Clinical Research Directory

Safe and Explainable AI

While current AI technology is suitable for automating some repetitive clinical tasks, technical challenges remain in solving critical and gainful problems in the domains of patient and disease management. The proposed research seeks to address issues in medical AI, such as integrating medical knowledge effectively, making AI recommendations explainable to clinicians, and establishing safety guarantees.

Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient

High risk of bleeding (HBR) is a determining factor for the duration of dual antiplatelet therapy (DAPT). Recent studies have shown that the use of one-month DAPT is beneficial in terms of ischemic as well as hemorrhagic events, particularly in HBR patients, compared with longer DAPT. European guidelines therefore authorize one-month DAPT in HBR patients presenting even an acute coronary syndrome. The HT Supreme Drug Coated Coronary Stent System (HT Supreme DES) is designed to promote reendothelialization as quickly as possible. That's why the stent is called "HT" Supreme, with "HT" standing for "Healing Targeted", enabling a DAPT of just 1 month in all-comers HBR patients. Thanks to these features, the investigators aim to demonstrate ischemic and hemorrhagic complication rates lower than those found in the literature with other stent.

High-Sensitivity Troponin I in Addition to Guideline-Based Care in EMS

The TIGER study is a study investigating the utlility of a point-of-care blood analyse of Troponin I to help identify patients with heart attacks in the prehospital emergency care. The study is conducted within the ambulance services of Region Stockholm and compares standard medical care with and without the addition of this quick test. Chest pain is one of the most common reasons for ambulance dispatch, but currently only about one-third of heart attacks are detected before arriving at the hospital-mainly through ECG. The remaining two-thirds are not identified until after further testing at the emergency department. The TIGER study aims to improve early diagnosis by using a high-sensitivity, point-of-care Troponin I test already in the prehospital phase. The study is a randomized controlled trial, where participants are randomly assigned to one of two groups. One group receives standard emergency care along with the rapid Troponin I test in the ambulance. The other group receives standard care without the test. The goal is to evaluate whether the use of Troponin I testing leads to faster and more accurate identification of heart attacks, ultimately improving patient outcomes. In total, about 1,419 adult patients with chest pain or suspected heart attack will participate. The primary outcome being measured is the time from first medical contact to PCI (balloon angioplasty). Secondary outcomes include time spent in different parts of care, hospital length of stay, the occurrence of serious events (such as heart attack, stroke, or death), and the diagnostic accuracy of the test. The study has been approved by the Swedish Ethical Review Authority and includes safety monitoring through an interim analysis after the first 150 patients. Test results from the Troponin I analysis are clearly marked as part of the research study and should be interpreted by the responsible physician alongside other clinical findings.

Large Language Models To Improve the Quality of Care of Cardiology Patients

This study evaluates the impact of large language models (LLMs) versus traditional decision support tools on clinical decision-making in cardiology. General cardiologists will be randomized to manage real patient cases from a cardiovascular genetic cardiomyopathy clinic, with or without AI assistance. Each case will be assessed by two cardiologists, and their responses will be graded by blinded subspecialty experts using a standardized evaluation rubric.

Utility of Gene Test Analysis for Diagnosis, Prognosis and Treatment of Patients With Genetic Arrhythmic Heart Disease: the ARRHYTHMIC GENE-HEART

The goal of this observational study is to enroll all patients evaluated at the specialized Cardiogenetic Center within the Cardiology Department of the University of Ferrara, Italy. The primary aim of the registry is to collect comprehensive clinical, genetic, and electrophysiological data from individuals with suspected or confirmed arrhythmogenic conditions. By systematically documenting patient demographics, family history, clinical presentations, diagnostic findings, and treatment outcomes, the registry seeks to enhance our understanding of the genetic basis and clinical implications of genetically driven arrhythmias and systemic syndromes. This registry will facilitate long-term follow-up of enrolled patients to assess the natural history of arrhythmogenic disorders and the effectiveness of various therapeutic interventions. Additionally, it aims to identify potential risk factors associated with adverse outcomes, such as sudden cardiac death or major arrhythmic events.

Telerehabilitation in Hemodialysis Patients.

