Aneurysm

Researchers are working to create and use a comprehensive database focused on intracranial aneurysms (IA). This project collects and studies clinical history, imaging data, biological samples, and other information to understand factors linked to the formation and rupture of aneurysms. They aim to identify genetic, environmental, and anatomical markers, as well as evaluate outcomes from different treatment strategies and improve patient care protocols. Participants include patients with diagnosed aneurysms, both ruptured and unruptured, family members of affected individuals, and healthy volunteers. Data collected involves detailed clinical records, imaging scans like MRI angiography and CT angiography, and various biological samples such as blood, cerebrospinal fluid, saliva, and stool. Consent covers access to medical records, use of biological samples, and potential future research uses including genetic analyses. During the study, participants provide health and lifestyle information, imaging data, and biological samples. Researchers will monitor multiple long-term outcomes including disease progression, life expectancy, quality of life, neurological and cognitive status, and treatment effects over periods up to 20 years. Data confidentiality is maintained, and participants can withdraw at any time without affecting their medical care. The study aims to validate disease models and support advances in aneurysm management and research.

Researchers are studying the quality of life in adults with hypertrophic cardiomyopathy (HCM), thoracic aortic dilatation (TAD), and radiation-induced heart disease (RIHD) who are not suitable candidates for surgery. This observational study aims to understand how these heart conditions affect patients' daily lives and well-being. The research seeks to identify risk factors linked to lower quality of life and changes over time to improve long-term management. Participants are adults diagnosed with HCM, TAD, or RIHD who are visiting the Cleveland Clinic for the first time for cardiac evaluation without prior or planned surgery. They will complete the Cardiac Quality of Life (QOL) Survey electronically at three points: baseline, 3 months, and 9 months. The survey covers five areas—global, physical, emotional, social, and spiritual health—and measures self-efficacy and resilience. During the study, participants will provide information through these surveys to help assess their health status across multiple domains. Researchers will compare results at 3 and 9 months to baseline to understand changes in quality of life and the impact of heritability and radiation-induced disease. The total participation time is about nine months, with ongoing monitoring through outpatient clinic visits and electronic questionnaires.

Researchers are evaluating a new imaging method using ferumoxytol-enhanced cardiac magnetic resonance imaging (MRI) to detect blood clots inside the heart in patients with ventricular aneurysm or those who have undergone percutaneous ventricular reconstruction. The study aims to compare this new MRI approach with the commonly used transthoracic echocardiography, which has lower accuracy in detecting these clots. Ferumoxytol is an iron-based contrast agent that may offer safer and more effective imaging, especially for patients with kidney problems. Participants will receive the ferumoxytol-enhanced cardiac MRI along with a transthoracic echocardiography for comparison. The ferumoxytol contrast agent has a long blood circulation time, allowing for detailed and repeated MRI scans. This observational study is non-randomized and includes patients with ventricular aneurysm or those about 180 days after percutaneous ventricular reconstruction. Experts will review imaging results independently to evaluate detection rates. During the study, participants will undergo imaging tests to detect intracardiac thrombus and assess thrombus presence in both dynamic and static heart chambers. Researchers will measure the detection rates of clots from November 2023 to March 2025. The study includes monitoring for safety and tolerability related to the contrast agent. Participants will be involved in scheduled imaging and clinical assessments over the study period.

Researchers are evaluating the safety and performance of the Choydar Flow-Directed Mesh Stent in treating unruptured intracranial aneurysms, which are bulging blood vessels in the brain that have not ruptured. This observational study aims to gather real-world data on how well this stent works in patients with these aneurysms, focusing on treating wide-neck saccular or fusiform aneurysms in specific brain arteries. The study involves using the Choydar Flow-Directed Mesh Stent according to its official instructions in participants who have unruptured aneurysms in the internal carotid or vertebral arteries. Only this stent will be used for treatment, and no other interventions are part of the study. The stent is placed during a procedure guided by imaging techniques to treat the aneurysm. Participants will be monitored through follow-up visits over 12 months after the procedure. Researchers will assess outcomes such as the rate of complete and adequate aneurysm closure, technical success at the time of the procedure, need for additional treatments, functional status using a modified scale, and any major complications or vessel narrowing. The study tracks safety events during the procedure and throughout the year to understand long-term effects. Participants must be able to return for all follow-up visits as required.

Researchers are studying patients with unruptured intracranial aneurysms to understand the relationship between cotinine levels and aneurysm wall enhancement seen on high-resolution magnetic resonance imaging (HRMRI). This observational study aims to explore how these imaging features and cotinine levels might relate to the risk of aneurysm rupture and patient outcomes. The research includes following patients' prognosis and aneurysm occlusion rates to better understand this connection. Participants undergo high-resolution magnetic resonance angiography to detect and classify the presence or absence of aneurysm wall enhancement. Blood or urine samples are collected for cotinine testing, which relates to smoking exposure. Patients are grouped based on whether their aneurysm wall shows enhancement on HRMRI. The study follows patients for at least one year to observe imaging features, functional outcomes measured by the modified Rankin Scale (mRS), and aneurysm occlusion rates. During the study, participants will have imaging and clinical assessments at baseline and follow-up visits according to the research protocol. Researchers will monitor aneurysm features on HRMRI, patient functional status at 12 months, and aneurysm occlusion status after treatment. Participants will also provide samples for cotinine analysis. The study is expected to last until March 2027, with ongoing follow-up to evaluate correlations between imaging findings, cotinine levels, and patient outcomes.

