Aortic Stenosis Clinical Trial
Official title:
Radiation-Free Heart Catheterization Using MRI
Verified date | February 2024 |
Source | Children's National Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Currently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to radiation. With this study protocol the investigators will use MRI technology to take real-time pictures to navigate catheters throughout heart chambers. MRI uses electromagnetic energy; therefore, it does not expose participants to radiation energy.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Undergoing a medically necessary cardiovascular catheterization Exclusion Criteria: - Cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support. - Women who are pregnant - Women who are nursing and who do not plan to discard breast milk for 24 hours - Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices: 1. Central nervous system aneurysm clips 2. Implanted neural stimulator 3. Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer 4. Cochlear implant 5. Ocular foreign body (e.g. metal shavings) 6. Implanted Insulin pump 7. Metal shrapnel or bullet Exclusion criteria for Gadolinium (contrast agent) 1. Renal disease with estimated glomerular filtration rate < 30 ml/min/1.73 m2 body surface area |
Country | Name | City | State |
---|---|---|---|
United States | Children's National Health System | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Joshua Kanter |
United States,
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* Note: There are 63 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Test the feasibility of navigating catheters into right heart structures using real-time MRI | Heart catheterization usually uses X-ray guidance. Using commercially available MRI-compatible catheters, the right heart catheterization procedure will be done using real-time magnetic resonance imaging (MRI). MRI guidance does not use X-ray radiation. | At the end of each catheterization procedure through study completion,up to 5 years. | |
Secondary | Number of participants whose MRI cardiac catheterization procedure was prematurely terminated | Premature termination will occur under the following circumstances:
Hemodynamic or other clinical instability Technical failure of catheter procedure such as being unable to navigate the catheters to the heart chamber Equipment malfunction Any other circumstance that in the opinion of the Principal Investigator poses hazard to the research subject |
At the end of each catheterization procedure through study completion,up to 5 years | |
Secondary | Measurement of radiation exposure | Comparison of radiation exposure in this cohort of subjects to historical controls undergoing matched invasive cardiology procedure at CNMC. | End of study, 5 years. |
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