Chronic kidney disease is the third most common cause of death, with a prevalence of 10-12%. Patients undergoing hemodialysis often exhibit low levels of physical activity, leading to various health issues, including poor quality of life, fatigue, psychiatric disorders, cardiovascular diseases, musculoskeletal symptoms, and increased mortality. Increased physical activity in this population has been associated with improvements in these health conditions. Walking, for instance, has been linked to a 33% reduction in mortality and a 21% decrease in the need for kidney transplantation. However, recent findings indicate that the average step count among hemodialysis patients is significantly lower compared to the healthy population. Telerehabilitation, utilizing digital innovations such as smartphones and smartwatches, is considered a promising strategy to promote physical activity. This randomized crossover study aims to investigate whether telerehabilitation, combined with a structured feedback intervention via a wearable activity tracker, can increase physical activity in hemodialysis patients. The study seeks to address the limited knowledge on the effectiveness of digital interventions in this population. The hypothesis is that such an intervention could positively influence physical activity levels in this group. The primary objectives of this study are to increase the average step count, improve dialysis parameters, enhance quality of life, improve digital health literacy, increase exercise capacity, reduce overall and cardiovascular mortality, and decrease unplanned hospitalizations in cardiology, nephrology, or geriatrics departments. The study will be conducted at the dialysis center of Jessa Hospital in Hasselt, Belgium, and will include 46 patients. Each participant will consecutively undergo two different types of interventions: telerehabilitation combined with usual care rehabilitation and usual care rehabilitation only. Following recruitment, participants will be randomly assigned to one of two pre-specified intervention sequences: telerehabilitation plus usual care rehabilitation followed by usual care rehabilitation only, or usual care rehabilitation followed by telerehabilitation plus usual care rehabilitation. The study duration will be six months, with each phase lasting three months. Outcome evaluations will be conducted at three time points: baseline assessment, assessment after the first intervention, and assessment after the second intervention. The primary outcome is the daily step count, measured by a Fitbit® Charge 5 tracker. Secondary outcomes include physical function (measured by the Short Physical Performance Battery, Two-Minute Walking Test, Cardiopulmonary Exercise Testing, Hand Grip Strength, reduction of sedentary behavior, and body composition monitoring), blood parameters, dialysis parameters, and quality of life.

Efficacy and Safety of SPC1001 in Patients With Essential Hypertension

\- Objective: This study aims to evaluate the safety and efficacy of the fixed-dose triple combination therapy (SPC1001) of candesartan, amlodipine, and indapamide in adult patients with essential hypertension compared to dual-component therapies of each ingredient for 8 weeks. Additionally, it seeks to confirm the contribution of each component at low doses. \- Inclusion Criteria: Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria. \- Exclusion Criteria: Patients whose blood pressure measured at the screening and randomization visits meets the criteria of MSSBP ≥180 mmHg or MSDBP ≥110 mmHg, among other conditions. \- Methods: This study is a multicenter, randomized, double-blind, parallel-group, phase 2b clinical trial to evaluate the safety and efficacy of the investigational drug after 8 weeks of administration. Screening assessments will be conducted within 4 weeks prior to randomization, and patients who meet the inclusion and exclusion criteria at the screening visit will be enrolled in the study after providing informed consent. These participants will undergo a 2-week run-in period during which they will take a placebo and participate in a lifestyle modification program.

Effects of Aerobic Exercise on Cognition,cerebral Brain Flow and Mental Health Among Traumatic Brain Injury Patients

The aim of this study is to develop exercise prescription of TBI patients and then to evaluate the effectiveness of programmed aerobic walking exercise to improve cognitive performance, depression relief, motivation, symptom, resilience and quality of life with improvement of CBF. This will be a randomized controlled clinical trial, using a mixed method to explore the feasibility and validity of such a safety exercise prescription. Then, a randomized clinical control trial will be applied in TBI patients to evaluate the effectiveness of programmed aerobic exercise to promote psysical-psycho-social health such as cognitive status, 6 minutes walk test, depression relief, motivation, symptom, resilience and quality of life.

Screening Of CoRonary ArTEry diSease

This study is a randomized trial with the objective of comparing the cost-effectiveness of the 2 recommended strategies: CCTA vs functional tests, allowing the evaluation of the quality of life of these patients in relation to the health resources used. In symptomatic patients with an intermediate probability of having stable CAD, i.e., whose pretest or clinical probability does not allow the elimination of the disease, and in patients without anginal symptoms for low levels of exercise who do not respond to medical therapy, in France, the diagnostic care pathways have become mature enough to set up a pragmatic prospective randomized trial with the objective of comparing the cost-effectiveness of the 2 recommended strategies: CCTA vs. Probabilistic medico-economic reasoning makes it possible to establish this two-way hypothesis more easily than in clinical research without the need to impose the superiority of one of the strategies.

France PCI Registry : National Observatory of Interventional Cardiology

Rigorous clinical practice assessment is a key factor to improve patient's care and prognosis in interventional cardiology (IC). A multicentric IC observational study (CRAC), fully integrated to usual coronary activity report software, started in Centre Val de Loire (CVL) region in 2014. CRAC observatory was conduced on five IC CathLab of CVL region. Quality of collected data is regularly evaluated and allowed building an exhaustive, and reliable database. This solution could easily be developed in other French regions.