CompletedPhase 1/2

Real-time MRI Right Heart Catheterization Using Passive Catheters

United States150 participantsStarted 2011-02-23

Plain-language 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.

Who can participate

Age range2 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: Age greater than or equal to 2 years old Undergoing medically necessary diagnostic or interventional right and/or left cardiovascular catheterization EXCLUSION CRITERIA : 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 EXCLUSION CRITERIA FOR GADOLINIUM-BASED CONTRAST AGENTS FOR ADULTS: 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 k = 0.7 for females and 0.9 for males Subjects meeting this exclusion criterion may still be included in the study but may not be exposed to gadolinium-based contrast agents. EXCLUSION CRITERIA FOR GADOLINIUM-BASED CONTRAST AG…

What they're measuring

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

Timeframe: Ongoing

Trial details

NCT IDNCT01287026

SponsorNational Heart, Lung, and Blood Institute (NHLBI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2019-03-21