Clinical Research Directory

A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)

Kosmos PLAX EF Pivotal Study

The purpose of this study is to validate the efficacy of Kosmos PLAX EF, an AI-assisted workflow that uses a cardiac ultrasound clip in Parasternal Long Axis (PLAX) cardiac view to calculate Left Ventricular Ejection Fraction (LVEF) using the Teichholz method. This study will compare the algorithm-generated measurements to measurements performed by hand by expert echocardiographers. The primary objectives of the study are to demonstrate that the algorithm measurements are statistically interchangeable with measurements from a reference standard derived from human expert readers. The primary hypotheses are that the algorithm measurements of left ventricular internal dimensions at 1) end-diastole (LVIDd) and 2) end-systole (LVIDs), respectively, will be statistically non-inferior to the reference standard. The secondary objective is to demonstrate that the algorithm-calculated LVEF is statistically interchangeable with the LVEF calculated by human readers. The secondary hypothesis is that the LVEF calculated from algorithm measurements will be statistically non-inferior to the reference standard. The study design involves the compilation of de-identified, retrospective PLAX-view clips acquired using the Kosmos diagnostic ultrasound system. This data was collected from two previous studies, and was not used in the training of the PLAX EF AI algorithm, or in the ECHO-300 PLAX EF pilot study.

Kosmos Guidance Performance Evaluation Data Annotation

The purpose of this study is to supplement prior Kosmos Trio Guidance performance testing conducted under ECHO-020 Kosmos Guidance, Grading, and Capture Performance Evaluation Protocol. The Kosmos Trio Guidance algorithm is designed to provide guidance to help novice scanners acquire images and videos during ultrasound scanning of three cardiac views (Parastenal Long Axis, Apical 4 Chamber, and Apical 2 Chamber) with Kosmos Trio. The study will divide the guidance cues not evaluated sufficiently in the ECHO-020 study into four categories: 1) corrective guidance, 2) incorrect scanning window, 3) incorrect probe orientation, and 4) low confidence prediction. For each guidance cue evaluated in this study, expert annotators will review two clips: one suboptimal view, collected when the probe is positioned at an incorrect location; and one guided view, captured after the sonographer followed the probe motion cue displayed by the system. Annotators will review each pair of clips and respond indicating either i) Yes, the guided clip demonstrates the appropriate correction from the suboptimal view; ii) No, the guided clip does not demonstrate the appropriate correction from the suboptimal view; or iii) Unevaluable, the guided clip is technically inadequate for assessment. For each category of guidance cues, the outcome measure will be the rate at which annotators respond "Yes." Finally, this study will also evaluate the Kosmos Trio Auto-Capture algorithm's ability to detect and capture a diagnostic-quality image. Annotators will rate clips captured by Kosmos Trio Auto-Capture on an ACEP-based image quality scale. The outcome measure will be the image quality score. The study design involves the compilation of de-identified retrospective cardiac clips acquired using the Kosmos diagnostic ultrasound system. This data was collected for two previous studies; no additional data will be collected from previous study participants for the purposes of this study.

Kinesthetic Exercises on Adults

The aim of this study is to determine the possible effect of kinesthetic brain exercises on cognitive function in patients with heart failure. The study will include 40 volunteer individuals aged 30-65 years who have been diagnosed with heart failure in the Cardiology Department and are followed up with a physiotherapy program. Individuals will be randomized into a kinesthetic brain exercise program group (n=20) and a control group (n=20). The control group will receive routine medication monitoring as well as a routine physiotherapy program. The education group will receive routine medication monitoring and a routine physiotherapy program, in addition to individual kinesthetic brain exercise training. Kinesthetic brain exercises will be performed for 30 minutes, 2 days a week for 8 weeks. Demographic information of the individuals will be collected; age, gender, body mass index, age at diagnosis, ejection fraction ratio, family history, smoking status (years/pack). Cognitive function; The Montreal Cognitive Assessment Scale (MoCA), quality of life using the Minnesota Heart Failure Living Questionnaire, and cognitive performance using the Standardized Minimental Test (SMMT) will be used for evaluation. Biochemical analyses will be performed using the Brain-Derived Neurotrophic Factor (BDNF) ELISA kit. Patients in both groups will be evaluated by a physiotherapist before the study and at week 8.

Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

TRICS-IV is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in moderate to high risk patients who are 65 years of age or younger undergoing cardiac surgery on cardiopulmonary bypass, using a superiority trial design.