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| ID | Type | Description | Link |
|---|---|---|---|
| 12-H-0025 |
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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pericardiocentesis | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Reduce the pericardial effusion. |
| Measure | Description | Time Frame |
|---|---|---|
| To test the feasibility of navigating passive needles percutaneously into the periocardial space using real-time MRI and MRI-compatible needles. |
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EXCLUSION CRITERIA:
Cardiogenic shock (sustained systolic blood pressure less than or equal to 80 mm Hg despite volume repletion on physical examination or requiring catecholamine support)
Women who are pregnant or nursing
Unable to undergo magnetic resonance imaging
EXCLUSION CRITERIA FOR GADOLINIUM-BASED CONTRAST AGENTS:
Renal excretory dysfunction, estimated glomerular filtration rate < 30 mL/min/1.73M(2) body surface area according to the Modification of Diet in Renal Disease criteria
Glomerular filtration rate will be estimated using the MDRD 2005 revised study formula:
--eGFR (mL/min/1.73M(2))=175x(standardized s(cr)) (-1.154) x (age) (-0.203) x 0.742 (if the subject is female) or x1.212 (if the subject is black)
Subjects meeting this exclusion criterion may still be included in the study but may not be exposed to gadolinium-based contrast agents.
RATIONALE FOR SELECTION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Robert J Lederman, M.D. | National Heart, Lung, and Blood Institute (NHLBI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19909937 | Background | Saikus CE, Lederman RJ. Interventional cardiovascular magnetic resonance imaging: a new opportunity for image-guided interventions. JACC Cardiovasc Imaging. 2009 Nov;2(11):1321-31. doi: 10.1016/j.jcmg.2009.09.002. | |
| 19114017 | Background | Ratnayaka K, Faranesh AZ, Guttman MA, Kocaturk O, Saikus CE, Lederman RJ. Interventional cardiovascular magnetic resonance: still tantalizing. J Cardiovasc Magn Reson. 2008 Dec 29;10(1):62. doi: 10.1186/1532-429X-10-62. |
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| ID | Term |
|---|---|
| D020519 | Pericardiocentesis |
| ID | Term |
|---|---|
| D019152 | Paracentesis |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 12549231 | Background | Guttman MA, Lederman RJ, Sorger JM, McVeigh ER. Real-time volume rendered MRI for interventional guidance. J Cardiovasc Magn Reson. 2002;4(4):431-42. doi: 10.1081/jcmr-120016382. |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
| D008919 | Investigative Techniques |