Real-time MRI Right Heart Catheterization Using Passive Catheters

NCT01287026 | Completed Phase 1

• 2 other identifiers: 11009111-H-0091
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Currently, heart catheterization procedures are guided by X-rays. Researchers are developing new techniques to perform heart catheterization without the use of X-rays by investigating possible uses of magnetic resonance imaging (MRI) scans. To study these uses, researchers are interested in performing a part of the standard X-ray catheterization procedure using MRI on individuals who are scheduled to have heart catheterization. Objectives: \- To examine the safety and feasibility of right-heart catheterization using MRI-guided catheters. Eligibility: \- Individuals at least 21 years of age who are undergoing a medically necessary heart catheterization procedure. Design:

• The research MRI procedure will be performed either before or after standard X-ray guided heart catheterization.
• Participants will be transferred from an X-ray table onto an MRI table and advanced into the scanner. Under MRI guidance, a MRI-compatible catheter will be used to measure blood pressure and blood oxygen levels in the heart, and MRI scanning will be performed for approximately 30 minutes.

Conditions

Caridovascular Disease; Congenital Heart Disease; Pulmonary Hypertension

Keywords

MRI Catheterization; Right Heart Catheterization; Pulmonary Artery Catheterization; MRI Safety; Jugular Vein Catheterization; Heart Catheterization; Heart Disease; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• To test the initial safety and feasibility of diagnostic right heart catheterization in human subjects using MRI- guidance and

  There will be no heating or adverse events related to the MRI RHC.

  Ongoing

Secondary Outcomes (2)

• To train staff in the conduct of simple MRI catheterization in humans, to accrue incremental experience towards more complex MRI catheterization procedures

  Ongoing

• To test incremental MRI scanning techniques (technical developments) to assist MRI catheterization in humans

  Ongoing

Study Arms (1)

1

EXPERIMENTAL

Open Label

Procedure: Cardiac Real-time MRI RHC (Right Heart Catheterization)

Interventions

Cardiac Real-time MRI RHC (Right Heart Catheterization) PROCEDURE

1

Eligibility Criteria

• Age: 2 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 2 years old
• Undergoing medically necessary diagnostic or interventional right and/or left cardiovascular catheterization

You may not qualify if:

• Cardiovascular instability including ongoing acute myocardial infarction, refractory angina or ischemia, and decompensated congestive heart failure.
• 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 CKD-EPI equation (33):
• eGFR equal 141 x (minimum of (Scr/K, 1)(a) x (maximum of (Scr/K, 1)) (-1.209) x 0.993(Ag x 1.018 (if female) x 1.159 (if black)
• Where\<TAB\>Scr equal serum creatinine
• a = -0.329 for females and -0.411 for males

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 (1)

• Rogers T, Ratnayaka K, Khan JM, Stine A, Schenke WH, Grant LP, Mazal JR, Grant EK, Campbell-Washburn A, Hansen MS, Ramasawmy R, Herzka DA, Xue H, Kellman P, Faranesh AZ, Lederman RJ. CMR fluoroscopy right heart catheterization for cardiac output and pulmonary vascular resistance: results in 102 patients. J Cardiovasc Magn Reson. 2017 Jul 27;19(1):54. doi: 10.1186/s12968-017-0366-2.

  PMID: 28750642 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Hypertension, Pulmonary; Heart Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

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: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: February 1, 2011
• Study Start: February 23, 2011
• Primary Completion: March 21, 2019
• Study Completion: March 21, 2019
• Last Updated: April 5, 2019

Record last verified: 2019-03-21

Locations

US (1)