Aortic Disease

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 predictive tool called the Multifactorial Dynamic Perfusion Index MDPI to estimate the risk of acute kidney injury after cardiac surgery involving cardiopulmonary bypass CPB. This observational study involves adults and infants undergoing cardiac surgery, aiming to validate the MDPI in adults, develop a version for infants under 20 kg, and explore if the MDPI can predict other complications including mortality. The MDPI combines seven variables measured during CPB, many of which can be modified by the surgical team to potentially improve patient outcomes. The study is divided into three parts first, validating the MDPI in 800 adult cardiac surgery patients from two centers using existing CPB monitors that collect data such as hematocrit, oxygen delivery, arterial pressure, and transfusions second, developing a modified MDPI for 200 infants under 20 kg undergoing congenital heart surgery with additional infant-specific variables and third, investigating whether the MDPI can predict other postoperative issues like low cardiac output, longer ICU stays, bleeding complications, and 30-day mortality. Data collection includes parameters recorded during surgery and postoperative creatinine values. Participants will undergo cardiac surgery with CPB, during which relevant physiological data will be continuously recorded by specialized monitors. After surgery, kidney function and other outcomes will be monitored for up to 48 hours, with extended follow-up for complications and mortality over 30 days. Researchers will analyze how well the MDPI predicts acute kidney injury and other clinical outcomes, aiming to incorporate the MDPI into real-time monitoring devices to guide therapeutic decisions during surgery.

Researchers are conducting a multi-center clinical study to assess artificial intelligence AI algorithms for measuring heart function and size using echocardiography. The study aims to compare AI measurements with those of physicians at different experience levels, evaluate the accuracy and stability of AI, and explore its use in complex heart conditions like cardiomyopathy, valve disease, and coronary heart disease. The goal is to improve diagnostic consistency and clinical workflows across medical centers. The study involves measuring cardiac chamber size and function in 1600 participants using AI, senior physicians, and intermediate physicians. All measurements are made with Mindray ultrasonic machines. AI and intermediate physician results are completed within one day after data collection, while senior physician results are completed within one month. The study will establish a standardized reference system for AI-assisted echocardiographic measurements and evaluate AIs performance in special cases. Participants will undergo echocardiographic scans with measurements of left and right ventricular size and function, Doppler ultrasound indicators, and valve annulus displacements. Researchers will analyze data to compare AI and physician measurements, assess measurement deviations, and evaluate AIs efficiency in reducing analysis time. The study will run until July 2026, with ongoing data collection and analysis across multiple centers, aiming to promote wider clinical application of AI technology for cardiovascular disease diagnosis.

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 use of dapagliflozin to reduce cardiovascular risk in women who have experienced hypertensive pregnancies. This randomized, placebo-controlled trial focuses on patients at high risk for adverse cardiovascular outcomes within five years after delivery. The study is a pilot-scale, single institution investigation aiming to assess the feasibility, acceptability, and effects of dapagliflozin during the postpartum period. Participants will be randomly assigned to one of two groups one group will receive dapagliflozin 10 mg daily for six months, while the other group will receive a daily placebo for the same duration. During the study, participants will attend four study visits and complete specific activities including daily blood pressure monitoring, weekly weight measurements, laboratory tests, and echocardiograms. After the six-month treatment period, participants will be followed remotely for one month. Throughout the trial, researchers will measure cardiovascular risk reduction scores at the start and after six months of treatment. Secondary outcomes include tracking patient adherence, barriers to adherence, loss to follow-up rates, and screening statistics over a two-year recruitment period. The total participation includes treatment and follow-up visits, with regular assessments to monitor health and gather data for evaluating the study drugs impact on cardiovascular risk.

Researchers are investigating congenital bicuspid aortic valve BAV, a heart condition that may be more common in China than previously recognized. This observational study aims to analyze gene backgrounds, disease progression, and imaging features of young people with BAV, along with their long-term health outcomes. The study hopes to identify individuals at higher risk based on specific gene expression or other clinical characteristics. The study follows a cohort of participants aged 14 to 60 years who have a confirmed diagnosis of BAV through imaging methods such as echocardiography or cardiac magnetic resonance. Participants will be observed over time without receiving experimental treatments. The study will monitor disease progression, including the need for surgical aortic valve replacement SAVR or transcatheter aortic valve replacement TAVR over a five-year period. Participants will undergo regular follow-up visits to assess heart health and disease status using imaging and clinical evaluations. The study will track major adverse cardiovascular events MACE during the five years. Researchers will collect data on patient outcomes, disease progression, and treatment interventions. The total participation duration extends across several years to capture long-term follow-up information.

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.