Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091780
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2004-09-16
Brief Title:
Epidemiology of Breast Arterial Calcification
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-02
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 test the hypothesis that breast arterial calcification BAC seen on mammograms can identify women with an increased risk of coronary artery disease CAD
Detailed Description:
BACKGROUND
The study hypothesis is that breast arterial calcification BAC seen on mammograms can identify women with an increased risk of coronary artery disease CAD Annual mammograms are now routinely obtained on nearly 70 of women over forty years of age The nearly 40 million examinations performed every year could be used to evaluate for BAC without any additional cost or change in current mammographic techniques Identification of women with BAC has potential to substantially decrease the rate of heart attack and sudden death due to CAD in asymptomatic women Before BAC can be used in a clinical setting the age-specific prevalence of BAC needs to be fully defined using state of the art mammographic techniques BAC then needs to be compared with well understood CAD risk factors and measures of coronary atherosclerosis While this could be accomplished in a prospective study the same goals can be attained using data already acquired in the Epidemiology of Coronary Calcification ECAC Study
The study uses existing data on 612 non-high risk non-referred women who are participants in the community-based ECAC Study funded by NIH from 1991-2006 This database includes traditional and newer coronary artery disease CAD risk factors and the results of electron beam computed tomography EBCT examinations for CAC at a baseline examination Most of the women also have had risk factors and CAC measured during a follow-up examination on average five years after baseline examinations The women in the ECAC Study who do not have a history of myocardial infarction MI or stroke represent the full age range routinely evaluated with mammograms Almost all these women have their usual care including annual mammograms in Rochester Minnesota
DESIGN NARRATIVE
The ECAC study has been instrumental in establishing the distribution of presence and quantity of CAC as well as the predictors of CAC The database includes clinical and laboratory assessments of CAD risk factors results of EBCTs and findings on physical examinations It will ultimately include information on adverse clinical events There are 612 female participants who had one or more mammograms during the 12-year history of that study Many women had 10 or more mammograms The study will evaluate all of these mammograms for BAC and compare the findings with information already in the database The combination of newly acquired data from mammograms with the existing data allows this to be a very comprehensive study and still be completed in the two-year time period The findings can then be used to help design a future study to prospectively evaluate the impact of instituting preventive and early therapeutic measures for CAD in asymptomatic women with the appropriate features of BAC on mammography
The study hypothesis is that breast arterial calcification BAC seen on mammograms can identify women with an increased risk of coronary artery disease CAD Annual mammograms are now routinely obtained on nearly 70 of women over forty years of age The nearly 40 million examinations performed every year could be used to evaluate for BAC without any additional cost or change in current mammographic techniques Identification of women with BAC has potential to substantially decrease the rate of heart attack and sudden death due to CAD in asymptomatic women Before BAC can be used in a clinical setting the age-specific prevalence of BAC needs to be fully defined using state of the art mammographic techniques BAC then needs to be compared with well understood CAD risk factors and measures of coronary atherosclerosis While this could be accomplished in a prospective study the same goals can be attained using data already acquired in the Epidemiology of Coronary Calcification ECAC Study
The study uses existing data on 612 non-high risk non-referred women who are participants in the community-based ECAC Study funded by NIH from 1991-2006 This database includes traditional and newer coronary artery disease CAD risk factors and the results of electron beam computed tomography EBCT examinations for CAC at a baseline examination Most of the women also have had risk factors and CAC measured during a follow-up examination on average five years after baseline examinations The women in the ECAC Study who do not have a history of myocardial infarction MI or stroke represent the full age range routinely evaluated with mammograms Almost all these women have their usual care including annual mammograms in Rochester Minnesota
DESIGN NARRATIVE
The ECAC study has been instrumental in establishing the distribution of presence and quantity of CAC as well as the predictors of CAC The database includes clinical and laboratory assessments of CAD risk factors results of EBCTs and findings on physical examinations It will ultimately include information on adverse clinical events There are 612 female participants who had one or more mammograms during the 12-year history of that study Many women had 10 or more mammograms The study will evaluate all of these mammograms for BAC and compare the findings with information already in the database The combination of newly acquired data from mammograms with the existing data allows this to be a very comprehensive study and still be completed in the two-year time period The findings can then be used to help design a future study to prospectively evaluate the impact of instituting preventive and early therapeutic measures for CAD in asymptomatic women with the appropriate features of BAC on mammography
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 |
|---|---|---|---|
| R21HL077123 | NIH | None | httpsreporternihgovquickSearchR21HL077123 |