Microarrays for Heart Transplantation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method for caring for heart transplant recipients. The focus is on the Molecular Microscope Diagnostic System, which aids doctors in assessing the new heart's condition. The goal is to determine if this system should become a standard part of transplant patient care. Candidates may qualify if they have had a heart transplant and their doctor has recommended a biopsy to evaluate the heart. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to advancements in innovative care.
Do I have to stop taking my current medications for this trial?
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 the Molecular Microscope Diagnostic System is safe for heart transplant patients?
Research shows that the Molecular Microscope Diagnostic System (MMDx) is a promising tool for heart transplant patients. Studies have found that it provides reliable results, aiding doctors in making more confident diagnoses. It proves especially useful when traditional biopsy results are unclear.
Regarding safety, the MMDx has been used with both kidney and heart transplant patients, and no major safety concerns have been reported. The system analyzes gene activity (how genes are turned on or off) in biopsy samples, focusing on interpreting existing data rather than introducing new drugs into the body.
While specific safety data from these sources is not available, its use in clinical settings for other organs, like kidneys, suggests general safety. However, discussing any concerns with a doctor is important to determine if this is the right option.12345Why are researchers excited about this trial?
Most treatments for monitoring heart transplant health rely on invasive biopsies to assess rejection risk. But the Molecular Microscope Diagnostic System (MMDx) works differently, using gene expression profiling to analyze tissue samples non-invasively. This innovative approach allows for a more precise and less intrusive way to detect organ rejection early on. Researchers are excited about MMDx because it offers potentially faster and more accurate rejection diagnosis, which could lead to better overall transplant outcomes.
What evidence suggests that the Molecular Microscope Diagnostic System is effective for heart transplant patients?
Research has shown that the Molecular Microscope Diagnostic System (MMDx) can aid in diagnosing heart transplant patients. One study found that MMDx detected signs of transplant rejection in 42% of cases, compared to 11% with traditional methods. This suggests that MMDx might identify issues that other tests miss. The system analyzes genes to detect signs of rejection, potentially making it a more accurate tool. However, experts indicate that further research is necessary to confirm its effectiveness. Despite this, the promising results could improve care for heart transplant patients.678910
Who Is on the Research Team?
Philip F Halloran, MD PhD
Principal Investigator
University of Alberta
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Diagnostic Development
Development of a Reference Set of EMB and adaptation of the MMDx system to assess and report EMBs
Validation and Refinement
Validation and refinement of the MMDx system in 900 unselected prospectively collected EMBs
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Molecular Microscope Diagnostic System
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor
Citations
The Molecular Diagnosis Might Be Clinically Useful in ...
The Molecular Microscope Diagnostic System (MMDx) may overcome histology shortcomings. Previous studies have simply examined discrepant findings but have ...
The molecular microscope diagnostic system (MMDx) in ...
In summary, the MMDx system is a promising approach in need of more rigorous validation. There are no objective data that establish its superiority over ...
3.
portlandpress.com
portlandpress.com/clinsci/article/138/11/663/234525/Precision-diagnostics-in-transplanted-organs-usingPrecision diagnostics in transplanted organs using microarray ...
This review outlines the development and refinement of the Molecular Microscope® Diagnostic System (MMDx) technology using genome-wide ...
Clinical Utility of Molecular Microscope Diagnostic System ...
70 samples were positive by MMDx (42%) whereas by histology only 18 (11%) were positive. Median dd-cfDNA levels in the (+) MMDx group were 0.58% (IQR 0.30-1.25 ...
Evolving the surveillance and workup of heart transplant ...
MMDx results are reported as no rejection, TCMR, AMR, or mixed rejection if both TCMR and AMR were detected. Injury on MMDx was defined in patients without ...
6.
thermofisher.com
thermofisher.com/us/en/home/clinical/transplant-solutions/lab-services/molecular-biopsy-assessment.htmlMMDx for Molecular Biopsy Assessment
MMDx complements conventional histopathology by providing reproducible results, enhancing diagnostic confidence. Actionable data: Measures the probability of ...
Molecular Microscope Diagnostic System in Patients after ...
MMDx examination is suitable for complementing patients with ambiguous histological findings and a clinical picture not corresponding to biopsy results.
IKEM MMDx - Molecular Microscope® Diagnostic System
Molecular Microscope Diagnostic System (MMDx) measures gene expression in biopsy samples of kidney and heart transplant patients.
9.
medtechspectrum.com
medtechspectrum.com/news/64/24894/thermo-fisher-scientific-introduces-molecular-microscope-diagnostic-system.htmlThermo Fisher Scientific Introduces Molecular Microscope ...
Thermo Fisher's new Molecular Microscope® Diagnostic System for Lung (MMDx® Lung) leverages the power of machine learning to profile gene ...
Molecular Genetics Safety Data Sheet (SDS)
Biosafety Level 2 precautions at a minimum should be used in laboratory settings. Physical and Chemical Properties. Medical Glass microscope slides of human ...
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