Imaging for Aortic Valve Stenosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new imaging method to better understand heart conditions. It uses a special radioligand called 11C-Martinostat with PET-MRI scanning to evaluate its effectiveness in different groups: those with aortic stenosis (a narrowing of the heart's aortic valve), individuals with diabetes, and healthy participants. The goal is to compare heart images between these groups before and after certain treatments. Suitable candidates include those with diabetes, aortic stenosis, or healthy individuals with no heart issues. Those with aortic stenosis or diabetes, or healthy individuals interested in contributing to heart research, may find this trial a good fit. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking heart research and improve future diagnostic methods.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this PET-MRI imaging technique is safe?
Research has shown that 11C-Martinostat, the treatment under study in this trial, was safe in earlier studies. It binds selectively and reversibly, allowing the body to handle it well. The treatment also provides clear images without causing harm.
PET-MRI, the imaging technique used in this study, is known for producing clear pictures with less radiation than other methods, enhancing patient safety. Both 11C-Martinostat and PET-MRI have been well-tolerated by patients, with no major side effects reported in past research.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it uses 11C-Martinostat with PET-MRI to explore heart conditions like aortic stenosis and diabetes in a new way. Unlike traditional treatments that focus on symptomatic relief or surgical interventions, 11C-Martinostat allows doctors to visualize histone deacetylase activity in the heart, offering insights into cellular processes. This approach could revolutionize how we understand and treat these conditions by providing a detailed molecular view, potentially leading to more targeted and effective interventions.
What evidence suggests that this trial's treatments could be effective?
Research shows that 11C-Martinostat is a promising tool for PET imaging, which reveals how well certain proteins in the body function. This imaging agent has demonstrated potential in the brain for mapping these proteins, possibly aiding in understanding various diseases. In this trial, participants with aortic stenosis, diabetes, and healthy subjects will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI. For aortic stenosis and diabetes, PET-MRI combines two imaging types to provide detailed pictures of the heart and blood vessels. Although this trial focuses on imaging rather than direct treatment, understanding these interactions could improve the diagnosis and management of heart conditions in the future.26789
Are You a Good Fit for This Trial?
This trial is for healthy adults, individuals with diabetes but no heart issues, and patients with aortic stenosis. Participants must be able to consent and have recent echocardiograms or MRI scans as applicable. It excludes those with medical diseases (for healthy volunteers), left ventricular hypertrophy or heart failure (for diabetics), and other unstated criteria.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging
Participants receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI
Follow-up
Participants are monitored for safety and effectiveness after imaging
What Are the Treatments Tested in This Trial?
Interventions
- 11C-Martinostat
- PET-MRI
Trial Overview
The study tests 11C-Martinostat using PET-MRI imaging to understand its effects on the heart in people with aortic stenosis, those with diabetes, and healthy volunteers. The goal is to see how this radioligand behaves in different states of cardiac health.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Patient subjects with aortic stenosis will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI before and after transcatheter valve replacement.
Patient subjects with diabetes will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI.
Healthy subjects will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Citations
NCT03549559 | Imaging Histone Deacetylase in the Heart
The overall goal of this PET-MR imaging trial is to evaluate 11C-Martinostat, a histone deacetylase targeted radioligand, in patients with aortic stenosis, ...
Kinetic Analysis and Quantification of [11C]Martinostat for in ...
This study demonstrates that [11C]Martinostat is a promising PET imaging agent for the in vivo quantification of class I/IIb HDAC binding in the brain. Results.
3.
bjcardio.co.uk
bjcardio.co.uk/2023/01/what-can-we-do-to-improve-the-diagnosis-and-treatment-of-aortic-stenosis/What can we do to improve the diagnosis and treatment ...
Registry data from 10 centres across Europe and Canada have shown improvement in quality of life at three months following intervention, with ...
4.
massgeneral.trialstoday.org
massgeneral.trialstoday.org/?page=eJyLVspLrShR0lHycw4xMLU0NDM2tlTS0bWEAR1jPUMjY0NLIx1DczMTUxNzIwMQ0FHKSy4xMDazMDM0MlGKBQBGsg_hMass General - Division of Clinical Research
... Martinostat, a histone deacetylase targeted radioligand, in patients with aortic stenosis, individuals with diabetes, and healthy volunteers. ... outcomes ...
Imaging Histone Deacetylase in the Heart - ClinicalTrials.Veeva
Patient subjects with aortic stenosis will receive an IV injection of 11C-Martinostat and undergo simultaneous PET-MRI before and after ...
NCT03549559 | Imaging Histone Deacetylase in the Heart
The overall goal of this PET-MR imaging trial is to evaluate 11C-Martinostat, a histone deacetylase targeted radioligand, in patients with aortic stenosis, ...
7.
massgeneral.trialstoday.org
massgeneral.trialstoday.org/?page=eJyLVspLrShR0lHycw4xMLU0NDM2tlTS0bWEAR1jPUNjA0szIxMdQ3MzE1MTcyMDENBRyksuMTCxMDExMzBTigUAVqgQGg--Mass General - Division of Clinical Research
... Martinostat, a histone deacetylase targeted radioligand, in patients with aortic stenosis, individuals with diabetes, and healthy volunteers. expand. The ...
Global Oxidative Status Is Linked to Calcific Aortic Stenosis
Global oxidative status is linked to calcific aortic stenosis: the differences due to diabetes mellitus and the effects of metformin.
9.
researchgate.net
researchgate.net/publication/265474798_In_Vivo_Imaging_of_Histone_Deacetylases_HDACs_in_the_Central_Nervous_System_and_Major_Peripheral_OrgansIn Vivo Imaging of Histone Deacetylases (HDACs) in the ...
In vivo, [ 11 C]C-martinostat has shown a selective, reversible and dose-dependent binding, excellent signal-to-noise ratio and desirable safety ...
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