Status:
TERMINATED
Pericardiocentesis With Magnetic Resonance Imaging
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiac Magnetic Resonance Imaging
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Adult patients, age greater than or equal to 18
- Undergoing medically necessary diagnostic or therapeutic pericardiocentesis
- 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
- Cardiac pacemaker or implantable defibrillator
- Cerebral aneurysm clip
- Neural stimulator (e.g. TENS-Unit)
- Any type of ear implant
- Ocular foreign body (e.g. metal shavings)
- Metal shrapnel or bullet.
- Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe for MRI
- 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:
- This is a technical development study with the prospect of direct benefit to individual research subjects. The selection criteria are designed to minimize risk while attaining the scientific objectives of the study.
- Adult subjects are sought from among patients already undergoing medically necessary pericardiocentesis. Children are excluded from this first proof-of-concept experience to maximize safety; we anticipate a follow-on protocol that includes children.
- Subjects are excluded if they are not suitable for rapid entry into an interventional MRI environment, so mechanical ventilation and cardiogenic shock are exclusion criteria in this early experience.
- Subjects with renal excretory dysfunction might be injured by gadolinium exposure and are not exposed to gadolinium-based contrast agents. Pregnant subjects are excluded because of unknown risk and no benefit to a fetus. Magnetic resonance imaging will be used to guide pericardiocentesis, so subjects must be eligible to undergo magnetic resonance imaging safely.
Exclusion
Key Trial Info
Start Date :
November 8 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2017
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01479569
Start Date
November 8 2011
End Date
February 17 2017
Last Update
February 14 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892