Medford

Researchers are investigating factors that might predict serious heart problems, such as sudden death caused by fast heart rhythms or heart failure, in people with hypertrophic cardiomyopathy (HCM), a genetic condition where the heart muscle thickens and may become stiff or disrupt the heart's electrical system. This study focuses on patients who previously took part in the HCMR research project, which examined the presence of a substance called gadolinium in heart muscle, known as late gadolinium enhancement (LGE). The study aims to better understand how LGE relates to heart risks in HCM patients. This is an observational study that involves no new treatments or interventions. It will include follow-up imaging of patients from the original HCMR cohort to monitor changes in LGE over time. The study specifically looks at patients with obstructive or non-obstructive HCM, with specific criteria related to heart function, body mass index, and blood markers. There are no experimental drugs or devices used; participants undergo imaging and clinical evaluations. Participants will be followed over a minimum of seven years to track changes in the percentage of LGE mass in their hearts from baseline. During this time, researchers will collect imaging data and monitor heart function and outcomes. The long-term follow-up aims to provide insights into how LGE affects health risks in HCM. Throughout the study, safety and heart health will be closely monitored, and no treatments are administered as part of this observational research.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.