Coronary Screening in a High Risk Subset
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005256
First Posted
May 25, 2000
Last Updated
February 17, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005256
Brief Title
Coronary Screening in a High Risk Subset
Study Type
Observational
2. Study Status
Record Verification Date
April 2000
Overall Recruitment Status
Completed
Study Start Date
May 1990 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 1996 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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 3.5 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Heart Diseases
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
8197979
Citation
Detrano RC, Wong ND, French WJ, Tang W, Georgiou D, Young E, Brezden OS, Doherty T, Brundage BH. Prevalence of fluoroscopic coronary calcific deposits in high-risk asymptomatic persons. Am Heart J. 1994 Jun;127(6):1526-32. doi: 10.1016/0002-8703(94)90381-6.
Results Reference
background
PubMed Identifier
8034867
Citation
Detrano RC, Wong ND, Tang W, French WJ, Georgiou D, Young E, Brezden OS, Doherty TM, Narahara KA, Brundage BH. Prognostic significance of cardiac cinefluoroscopy for coronary calcific deposits in asymptomatic high risk subjects. J Am Coll Cardiol. 1994 Aug;24(2):354-8. doi: 10.1016/0735-1097(94)90287-9.
Results Reference
background
PubMed Identifier
9315534
Citation
Doherty TM, Tang W, Dascalos S, Watson KE, Demer LL, Shavelle RM, Detrano RC. Ethnic origin and serum levels of 1alpha,25-dihydroxyvitamin D3 are independent predictors of coronary calcium mass measured by electron-beam computed tomography. Circulation. 1997 Sep 2;96(5):1477-81. doi: 10.1161/01.cir.96.5.1477.
Results Reference
background
PubMed Identifier
9286939
Citation
Secci A, Wong N, Tang W, Wang S, Doherty T, Detrano R. Electron beam computed tomographic coronary calcium as a predictor of coronary events: comparison of two protocols. Circulation. 1997 Aug 19;96(4):1122-9. doi: 10.1161/01.cir.96.4.1122.
Results Reference
background
PubMed Identifier
9217615
Citation
Detrano RC, Wong ND, Doherty TM, Shavelle R. Prognostic significance of coronary calcific deposits in asymptomatic high-risk subjects. Am J Med. 1997 Apr;102(4):344-9. doi: 10.1016/s0002-9343(97)00085-5.
Results Reference
background
Learn more about this trial
Coronary Screening in a High Risk Subset
We'll reach out to this number within 24 hrs