for Aerobics Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005562
- Sponsor's protocol ID
- 5108
- Other IDs
- R01HL062508
- Status last verified
- Mar 2014
- First submitted
- 25 May 2000
- Last updated
- 13 Mar 2014
- Results posted
- No
Publications
Wei M, Schwertner HA, Blair SN. The association between physical activity, physical fitness, and type 2 diabetes mellitus. Compr Ther. 2000 Fall;26(3):176-82. doi: 10.1007/s12019-000-0006-9.
PubMed 10984822Wei M, Gibbons LW, Mitchell TL, Kampert JB, Blair SN. Alcohol intake and incidence of type 2 diabetes in men. Diabetes Care. 2000 Jan;23(1):18-22. doi: 10.2337/diacare.23.1.18.
PubMed 10857962Wei M, Gibbons LW, Kampert JB, Nichaman MZ, Blair SN. Low cardiorespiratory fitness and physical inactivity as predictors of mortality in men with type 2 diabetes. Ann Intern Med. 2000 Apr 18;132(8):605-11. doi: 10.7326/0003-4819-132-8-200004180-00002.
PubMed 10766678Blair SN, Nichaman MZ. The public health problem of increasing prevalence rates of obesity and what should be done about it. Mayo Clin Proc. 2002 Feb;77(2):109-13. doi: 10.4065/77.2.109. No abstract available.
PubMed 11838643Nguyen-Duy TB, Nichaman MZ, Church TS, Blair SN, Ross R. Visceral fat and liver fat are independent predictors of metabolic risk factors in men. Am J Physiol Endocrinol Metab. 2003 Jun;284(6):E1065-71. doi: 10.1152/ajpendo.00442.2002. Epub 2003 Jan 28.
PubMed 12554597Cheng YJ, Church TS, Kimball TE, Nichaman MZ, Levine BD, McGuire DK, Blair SN. Comparison of coronary artery calcium detected by electron beam tomography in patients with to those without symptomatic coronary heart disease. Am J Cardiol. 2003 Sep 1;92(5):498-503. doi: 10.1016/s0002-9149(03)00714-8.
PubMed 12943866Blair SN, LaMonte MJ, Nichaman MZ. The evolution of physical activity recommendations: how much is enough? Am J Clin Nutr. 2004 May;79(5):913S-920S. doi: 10.1093/ajcn/79.5.913S.
PubMed 15113739Wong SL, Katzmarzyk P, Nichaman MZ, Church TS, Blair SN, Ross R. Cardiorespiratory fitness is associated with lower abdominal fat independent of body mass index. Med Sci Sports Exerc. 2004 Feb;36(2):286-91. doi: 10.1249/01.MSS.0000113665.40775.35.
PubMed 14767252Kuk JL, Nichaman MZ, Church TS, Blair SN, Ross R. Liver fat is not a marker of metabolic risk in lean premenopausal women. Metabolism. 2004 Aug;53(8):1066-71. doi: 10.1016/j.metabol.2004.02.016.
PubMed 15281020Lee S, Janssen I, Ross R. Interindividual variation in abdominal subcutaneous and visceral adipose tissue: influence of measurement site. J Appl Physiol (1985). 2004 Sep;97(3):948-54. doi: 10.1152/japplphysiol.01200.2003. Epub 2004 Apr 30.
PubMed 15121737LaMonte MJ, FitzGerald SJ, Church TS, Barlow CE, Radford NB, Levine BD, Pippin JJ, Gibbons LW, Blair SN, Nichaman MZ. Coronary artery calcium score and coronary heart disease events in a large cohort of asymptomatic men and women. Am J Epidemiol. 2005 Sep 1;162(5):421-9. doi: 10.1093/aje/kwi228. Epub 2005 Aug 2.
PubMed 16076829Barlow CE, LaMonte MJ, Fitzgerald SJ, Kampert JB, Perrin JL, Blair SN. Cardiorespiratory fitness is an independent predictor of hypertension incidence among initially normotensive healthy women. Am J Epidemiol. 2006 Jan 15;163(2):142-50. doi: 10.1093/aje/kwj019. Epub 2005 Nov 17.
PubMed 16293717Jurca R, Lamonte MJ, Barlow CE, Kampert JB, Church TS, Blair SN. Association of muscular strength with incidence of metabolic syndrome in men. Med Sci Sports Exerc. 2005 Nov;37(11):1849-55. doi: 10.1249/01.mss.0000175865.17614.74.
PubMed 16286852LaMonte MJ, Barlow CE, Jurca R, Kampert JB, Church TS, Blair SN. Cardiorespiratory fitness is inversely associated with the incidence of metabolic syndrome: a prospective study of men and women. Circulation. 2005 Jul 26;112(4):505-12. doi: 10.1161/CIRCULATIONAHA.104.503805. Epub 2005 Jul 11.
PubMed 16009797
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Calcium, Exercise Tests, and CHD Outcome
- ClinicalTrials.gov ID
- NCT00005562
- Acronym / sponsor ID
- 5108
- Conditions
- Cardiovascular Diseases, Coronary Disease, Cerebrovascular Disorders, Heart Diseases, Cerebrovascular Accident
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- The Cooper InstituteUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 1999
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 26 May 2000 (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.
To investigate coronary artery calcium (CAC), detected by electron beam computed tomography (EBCT), as a predictor of coronary heart disease (CHD) mortality and morbidity, stroke, and all-cause mortality in a historical cohort epidemiological study.
Detailed description
BACKGROUND:
Dramatic advances in medical and interventional treatment of clinically overt CHD have contributed substantially, perhaps predominately, to the decline over the past three decades in CHD mortality that has occurred despite relatively unchanged rates of myocardial infarction. By analogy, it is attractive to assume that substantial benefit could also be given to individuals with significant but asymptomatic coronary artery disease if only they could be accurately diagnosed. In this context, research to determine whether or not a non-invasive method like EBCT has sufficient independent predictive value for CHD events to play a useful role in this process has potentially considerable clinical and public health importance.
