Clinical Research Directory

SIALIDASE INHIBITION AS ANTIATHEROSCLEROTIC THERAPY

The aim of this double-blind, randomized, placebo-controlled, multicenter study is to evaluate the pathogenetic effects of the dietary supplement "Tertinat" on a fundamental mechanism of atherosclerosis development: its ability to inhibit pathological desialylation of low-density lipoproteins (LDL). According to the protocol's scientific hypothesis, the loss of sialic acid from the surface of LDL converts them into highly atherogenic particles, which are actively captured by vascular macrophages, triggering the formation of unstable atherosclerotic plaques. Over 24 months of daily administration of 330 mg of epigallocatechin-3-gallate, along with standard therapy, will evaluate not only the incidence of major cardiovascular events (MACE) in atherosclerotic patients who have undergone the procedure of surgical revascularization, but also the direct dynamics of recovery of sialic acid levels in LDL particles in patients' blood. The study aims to confirm that preventing LDL desialylation reduces overall serum atherogenicity, prevents cholesterol accumulation within macrophages in vivo, and thereby provides a proven clinical effect - a reduced risk of myocardial infarction, stroke, unstable angina, heart failure, and the need for repeated revascularization in patients after coronary artery bypass grafting or stenting.

Comprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery

Apply CT angiography, CT perfusion imaging and advanced image processing techniques to improve revascularization decision-making and surgical strategies in patients undergoing coronary artery bypass graft surgery.

Gut Microbiota Modulation With Synbiotics After Acute Coronary Syndrome

Acute coronary syndrome (ACS) remains one of the leading causes of morbidity and mortality worldwide despite major advances in acute management and secondary prevention. Gut dysbiosis has been described as linked to cardiovascular events. Modulating the gut microbiota through symbiotics-a combination of probiotics and prebiotics-represents a promising, low-risk and widely accessible strategy to influence these pathways and contribute to the enhancement of cardiovascular prevention, with regards to the global burden as well as health costs. The SYMBIO-ACS study is therefore designed to assess the effects of a symbiotic intervention on TMAO levels and identify new cardiometabolic biomarkers in patients following ACS, providing essential pilot data for future larger-scale preventive trials.

Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease

Atherosclerotic cardiovascular disease (ASCVD) remains a leading cause of morbidity and mortality worldwide and in Norway. Approximately 50% of the patients admitted to hospitals with an acute ASCVD event has had a previous event. The high number of patients being readmitted to hospitals with new ASCVD events is to a large degree explained by poor control of established risk factors such as high LDL-cholesterol, high blood pressure (BP), diabetes, obesity, smoking, and lack of physical activity, as well as poor adherence to evidence-based medication. This pragmatic, open-label proof-of-concept study conducted at three secondary care hospitals will randomly assign patients hospitalized with an ASCVD event to either: (i) brief advice, tailored discharge information to general practitioners, and a nurse-led outpatient visit (control), or (ii) the same interventions as (i) plus a single in-hospital motivational counselling session and access to a digital platform for a 6 months period with patient information/videos and an individualized treatment plan and follow-up plan. The primary end point will be between-group differences in the proportion who report having attended follow-up visits in primary (primary care physicians and community-based healthy life centres) and specialist (cardiac rehabilitation programs, hospital outpatient visits) healthcare after 8 weeks and 6 months follow-up. Secondary end points will be change in the SMART2 risk score and cardiovascular risk factors between baseline and 6 and 12 months follow-up. Exploratory end points will be changes in adherence to cardiovascular drugs, self-care behaviour, health literacy, patient activation, and quality of life.

Concurrent OCT and FFR-guided PCI in CAD

The present study is a prospective randomized clinical trial aimed to compare the therapeutic strategy of angiography-guided versus concurrent OCT/FFR-guided intervention in patients with coronary artery disease.

Long Term Follow-up of Comparison of Clopidogrel vs. Aspirin Monotherapy After Drug-eluting Stent Implantation

This is an retrospective extended study of a randomized clinical trial (The HOST-EXAM trial ClinicalTrials.gov Identifier: NCT02044250). Investigators will perform a retrospective analysis of all participants enrolled in this trial will be performed, until the longest follow-up duration.