Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273819
Status:
COMPLETED
Last Update Posted:
2009-01-27
First Post:
2006-01-05
Brief Title:
Study of Coronary Artery Disease by Two Types of Angiography
Sponsor:
VA Connecticut Healthcare System
Organization:
VA Connecticut Healthcare System
Study Overview
Official Title:
Non-Invasive Detection of Revascularizable Cardiomyopathy
Status:
COMPLETED
Status Verified Date:
2009-01
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 test the ability of a new X-ray technique called CT angiography to identify significant narrowing of the coronary arteries compared to traditional coronary angiogram
Detailed Description:
Objective
In patients with newly diagnosed cardiomyopathy it is the standard of care to perform coronary angiography This procedure can separate ischemic from non-ischemic cardiomyopathy and identifies patients who may be eligible for revascularization as a therapeutic modality With the advent of multidectector row-computed tomography technology it is becoming possible to non-invasively identify significant atherosclerotic stenoses with acceptable sensitivity and specificity The goal of this study is to compare non-invasive computed tomography CT angiography with traditional coronary angiography to identify proximal and hence revascularizable coronary artery disease in patients with cardiomyopathy Revascularizable is defined a 3 vessel proximal disease left main disease or left main equivalent disease ostial left anterior descending and ostial left circumflex
Research Design
This study is prospective interventional single site with the interpreting radiologists blinded to the results from previous angiography
Methods
Subjects will be patients with cardiomyopathy defined as an ejection fraction less than 40 Exclusion criteria include known allergy to contrast medium previous anaphylaxis and renal insufficiency serum creatinine greater than 15 We would like to enroll 30 patients After giving informed consent all eligible patients will undergo CT angiography performed using new multi-slice technology The results of previously obtained transthoracic echocardiography and standard coronary angiography will be reviewed Following CT angiography all patients will have a repeat measurement of serum creatinine to screen for contrast induced nephropathy Results of the CT angiography will be analyzed to determine sensitivity and specificity for identifying revascularizable coronary artery disease compared to coronary angiography as the gold standard
In patients with newly diagnosed cardiomyopathy it is the standard of care to perform coronary angiography This procedure can separate ischemic from non-ischemic cardiomyopathy and identifies patients who may be eligible for revascularization as a therapeutic modality With the advent of multidectector row-computed tomography technology it is becoming possible to non-invasively identify significant atherosclerotic stenoses with acceptable sensitivity and specificity The goal of this study is to compare non-invasive computed tomography CT angiography with traditional coronary angiography to identify proximal and hence revascularizable coronary artery disease in patients with cardiomyopathy Revascularizable is defined a 3 vessel proximal disease left main disease or left main equivalent disease ostial left anterior descending and ostial left circumflex
Research Design
This study is prospective interventional single site with the interpreting radiologists blinded to the results from previous angiography
Methods
Subjects will be patients with cardiomyopathy defined as an ejection fraction less than 40 Exclusion criteria include known allergy to contrast medium previous anaphylaxis and renal insufficiency serum creatinine greater than 15 We would like to enroll 30 patients After giving informed consent all eligible patients will undergo CT angiography performed using new multi-slice technology The results of previously obtained transthoracic echocardiography and standard coronary angiography will be reviewed Following CT angiography all patients will have a repeat measurement of serum creatinine to screen for contrast induced nephropathy Results of the CT angiography will be analyzed to determine sensitivity and specificity for identifying revascularizable coronary artery disease compared to coronary angiography as the gold standard
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 |
|---|---|---|---|
| 00795 | None | None | None |