Congenital Heart Disease, Pulmonary Artery Hypertension, Structural Heart Disease
Conditions
Keywords
MRI Catheterization, Real-time MRI
Brief summary
Background: A heart catheterization is a diagnostic heart procedure used to measure pressures and take pictures of the blood flow through the heart chambers. Magnetic resonance imaging (MRI) fluoroscopy shows continuous pictures of the heart chambers that doctors can watch while they work. Researchers want to test this procedure with catheterization tools routinely used in x-ray catheterization called guidewires. Guidewires will help move the heart catheter through the different heart chambers. Guidewires are usually considered unsafe during MRI because MRI can cause a guidewire to heat while inside the blood vessels and heart. Researchers are testing special low energy MRI settings that allow certain guidewires to be used during MRI catheterization without heating. Using these guidewires during MRI may help to decrease the amount of time you are in the MRI scanner, and the overall time the MRI catheterization procedure takes. Objectives: To test if certain MRI settings make it safe to use a guidewire during MRI fluoroscopy. Eligibility: Adults 18 and older whose doctors have recommended right heart catheterization. Design: Researchers will screen participants by reviewing their lab results and questionnaire answers. Participants may give 4 blood samples. Participants will be sedated. They will have a tube (catheter) placed in the groin, arm, or neck if they don t already have one. Patches on the skin will monitor heart rhythm. Special antennas, covered in pads, will be placed against the body. Participants will lie flat on a table that slides in and out of the MRI scanner as it makes pictures. Participants will get earplugs for the loud knocking noise. They can talk on an intercom. They will be inside the scanner for up to 2 hours. They can ask to stop at any time. During a heart catheterization, catheters will be inserted through the tubes already in place. The catheters are guided by MRI fluoroscopy into the chambers of the heart and vessels. The guidewire will help position the catheter.
Detailed description
Heart catheterization is a minimally invasive procedure to measure pressure into specific heart cavities. Heart catheterization usually uses X-ray guidance, which involves radiation exposure, and which fails to visualize soft tissue. For several years, real-time magnetic resonance imaging (MRI) fluoroscopy has been the standard technique to guide right heart catheterization at the NIH clinical center. Guidewires are standard tools used to steer catheters through the body and heart. Guidewires have not been used during MRI fluoroscopy catheterization because of the risk of heating. We have developed MRI techniques that do not risk heating using specific commercial guidewires. In this protocol we will use this new low-energy real-time MRI fluoroscopy technique to enable use of guidewires during otherwise standard MRI catheterization of the right side of the heart through veins, and of the left side of the heart through the aorta. In the second phase of the protocol, we will begin performing systematic MRI guidewire heart catheterization without X-ray whenever possible. We will assess the heart s response to hemodynamic provocation during MRI catheterization tailored to the patient s problem. We will use this protocol to further refine the technique. This will enable future testing of devices for adult and pediatric MRI-fluoroscopy catheterization, which may lead to new non-surgical treatments of cardiovascular disease.
Interventions
DIAGNOSTIC_TESTMRI Heart guidewire catheterization
To conduct left and right heart guidewire catheterization using real-time MRI fluoroscopy in human research subjects already undergoing medically necessary left and right heart catheterization. We will use only passive MRI-compatible catheters and a specific guidewire shown to be safe under specific conditions. Under the conditions of use, the guidewire is not susceptible to heating.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: * Age greater than or equal to 18 years old * Undergoing medically necessary diagnostic or interventional right cardiovascular catheterization, alone or in combination with a 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedure-Related Adverse Events During Low-SAR MRI-Guided Catheterization | During procedure through discharge, up to 4 hours after the procedure | Number of participants with any procedure-related adverse event during MRI-guided cardiac catheterization using passive MRI-compatible catheters and the specified guidewire under defined low-SAR conditions using Common Terminology Criteria for Adverse Events (CTCAE) grading. Events included clinically significant arrhythmia, hemodynamic instability requiring treatment, vascular injury, cardiac perforation/tamponade, device-related heating or burn, or other intervention-related complication. The CTCAE employs a 5-point scale to standardize the grading of adverse events from mild to fatal: * Grade 1 (Mild): Asymptomatic or mild symptoms; no intervention required. * Grade 2 (Moderate): Local/noninvasive intervention needed; limits instrumental ADL. * Grade 3 (Severe): Severe/medically significant; hospitalization or prolongation; limits self-care ADL. * Grade 4 (Life-threatening): Urgent intervention required. * Grade 5 (Fatal): Death related to the adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed the MRI-guided Portion of Cardiac Catheterization Without Life-threatening Hemodynamic Instability | From start of MRI-guided catheterization through completion of the procedure | Life-threatening hemodynamic instability was defined as instability requiring defibrillation, cardioversion, emergency pacing, or pericardiocentesis for cardiac tamponade. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE). The CTCAE employs a 5-point scale to standardize the grading of adverse events from mild to fatal: * Grade 1 (Mild): Asymptomatic or mild symptoms; no intervention required. * Grade 2 (Moderate): Local/noninvasive intervention needed; limits instrumental ADL. * Grade 3 (Severe): Severe/medically significant; hospitalization or prolongation; limits self-care ADL. * Grade 4 (Life-threatening): Urgent intervention required. * Grade 5 (Fatal): Death related to the adverse event |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert J Lederman, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 2 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
None listed