DESIGN NARRATIVE:
Follow-up of the 5,400 women and 12,600 men will be for an average of about 2.75 years with approximately 15,000 woman-years and 35,000 man-years of observations being available for analyses by June 30, 2000. An important strength of the study is the self-reported key health variables at baseline for all study participants. In addition, objective measures of blood pressure, total cholesterol, HDL- cholesterol, triglyceride, plasma glucose, resting and exercise electrocardiograms (ECG), maximal health rates, cardiorespiratory fitness, and other clinical and biochemical measurements are available for about half of the participants. CAC by EBCT has been associated with prevalent CHD and with incident CHD in recent small prospective studies. However, it is unclear whether CAC is predictive of MI or CHD deaths, because currently available studies had few individuals with evidence of hard CVD endpoints. The large cohort with CAC measurements provides the power to investigate an association between CAC and CHD morbidity, stroke, and all- cause mortality in terms of thresholds or dose-response effects. Exercise test results and measures of conventional CHD risk factors, including several health behaviors and biochemical markers, are available for about 50 percent of the participants. This will allow evaluation of the separate and independent predictive value of CAC and exercise test results and the combination of these two exposures in relation to study outcomes. Furthermore, CAC scores, exercise test results, and the presence of conventional risk factors will be used together to identify participants at the highest risk of developing CHD outcomes.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 Mar 2014.
- Background: PubMed 10984822Wei M, Schwertner HA, Blair SN. The association between physical activity, physical fitness, and type 2 diabetes mellitus. Compr Ther. 2000 Fall;26(3):176-82. doi: 10.1007/s12019-000-0006-9.
- Background: PubMed 10857962Wei M, Gibbons LW, Mitchell TL, Kampert JB, Blair SN. Alcohol intake and incidence of type 2 diabetes in men. Diabetes Care. 2000 Jan;23(1):18-22. doi: 10.2337/diacare.23.1.18.
- Background: PubMed 10766678Wei M, Gibbons LW, Kampert JB, Nichaman MZ, Blair SN. Low cardiorespiratory fitness and physical inactivity as predictors of mortality in men with type 2 diabetes. Ann Intern Med. 2000 Apr 18;132(8):605-11. doi: 10.7326/0003-4819-132-8-200004180-00002.
- Background: PubMed 11838643Blair SN, Nichaman MZ. The public health problem of increasing prevalence rates of obesity and what should be done about it. Mayo Clin Proc. 2002 Feb;77(2):109-13. doi: 10.4065/77.2.109. No abstract available.
- Background: PubMed 12554597Nguyen-Duy TB, Nichaman MZ, Church TS, Blair SN, Ross R. Visceral fat and liver fat are independent predictors of metabolic risk factors in men. Am J Physiol Endocrinol Metab. 2003 Jun;284(6):E1065-71. doi: 10.1152/ajpendo.00442.2002. Epub 2003 Jan 28.
- Background: PubMed 12943866Cheng YJ, Church TS, Kimball TE, Nichaman MZ, Levine BD, McGuire DK, Blair SN. Comparison of coronary artery calcium detected by electron beam tomography in patients with to those without symptomatic coronary heart disease. Am J Cardiol. 2003 Sep 1;92(5):498-503. doi: 10.1016/s0002-9149(03)00714-8.
- Background: PubMed 15113739Blair SN, LaMonte MJ, Nichaman MZ. The evolution of physical activity recommendations: how much is enough? Am J Clin Nutr. 2004 May;79(5):913S-920S. doi: 10.1093/ajcn/79.5.913S.
- Background: PubMed 14767252Wong SL, Katzmarzyk P, Nichaman MZ, Church TS, Blair SN, Ross R. Cardiorespiratory fitness is associated with lower abdominal fat independent of body mass index. Med Sci Sports Exerc. 2004 Feb;36(2):286-91. doi: 10.1249/01.MSS.0000113665.40775.35.
- Background: PubMed 15281020Kuk JL, Nichaman MZ, Church TS, Blair SN, Ross R. Liver fat is not a marker of metabolic risk in lean premenopausal women. Metabolism. 2004 Aug;53(8):1066-71. doi: 10.1016/j.metabol.2004.02.016.
- Background: PubMed 15121737Lee S, Janssen I, Ross R. Interindividual variation in abdominal subcutaneous and visceral adipose tissue: influence of measurement site. J Appl Physiol (1985). 2004 Sep;97(3):948-54. doi: 10.1152/japplphysiol.01200.2003. Epub 2004 Apr 30.
- Background: PubMed 16076829LaMonte MJ, FitzGerald SJ, Church TS, Barlow CE, Radford NB, Levine BD, Pippin JJ, Gibbons LW, Blair SN, Nichaman MZ. Coronary artery calcium score and coronary heart disease events in a large cohort of asymptomatic men and women. Am J Epidemiol. 2005 Sep 1;162(5):421-9. doi: 10.1093/aje/kwi228. Epub 2005 Aug 2.
- Background: PubMed 16293717Barlow CE, LaMonte MJ, Fitzgerald SJ, Kampert JB, Perrin JL, Blair SN. Cardiorespiratory fitness is an independent predictor of hypertension incidence among initially normotensive healthy women. Am J Epidemiol. 2006 Jan 15;163(2):142-50. doi: 10.1093/aje/kwj019. Epub 2005 Nov 17.
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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.
Michael Lamonte
Cooper Institute for Aerobics Research
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, run by The Cooper Institute.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005562, which also lists 14 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 Mar 2014.