Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00063531
Status:
COMPLETED
Last Update Posted:
2018-04-18
First Post:
2003-06-30
Brief Title:
Comparison of Two Methods to Diagnose Coronary Artery Disease
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Coronary Disease Detection by Thallium SPECT and Fast CT
Status:
COMPLETED
Status Verified Date:
2018-04
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:
The purpose of this study is to compare two methods of diagnosing coronary artery disease CAD thallium single photon emission computed tomography SPECT and ultrafast computed tomography CT
Detailed Description:
BACKGROUND
The ability to noninvasively detect CAD at a subclinical stage is fundamental to understanding the biology of the transition of occult CAD to clinical CAD in asymptomatic people at the highest risk for future CAD
DESIGN NARRATIVE
The cross-sectional study is designed to identify the factors explaining why some individuals have exercise ischemia without significant coronary artery calcium CAC while others have extensive CAC without exercise ischemia The investigators will compare the pathophysiological features of a functional test for subclinical CAD detection exercise radionuclide perfusion SPECT and an anatomical test to detect coronary calcification ultrafast CT in a high-risk asymptomatic population of 30 to 59 year old siblings of people with premature CAD Siblings will undergo screening for occult CAD using both detection methods Individuals who are abnormal on either test exercise-induced ischemia or calcium score greater than 75th percentile for age and sex will be offered cardiac catheterization which will include quantitative coronary angiography assessment of endothelial function by intracoronary acetylcholine and measurement of plaque volume and composition in a selected coronary artery by intravascular ultrasound IVUS The study will focus on the pathophysiology of occult CAD among individuals who have exercise ischemia with low calcium scores and other individuals who have high calcium scores without ischemia Discrepancies between these two tests measure potentially different biological pathways and such discrepancies are observed frequently in high-risk asymptomatic siblings 40 in our recent pilot study Analyses will be done to determine which biological risk factors can account for variation in plaque calcification that results in discordances between these two measures of occult disease including lipid levels and subclasses Lpa diabetes thrombotic factors pro-inflammatory cytokines and importantly those factors involved in calcium regulation and bone regulatory proteins In those siblings undergoing cardiac catheterization analyses will be done to determine whether the severity or extent of coronary luminal narrowing the presence of epicardial or microvascular endothelial dysfunction or the volume or calcium content of plaque by IVUS can account for discordances between the two screening tests Polymorphisms in several candidate genes that may affect tissue calcification will be examined as a possible explanation for variations in plaque calcification as reflected in test discordance Plasma and DNA will also be collected for novel studies of factors that may account for variability in coronary plaque calcification in this unique well characterized asymptomatic high risk population This will be the first comprehensive study to define the unique biological and genetic factors related to occult CAD as detected by both perfusion imaging and ultrafast CT
The ability to noninvasively detect CAD at a subclinical stage is fundamental to understanding the biology of the transition of occult CAD to clinical CAD in asymptomatic people at the highest risk for future CAD
DESIGN NARRATIVE
The cross-sectional study is designed to identify the factors explaining why some individuals have exercise ischemia without significant coronary artery calcium CAC while others have extensive CAC without exercise ischemia The investigators will compare the pathophysiological features of a functional test for subclinical CAD detection exercise radionuclide perfusion SPECT and an anatomical test to detect coronary calcification ultrafast CT in a high-risk asymptomatic population of 30 to 59 year old siblings of people with premature CAD Siblings will undergo screening for occult CAD using both detection methods Individuals who are abnormal on either test exercise-induced ischemia or calcium score greater than 75th percentile for age and sex will be offered cardiac catheterization which will include quantitative coronary angiography assessment of endothelial function by intracoronary acetylcholine and measurement of plaque volume and composition in a selected coronary artery by intravascular ultrasound IVUS The study will focus on the pathophysiology of occult CAD among individuals who have exercise ischemia with low calcium scores and other individuals who have high calcium scores without ischemia Discrepancies between these two tests measure potentially different biological pathways and such discrepancies are observed frequently in high-risk asymptomatic siblings 40 in our recent pilot study Analyses will be done to determine which biological risk factors can account for variation in plaque calcification that results in discordances between these two measures of occult disease including lipid levels and subclasses Lpa diabetes thrombotic factors pro-inflammatory cytokines and importantly those factors involved in calcium regulation and bone regulatory proteins In those siblings undergoing cardiac catheterization analyses will be done to determine whether the severity or extent of coronary luminal narrowing the presence of epicardial or microvascular endothelial dysfunction or the volume or calcium content of plaque by IVUS can account for discordances between the two screening tests Polymorphisms in several candidate genes that may affect tissue calcification will be examined as a possible explanation for variations in plaque calcification as reflected in test discordance Plasma and DNA will also be collected for novel studies of factors that may account for variability in coronary plaque calcification in this unique well characterized asymptomatic high risk population This will be the first comprehensive study to define the unique biological and genetic factors related to occult CAD as detected by both perfusion imaging and ultrafast CT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL071025 | NIH | None | httpsreporternihgovquickSearchR01HL071025 |