Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005562
Status:
COMPLETED
Last Update Posted:
2014-03-13
First Post:
2000-05-25
Brief Title:
Coronary Artery Calcium Exercise Tests and CHD Outcome
Sponsor:
The Cooper Institute
Organization:
The Cooper Institute
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 5400 women and 12600 men will be for an average of about 275 years with approximately 15000 woman-years and 35000 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
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 5400 women and 12600 men will be for an average of about 275 years with approximately 15000 woman-years and 35000 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL062508 | NIH | None | httpsreporternihgovquickSearchR01HL062508 |