Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284466
Status:
COMPLETED
Last Update Posted:
2012-08-29
First Post:
2006-01-27
Brief Title:
Comparing Angiography Multislice CT Versus Invasive Heart Catheterization CACTI
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Comparing Angiography Multislice CT vs Invasive Heart Catheterization CACTI
Status:
COMPLETED
Status Verified Date:
2012-08
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 the study is to compare the pictures of heart arteries obtained by MSCT scanner to the pictures obtained during heart catheterization Our specific question is whether the MSCT scanner is accurate enough to replace heart catheterization in some situations for the evaluation of coronary heart disease
Detailed Description:
QUESTION Compare the accuracy of multi-slice CT angiography CTA with invasive catheterization Cath in detecting and grading coronary lesions
EXPERIMENTAL DESIGN A prospective cohort analysis comparing the quantification of coronary atherosclerosis by Computed Tomographic angiography to that of invasive Catheterization Subjects will be patients who are scheduled for non-urgent cardiac cath based on a clinical need to evaluate the coronary anatomy Cath may be scheduled after a positive stress test or on the basis of concerning symptoms If a patient consents to participation they will be scheduled for CTA no less than 3 and no more than 30 days prior to Cath Comparison of lesions detected by the two imaging modalities in the proximal mid and distal coronary arteries will be made Grades of disease used will be the following 1 less than 50 2 50-75 3 greater than 75 4 Uninterpretable Sensitivity and specificity will be calculated for CTA in addition PPV and NPV will also be calculated The 2 readers of the CTA will be blinded to the invasive angiography results The 2 readers of the invasive angiography who are blinded to the CTA results will be the standard of comparison Analysis of data will be performed on a segmental vessel and patient basis
POTENTIAL RISK Risks associated with contrast exposure include the risk of allergic reaction and renal injury There is a small risk of excessive bradycardia and hypotension with administration of metoprolol and nitroglycerine CTA is associated with radiation exposure similar to the lower range of diagnostic catheterization
POTENTIAL BENEFITS No direct benefits are expected for the subjects of this study as the information will not be used to alter clinical decisions Benefits to future patients may include the development of an non-invasive alternative to cardiac catheterization
EXPERIMENTAL DESIGN A prospective cohort analysis comparing the quantification of coronary atherosclerosis by Computed Tomographic angiography to that of invasive Catheterization Subjects will be patients who are scheduled for non-urgent cardiac cath based on a clinical need to evaluate the coronary anatomy Cath may be scheduled after a positive stress test or on the basis of concerning symptoms If a patient consents to participation they will be scheduled for CTA no less than 3 and no more than 30 days prior to Cath Comparison of lesions detected by the two imaging modalities in the proximal mid and distal coronary arteries will be made Grades of disease used will be the following 1 less than 50 2 50-75 3 greater than 75 4 Uninterpretable Sensitivity and specificity will be calculated for CTA in addition PPV and NPV will also be calculated The 2 readers of the CTA will be blinded to the invasive angiography results The 2 readers of the invasive angiography who are blinded to the CTA results will be the standard of comparison Analysis of data will be performed on a segmental vessel and patient basis
POTENTIAL RISK Risks associated with contrast exposure include the risk of allergic reaction and renal injury There is a small risk of excessive bradycardia and hypotension with administration of metoprolol and nitroglycerine CTA is associated with radiation exposure similar to the lower range of diagnostic catheterization
POTENTIAL BENEFITS No direct benefits are expected for the subjects of this study as the information will not be used to alter clinical decisions Benefits to future patients may include the development of an non-invasive alternative to cardiac catheterization
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