Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417625
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-12-30
Brief Title:
Validation of MRI Measurement of Cardiac Blood Flow
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Validation of Cardiac MR Perfusion With Cardiac Catheterization Physiological Assessment
Status:
COMPLETED
Status Verified Date:
2010-07-19
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:
This study will test the accuracy of magnetic resonance imaging MRI in measuring cardiac perfusion blood flow MRI of the heart can measure blood flow to heart muscle but collateral coronary arteries vessels that supply blood to the heart muscle may reduce the accuracy of the measurements This study will perform special measurements of coronary artery flow and pressure in patients undergoing heart catheterization and catheter-based treatment angioplasty and stenting in order to compare for accuracy with cardiac MRI
Patients 21 years of age and older with coronary artery blockage may be eligible for this study All participants undergo cardiac MRI to produce images of the heart as well as special invasive blood flow testing during heart catheterization angioplasty and stenting
During MRI the subject lies on a table that can slide in and out of the scanner a narrow cylinder wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process The procedure lasts about 45 to 90 minutes Since the heart moves during breathing subjects are asked to hold their breath intermittently for about 5-20 seconds A medicine called dipyridamole is injected through a vein in the subjects arm to increase blood flow to the coronary arteries and help detect blockages Pictures are taken of the heart before during and after the dipyridamole injection Another medicine called gadolinium is also given through a vein This medicine brightens the images to measure blood flow
During a separate catheterization angioplasty and stenting procedure subjects undergo additional invasive tests The additional tests use a special guidewire to measure coronary artery pressure and blood flow as well as a special ultrasound to look inside the artery
Patients have a repeat MRI about 2 months after the catheterization
Patients 21 years of age and older with coronary artery blockage may be eligible for this study All participants undergo cardiac MRI to produce images of the heart as well as special invasive blood flow testing during heart catheterization angioplasty and stenting
During MRI the subject lies on a table that can slide in and out of the scanner a narrow cylinder wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process The procedure lasts about 45 to 90 minutes Since the heart moves during breathing subjects are asked to hold their breath intermittently for about 5-20 seconds A medicine called dipyridamole is injected through a vein in the subjects arm to increase blood flow to the coronary arteries and help detect blockages Pictures are taken of the heart before during and after the dipyridamole injection Another medicine called gadolinium is also given through a vein This medicine brightens the images to measure blood flow
During a separate catheterization angioplasty and stenting procedure subjects undergo additional invasive tests The additional tests use a special guidewire to measure coronary artery pressure and blood flow as well as a special ultrasound to look inside the artery
Patients have a repeat MRI about 2 months after the catheterization
Detailed Description:
Cardiac magnetic resonance imaging MRI can measure perfusion blood flow to heart muscle Collateral coronary arteries natural bypasses to the heart may reduce the accuracy of perfusion measured by cardiac MRI
We are testing the accuracy of these measurements in subjects undergoing medically necessary cardiac catheterization and catheter-based treatment angioplasty and stenting We will perform special invasive measurements of coronary artery flow and pressure during catheterization in order to compare with cardiac MRI
We are testing the accuracy of these measurements in subjects undergoing medically necessary cardiac catheterization and catheter-based treatment angioplasty and stenting We will perform special invasive measurements of coronary artery flow and pressure during catheterization in order to compare with cardiac MRI
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 |
|---|---|---|---|
| 07-H-0056 | None | None | None |