Real-time MRI Right Heart Catheterization Using Passive Catheters (NCT01287026) | Clinical Trial Compass
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 range
2 Years – 99 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)