Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005256
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Coronary Screening in a High Risk Subset
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-04
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 the incidence of coronary heart disease and cardiovascular mortality could be accurately predicted by the presence of coronary calcific deposits detected by cardiac fluoroscopy
Detailed Description:
BACKGROUND
Because of its low cost and non-invasive nature fluoroscopy was thought to be a potentially powerful screening tool for coronary heart disease if its efficiency could be demonstrated The utility of exercise testing for screening had been limited by its relatively low sensitivity since it could only detect atherosclerotic plaque large enough to significantly impede coronary flow
DESIGN NARRATIVE
Asymptomatic high risk subjects were screened with cardiac fluoroscopy and exercise testing at baseline and followed for six years with annual visits The sensitivity and specificity of fluoroscopy in relation to the incidence of coronary heart disease and the incidence of cardiovascular mortality was determined and compared at 35 and 6 years of follow-up The predictive utility of fluoroscopy and exercise testing in relation to the incidence of coronary events was assessed by logistic regression analysis Multivariate analysis was also performed on baseline risk factors
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Because of its low cost and non-invasive nature fluoroscopy was thought to be a potentially powerful screening tool for coronary heart disease if its efficiency could be demonstrated The utility of exercise testing for screening had been limited by its relatively low sensitivity since it could only detect atherosclerotic plaque large enough to significantly impede coronary flow
DESIGN NARRATIVE
Asymptomatic high risk subjects were screened with cardiac fluoroscopy and exercise testing at baseline and followed for six years with annual visits The sensitivity and specificity of fluoroscopy in relation to the incidence of coronary heart disease and the incidence of cardiovascular mortality was determined and compared at 35 and 6 years of follow-up The predictive utility of fluoroscopy and exercise testing in relation to the incidence of coronary events was assessed by logistic regression analysis Multivariate analysis was also performed on baseline risk factors
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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 |
|---|---|---|---|
| R01HL043277 | NIH | None | httpsreporternihgovquickSearchR01HL043277 |