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 areasglobal, physical, emotional, social, and spiritual healthand 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 burst. This observational study is conducted in a real-world setting to observe how well the device works without additional interventions. The study is sponsored by Johnson & Johnson Medical Shanghai Ltd. and focuses on participants with specific aneurysm types and sizes in certain brain arteries. Participants will receive the Choydar flow-directed mesh stent according to its approved instructions. No other treatments are part of this study. The procedure targets wide-neck saccular or fusiform aneurysms in the internal carotid or vertebral arteries, with parent artery diameters between 2.0 and 6.0 millimeters. The study observes participants through a 12-month follow-up period after the procedure to assess success and safety. During the study, participants will be assessed at several points including the day of the procedure and at 12 months afterward. Researchers will monitor outcomes such as aneurysm occlusion rates, technical success of the procedure, re-treatment rates, functional neurological status, and any major ischemic, hemorrhagic events, or deaths. The study involves imaging and clinical evaluations to measure these outcomes and ensure participant safety throughout the follow-up period.

Ascending aortic aneurysms AAAs are serious conditions that can cause life-threatening aortic dissections or ruptures. The progression and severity of these aneurysms are influenced by the type of aortic valve a patient hasbicuspid or tricuspid. This study aims to compare inflammatory, metabolic, and gene expression patterns in myeloid cells and aortic tissue between patients with bicuspid and tricuspid aortic valves to better understand underlying molecular mechanisms and identify potential biomarkers or treatment targets. Patients with aneurysms caused by genetic syndromes are not included to keep the study group uniform. Participants with ascending aortic aneurysms undergoing scheduled surgical replacement will be grouped based on whether they have a bicuspid or tricuspid aortic valve. During surgery, samples of the aneurysmal aortic tissue, which would otherwise be discarded, are collected for research. Additionally, extra blood samples are taken during routine clinical blood draws for further analysis. The surgical procedure is not altered by the study. Throughout the study, participants undergo preoperative ultrasound imaging to confirm valve type. Researchers analyze inflammatory, metabolic, and transcriptomic markers in both the collected myeloid cells and aortic tissue at the time of surgery. Consent is required before participation. The study is observational and will continue until August 2029, focusing on understanding disease mechanisms rather than testing treatments.

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 the safety, tolerability, and best dose for Phase 2 of KLN-1010, a new gene therapy, in patients with relapsed or refractory multiple myeloma. This treatment aims to generate anti-B cell maturation antigen Anti-BCMA CAR-T cells directly in the body to target cancer cells. The trial is a Phase 1 study sponsored by Kelonia Therapeutics, Inc. and focuses on patients who have received multiple prior therapies. Participants receive a single specified dose of KLN-1010 during the treatment phase. The study follows them for up to 15 years after dosing to monitor safety and establish the recommended dose for future testing. Pharmacokinetics, including how the drug and CAR-T cells behave in the body, are assessed for up to two years. Disease status is also tracked from dosing until progression or for up to 15 years. Throughout the study, participants undergo regular evaluations including safety assessments for adverse events and dose-limiting toxicities. Laboratory tests and clinical assessments measure how the therapy affects the disease and the participants health. Long-term monitoring ensures ongoing safety and effectiveness measurements, with the entire participation lasting up to 15 years after treatment.

Researchers are evaluating the safety and effectiveness of the Rapidlink device in patients undergoing open surgical repair of the thoracic aorta involving the supra-aortic vessels, such as the left subclavian artery, left common carotid artery, and innominate artery. The study addresses challenges in repairing these vessels during surgery, aiming to simplify and speed up the process while reducing the need for additional procedures. This is an interventional study sponsored by Vascutek Ltd. focusing on patients with aortic disease requiring vessel repair or replacement. Participants will have the Rapidlink device implanted in one or more of the supra-aortic vessels during their planned or emergency open thoracic aorta surgery. The device consists of a graft section attached to a stented section, designed to be placed with minimal sutures and manipulation. The study first enrolls 32 patients undergoing left subclavian artery repair or replacement, then expands to include other supra-aortic vessel repairs. Up to 30 additional patients will be enrolled in an emergency setting after the initial group. Participants are evaluated before, during, and after surgery, with follow-up visits at discharge, 30 days, 3 months, 6 months, 12 months, and 24 months. Evaluations include safety and clinical success measures, occurrence of adverse events such as stroke or vessel rupture, device integrity, and need for secondary interventions. The primary outcome is the absence of major adverse events six months after the procedure. Data collection involves clinical assessments and monitoring to understand the devices performance and safety over two 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 Fuchs 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 corneas 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.