Ignite Creation Date:
2024-05-05 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00692991
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2008-06-04
Brief Title:
Using Magnetic Resonance Imaging to Evaluate Heart Vessel Function After Angioplasty or Stent Placement Procedures
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Microvascular Obstruction by Contrast-enhanced MRI Following Percutaneous Coronary Interventions
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Coronary artery disease CAD is caused by a narrowing of the blood vessels that supply blood and oxygen to the heart Balloon angioplasty and stent placement are two treatment options for people with reduced heart function caused by CAD This study will use magnetic resonance imaging MRI procedures to evaluate heart function over time in people with CAD who have undergone a balloon angioplasty or stent placement procedure
Detailed Description:
CAD is the most common type of heart disease in the United States It occurs when the arteries that supply blood to the heart become hardened and narrowed because of a build-up of cholesterol and plaque on the inner walls of the arteries Over time less blood is able to flow through the arteries depriving the heart of the blood and oxygen it needs If left untreated CAD can lead to heart failure heart attack and arrhythmias Someone with plaque build-up may undergo a percutaneous coronary intervention PCI to unblock the narrowed arteries and increase blood flow PCI encompasses a variety of procedures including balloon angioplasty and stent placement In balloon angioplasty a small balloon is inserted into the heart artery and then inflated This pushes the plaque against the artery walls and widens the artery Stents are wire mesh tubes that are permanently implanted in the artery to keep it propped open Although balloon angioplasty and stent placement procedures open up blockages in the large vessels of the heart the tiny vessels of the heart may become blocked after these procedures which may affect how the heart heals This study will use MRI to examine heart function in people who have undergone PCI procedures Study researchers will attempt to define how often blockages of the tiny vessels occur after PCI procedures the factors that lead to the blockages and how often blockages affect healing of the heart
This study will enroll people who are undergoing a PCI procedure Participants will undergo an MRI scan of the heart before and after the PCI procedure During the 72 hours after the procedure electrocardiogram EKG will be used to monitor heart electrical activity At a study visit 10 days after the PCI procedure and at a follow-up visit 6 to 12 months later participants will undergo an MRI EKG and blood collection Study staff will call participants every 6 months for 5 years to collect medical information
This study will enroll people who are undergoing a PCI procedure Participants will undergo an MRI scan of the heart before and after the PCI procedure During the 72 hours after the procedure electrocardiogram EKG will be used to monitor heart electrical activity At a study visit 10 days after the PCI procedure and at a follow-up visit 6 to 12 months later participants will undergo an MRI EKG and blood collection Study staff will call participants every 6 months for 5 years to collect medical information
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 |
|---|---|---|---|
| K23HL004444-01 | NIH | None | httpsreporternihgovquickSearchK23HL004444-01 |