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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are investigating factors that may predict heart problems, such as sudden death from fast heart rhythms or heart failure, in people with hypertrophic cardiomyopathy HCM. This genetic condition causes the heart muscle to thicken, which can make the heart stiff and affect its electrical system. The study aims to follow up on patients previously involved in a research project called HCMR - Novel Predictors of Outcome in Hypertrophic Cardiomyopathy to better understand the role of late gadolinium enhancement LGE, a substance collected in heart muscle that may indicate higher risk for heart complications. This observational study will involve patients from the original HCMR cohort, divided into groups with obstructive and non-obstructive HCM based on specific heart measurements. The study will use follow-up imaging to assess changes in LGE over a minimum of seven years. No new treatments are given instead, the study observes how the condition progresses and how LGE is related to heart problems. Participants will undergo regular imaging assessments to track changes in the percentage of LGE mass in their heart muscle compared to baseline measurements. The research team will monitor heart function and symptoms over time. The study will last several years, providing valuable information about the progression of HCM and the risks associated with LGE in affected individuals.

Age: 18Years - 65YearsAll Genders
8 locations
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Actively Recruiting

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Age: 18Years +All Genders
2368 locations