Clinical Research Directory

Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)

Structural heart disease (SHD), including valvular heart disease and left ventricular systolic dysfunction, is common in older adults and often goes undetected until symptoms or complications such as heart failure develop. Current detection relies on opportunistic clinical evaluation, including cardiac auscultation, which has limited sensitivity and is inconsistently performed, and echocardiography, which is accurate but resource-intensive. The IMPROVE trial (IMportance of Point-of-caRe ultrasOund for Early Detection of Valvular and Cardiac DiseasEs) evaluates whether an artificial intelligence-guided point-of-care ultrasound (POCUS) screening strategy, embedded in routine primary care and geriatrics ambulatory visits, increases detection of clinically significant SHD compared with usual care. Provider clusters at three health systems will be randomized 1:1 to the AI-POCUS screening strategy or usual care, and approximately 1,440 patients aged 65 years and older will be enrolled over 24 months. In the screening arm, trained clinic staff will acquire cardiac images using an AI-guided handheld ultrasound device; images will be analyzed by FDA-cleared AI software under core laboratory supervision, and patients with a positive screen will be referred to their primary care provider for consideration of a confirmatory transthoracic echocardiogram. The primary outcome is a new diagnosis of SHD (moderate or greater valvular disease, or left ventricular ejection fraction of 50% or less) confirmed by echocardiography within 90 days of the index visit. Secondary outcomes include recall rate, downstream testing and costs, cardiology or cardiac surgery referrals, and major adverse cardiac events over two years. The trial uses a type 1 hybrid effectiveness-implementation design and will concurrently assess the acceptability, feasibility, and determinants of AI-POCUS adoption in ambulatory practice.

Association of Prosthesis Types for Aortic or Mitral Valve Replacement With Long-term Risk of Mental Disorders

Patients were enrolled if the patients aged 60 to 70 years who underwent surgical aortic or mitral valve replacement. The age range was restricted to 60 to 70 years to ensure comparability in surgical indications between prosthesis types. Patients who underwent concomitant coronary artery bypass grafting or aortic surgery were excluded. To construct a cohort at risk for incident mental disorders, we excluded patients with a diagnosis of depression, anxiety disorder , or sleep disorder within one year prior to the index date. These conditions were identified using International Classification of Diseases, Tenth Revision codes recorded in claims data. The exposure of interest was the type of prosthetic valve implanted at the index surgery. Patients were classified into mutually exclusive groups based on the prosthesis type recorded at the index procedure. The primary outcome was incident mental disorder after valve replacement, defined as a composite of depression, and anxiety disorder.

Rivaroxaban vs Warfarin in Patients With Mechanical Heart Valves

Warfarin is the standard anticoagulant used for patients with mechanical heart valves; however, its use is complicated by a narrow therapeutic window, frequent drug and dietary interactions, and the need for regular international normalized ratio (INR) monitoring. In resource-limited settings such as Pakistan, many patients have difficulty accessing reliable INR testing, which can result in suboptimal anticoagulation and increased risks of thromboembolic or bleeding complications. Rivaroxaban, a direct oral factor Xa inhibitor, offers predictable pharmacokinetics and does not require routine laboratory monitoring, making it a potentially more convenient option for patients with limited access to INR testing. This prospective comparative study aims to evaluate rivaroxaban as an alternative to warfarin in patients with mechanical heart valves. Sixty adult patients will be enrolled and followed for one year, comparing the incidence of thromboembolic and bleeding events between patients treated with rivaroxaban and those maintained on dose-adjusted warfarin.

CardioNETPOL National Registry of Carcinoid Heart Disease

Carcinoid tumors are neuroendocrine tumors (NETs), most commonly originating from the gastrointestinal tract, that may secrete bioactive substances such as serotonin. Persistent exposure to these mediators can lead to carcinoid syndrome and, in up to 50% of patients, carcinoid heart disease (CHD). CHD is characterized by fibrotic degeneration of cardiac valves, predominantly right-sided, resulting in progressive valvular dysfunction and a significant increase in mortality. The mechanisms underlying selective cardiac involvement and predictors of disease progression remain incompletely understood. In addition, optimal timing and selection of surgical versus transcatheter valve interventions, particularly in high-risk patients, require further clarification. This multicenter, retrospective observational registry aims to identify and characterize patients with carcinoid heart disease and at least moderate valvular involvement. CHD is defined by confirmed neuroendocrine tumor, echocardiographic evidence of ≥ moderate valvular disease with features of fibrosis, elevated NT-proBNP (\>260 ng/L), and histopathological confirmation when available. Approximately 100-120 consecutive patients will be enrolled over 12 months. Standardized data collection will include detailed echocardiographic assessment, demographic and clinical characteristics, cardiovascular risk factors, comorbidities, tumor features, oncological treatment history, and cardiac management strategies. The primary objective is to describe the clinical profile and management of patients with CHD in a real-world multicenter setting. Secondary objectives include identifying factors associated with advanced valvular dysfunction and evaluating eligibility and outcomes of transcatheter valve therapies. The registry is expected to improve risk stratification and support clinical decision-making in carcinoid heart disease.

The VALVE-AI Trial

The goal of this clinical trial is to learn if an artificial intelligence-powered electrocardiogram (AI-ECG) can help detect moderate or severe valvular heart diseases (VHD) in adults. The main question it aims to answer is: ．Can AI-ECG screening identify patients with significant heart valve diseases who may benefit from early echocardiography? Researchers will compare the rate of moderate or severe VHD detection between the experimental group and the control group to see if AI-ECG improve the detection rate of significant VHD. Participants will: * Be classified as high- or low-risk for VHD using an AI-ECG system * In the experimental group, high-risk participants will receive echocardiography based on AI-ECG results * In the control group, usual clinical care will be provided without routine echocardiography for AI-ECG high-risk results.