Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT01479569
Status:
TERMINATED
Last Update Posted:
2018-02-14
First Post:
2011-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pericardiocentesis With Magnetic Resonance Imaging
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Organization:
Study Overview
Official Title:
Real-time MRI Pericardiocentesis Using Passive Needles
Status:
TERMINATED
Status Verified Date:
2017-02-17
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:
Background:
\- Pericardiocentesis uses a needle and small tube to drain fluid from space around the heart. The most common reason to perform this procedure is that the fluid is interfering with heart function. This procedure is usually guided by X-rays. However, researchers want to try the procedure using magnetic resonance imaging (MRI) instead of X-rays. MRI guidance may be more precise than X-rays, which can make the procedure easier and more effective.
Objectives:
\- To test whether MRI guidance can improve pericardiocentesis.
Eligibility:
\- Individuals at least 18 years of age who need to have pericardiocentesis.
Design:
* Participants will have a physical exam before the procedure. Blood samples will be taken.
* The pericardiocentesis will be performed using MRI guidance. The procedure may take up to 2 hours.
* If for some reason the MRI guidance is not successful, participants will have the regular X-ray procedure. The MRI system will be used to take high-quality pictures afterward to check the results....
\- Pericardiocentesis uses a needle and small tube to drain fluid from space around the heart. The most common reason to perform this procedure is that the fluid is interfering with heart function. This procedure is usually guided by X-rays. However, researchers want to try the procedure using magnetic resonance imaging (MRI) instead of X-rays. MRI guidance may be more precise than X-rays, which can make the procedure easier and more effective.
Objectives:
\- To test whether MRI guidance can improve pericardiocentesis.
Eligibility:
\- Individuals at least 18 years of age who need to have pericardiocentesis.
Design:
* Participants will have a physical exam before the procedure. Blood samples will be taken.
* The pericardiocentesis will be performed using MRI guidance. The procedure may take up to 2 hours.
* If for some reason the MRI guidance is not successful, participants will have the regular X-ray procedure. The MRI system will be used to take high-quality pictures afterward to check the results....
Detailed Description:
Pericardiocentesis is a minimally invasive procedure to drain fluid from the pericardial space, created by the pericardial sac which cradles the heart. The most common reason to perform this procedure is that pericardial fluid is interfering with heart function. The next most common reason is to obtain pericardial fluid for testing to make a clinical diagnosis. Pericardiocentesis is performed using a long needle that may be guided by various means including blindly without imaging guidance, using electrocardiography electrodes to determine when the needle accidentally touches the heart, using echocardiography, using X-ray with- or without- contrast injections, or using a combination. Each has its advantages and limitations.
We have developed real-time magnetic resonance imaging (MRI) to guide heart catheterization with tissue visualization but without X-ray radiation. When used to guide needle access to the pericardial space or from there even into heart cavities, MRI provides superb imaging guidance. What is especially valuable about MRI is that it provides the entire thoracic context of needle access, allowing the operator to avoid critical structures including the liver, lung, pleural space, and heart muscle.
We have developed real-time magnetic resonance imaging (MRI) to guide heart catheterization in patients with tissue visualization but without X-ray radiation. We also have used these developments to guide needle access to the heart and pericardium in animal models.
In this protocol we test the safety and feasibility of pericardiocentesis in adult patients, using commercially available MRI-compatible (passive) needles.
If successful, this will enable more advanced minimally invasive procedures in adults and children.
We have developed real-time magnetic resonance imaging (MRI) to guide heart catheterization with tissue visualization but without X-ray radiation. When used to guide needle access to the pericardial space or from there even into heart cavities, MRI provides superb imaging guidance. What is especially valuable about MRI is that it provides the entire thoracic context of needle access, allowing the operator to avoid critical structures including the liver, lung, pleural space, and heart muscle.
We have developed real-time magnetic resonance imaging (MRI) to guide heart catheterization in patients with tissue visualization but without X-ray radiation. We also have used these developments to guide needle access to the heart and pericardium in animal models.
In this protocol we test the safety and feasibility of pericardiocentesis in adult patients, using commercially available MRI-compatible (passive) needles.
If successful, this will enable more advanced minimally invasive procedures in adults and children.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 12-H-0025 | None | None | View |