Pericardiocentesis With Magnetic Resonance Imaging

NCT01479569 | Terminated Phase 1

• 2 other identifiers: 12002512-H-0025
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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....

Conditions

Cardiac Magnetic Resonance Imaging

Keywords

MRI Catheterization; Pericardiocentesis; MRI Safety; Cardiac Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Reduce the pericardial effusion.

Secondary Outcomes (1)

• To test the feasibility of navigating passive needles percutaneously into the periocardial space using real-time MRI and MRI-compatible needles.

Interventions

Pericardiocentesis PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, age greater than or equal to 18
• Undergoing medically necessary diagnostic or therapeutic pericardiocentesis

You may not qualify if:

• 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
• 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)
• 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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 19909937 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.

  PMID: 19114017 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.

  PMID: 12549231 BACKGROUND

MeSH Terms

Interventions

Pericardiocentesis

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures; Investigative Techniques

Study Officials

• Robert J Lederman, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: November 8, 2011
• Primary Completion: February 17, 2017
• Study Completion: February 17, 2017
• Last Updated: February 14, 2018

Record last verified: 2017-02-17

Locations

US (1)