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MRI-Guided Heart Catheterization for Cardiac Conditions
N/A
Waitlist Available
Led By Joshua Kanter, MD
Research Sponsored by Joshua Kanter
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing a medically necessary cardiovascular catheterization
Must not have
Cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support
Women who are pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study, 5 years.
Awards & highlights
No Placebo-Only Group
Summary
This trial will use MRI to guide catheters during heart procedures instead of x-ray, which doesn't expose patients to radiation.
Who is the study for?
This trial is for individuals needing heart catheterization, which isn't an emergency. It's not for pregnant or nursing women (unless they can discard breast milk for a day), people with unstable heart conditions, or those who have certain metal implants/devices that make MRI scans unsafe.
What is being tested?
The study is testing a new way to do heart catheterizations using MRI instead of X-rays. This method aims to guide the catheters without exposing patients to radiation, potentially making the procedure safer.
What are the potential side effects?
Since this trial uses MRI technology instead of radiation, there are no radiation-related side effects. However, some may experience discomfort from lying still during the MRI or reactions related to standard risks of catheterization.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a heart-related catheter procedure.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not need drugs or machines to help my heart and circulation function.
Select...
I am currently pregnant.
Select...
My kidney function is severely reduced.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of study, 5 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study, 5 years.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Test the feasibility of navigating catheters into right heart structures using real-time MRI
Secondary study objectives
Measurement of radiation exposure
Number of participants whose MRI cardiac catheterization procedure was prematurely terminated
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MRI guided cardiac catheterizationExperimental Treatment2 Interventions
Magnetic resonance imaging will be used to guide cardiac catheterization procedures.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic resonance imaging
2016
Completed Phase 3
~1240
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Who is running the clinical trial?
Joshua KanterLead Sponsor
1 Previous Clinical Trials
27 Total Patients Enrolled
Joshua Kanter, MDPrincipal Investigator - Children's National Research Institute
Children's National Research Institute
2 Previous Clinical Trials
109 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have an MRI scan if you have certain medical devices inside your body, like a pacemaker or metal shrapnel.I do not need drugs or machines to help my heart and circulation function.I am scheduled for a heart-related catheter procedure.I am currently pregnant.My kidney function is severely reduced.
Research Study Groups:
This trial has the following groups:- Group 1: MRI guided cardiac catheterization
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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