Researchers are evaluating KLN-1010, a novel gene therapy, in patients with relapsed or refractory multiple myeloma to assess its safety, tolerability, and to determine the recommended Phase 2 dose. The trial is a Phase 1 study sponsored by Kelonia Therapeutics, Inc., focusing on patients who have previously undergone multiple treatments for their condition. Participants receive a single specified dose of KLN-1010, which is designed to generate anti-B Cell Maturation Antigen (anti-BCMA) CAR-T cells in the body. This gene therapy is administered once during the study, and its effects, including safety and pharmacokinetics, are closely monitored over time. During the study, participants undergo assessments for treatment-emergent adverse events and dose-limiting toxicities for up to 15 years after dosing. Pharmacokinetic evaluations of KLN-1010 and generated CAR-T cells occur up to two years post-infusion. Multiple myeloma status is monitored from dosing until disease progression or up to 15 years, with comprehensive safety and disease assessments throughout the follow-up period.

Researchers are studying the safety and effectiveness of the Rapidlink device in patients who need repair or replacement of the supra-aortic vessels during open surgery for thoracic aortic disease. This includes conditions affecting the aortic arch, where traditional surgery can be challenging. The study aims to simplify and speed up the connection of grafts to these vessels using the Rapidlink device, which may reduce the need for extra surgical steps. The Rapidlink device consists of a Gelweave graft attached to a stented section with nitinol rings, delivered via a single-use system. The study includes two groups: up to 120 patients undergoing elective surgery and up to 30 patients undergoing emergency surgery. Initially, the first 32 elective patients will receive the device for left subclavian artery repair only. After that, enrollment will expand to include repair of any supra-aortic vessel in elective cases. Emergency cases will be enrolled after the first 32 elective cases. Participants will be evaluated before surgery, during the implant, at hospital discharge or 30 days, and at 3, 6, 12, and 24 months after surgery. Researchers will monitor major adverse events at 6 months, technical and clinical success of the device, rates of stroke, vessel rupture, device-related complications, and other clinical outcomes. Data collection includes assessments during hospital recovery and follow-up visits for up to 2 years.

Researchers are evaluating the potential of a new technique called Brillouin microscopy to diagnose corneal conditions such as keratoconus and ectasia. The study compares the biomechanical properties of corneas in people with keratoconus, those with post-LASIK ectasia, and individuals with normal corneas. This observational study aims to better understand differences in corneal tissue using this advanced imaging method. Participants include volunteers with normal corneas, patients diagnosed with various stages of keratoconus, individuals who had LASIK surgery with or without complications, people scheduled for PRK or LASIK surgery, and patients with Fuch's endothelial corneal dystrophy. The study involves axial scans of the cornea using Brillouin imaging to assess and compare corneal biomechanics across these groups. Specific inclusion and exclusion criteria apply to each group based on diagnosis, prior surgeries, and other eye health factors. During the study, participants undergo corneal imaging to measure the cornea's elastic modulus, reflecting its biomechanical properties. Researchers monitor these properties over time to evaluate the diagnostic capabilities of Brillouin microscopy. Participants will be assessed for corneal health through topography, pachymetry, and clinical evaluations, with the study lasting several years to gather comprehensive data. The research team also excludes individuals unable to understand imaging instructions or with certain eye conditions to ensure accurate measurements.

Researchers are conducting a prospective, multicenter, randomized trial to assess the effectiveness and safety of the Sperstent® peripheral spot stent system compared to the Everflex® self-expanding peripheral stent system. The study focuses on treating residual lesions such as stenoses and dissections that remain after balloon angioplasty in the femoral and proximal popliteal arteries. These conditions are common in patients with peripheral arterial disease and affect blood flow in the legs. Participants will receive either the Sperstent® peripheral spot stent system or the Everflex® self-expanding peripheral stent system during endovascular treatment following percutaneous transluminal angioplasty (PTA). Both treatments involve placing a stent to open narrowed or blocked arteries, guided by digital subtraction angiography (DSA). The trial compares these two devices to understand their impact on artery patency and safety over time. Throughout the study, participants will be closely monitored with follow-up assessments including imaging to check artery openness, clinical evaluations of symptoms using Rutherford classification and ankle-brachial index (ABI), and tracking of major adverse events. Key outcomes include primary patency at 12 months and freedom from major adverse events at 30 days after the procedure. The study period includes evaluations immediately after treatment and at 30 days, 6 months, and 12 months to monitor device success, procedural success, and changes in clinical status.

Abdominal aortic aneurysm (AAA) is a serious vascular condition involving the enlargement of the abdominal aorta, which can lead to rupture and life-threatening bleeding. Because AAA often shows no symptoms until rupture, early detection and accurate monitoring are essential. This research focuses on evaluating computed tomography angiography (CTA) as a key imaging method to improve diagnosis and risk assessment for AAA. The study collects CTA imaging results from patients with AAA seen in inpatient, emergency, and outpatient settings at the study hospital. CTA provides detailed images of the aneurysm's size, wall thickness, thrombus presence, and relation to nearby structures. These details are important for making decisions about when to intervene and how to manage the condition. Participants will have their maximal abdominal aortic diameter measured using CTA within one month, along with tracking of rupture events, mortality, and other aneurysm characteristics. The study gathers important clinical data to help refine AAA screening and treatment timing. Participation involves undergoing CTA scans and data collection, with the aim to develop better assessment standards and personalized care for AAA patients.