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Atherosclerosis, Coronary clinical trials

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NCT ID: NCT06280976 Recruiting - Clinical trials for Coronary Artery Disease

Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)

ARTCAP
Start date: March 1, 2024
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effect medication on your heart. All patients between 18-80 years of age, at intermediate or high risk for coronary heart disease (calculated based on age, gender, race, and history of smoking, diabetes, high blood pressure, high cholesterol, family history of early coronary heart disease) with/without symptoms suggestive of heart disease, including chest pain or shortness of breath on exertion, will be selected to take part in this study. CT scan will be used to assess to see if the prescribed treatment changes the blood vessels in heart. The investigators are doing this study because they want to develop better tools to predict, diagnose, and treat coronary heart disease. This research will help improve care for patients with coronary heart disease by evaluating heart vessel narrowing and improving the decision-making for treatment.

NCT ID: NCT05600088 Recruiting - Clinical trials for Coronary Artery Disease

Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With NSTEMI or Unstable Angina

POLARSTAR
Start date: October 18, 2022
Phase: N/A
Study type: Interventional

The POLARSTAR study is an early safety and feasibility study to evaluate the performance and safety of the CryoTherapy System (CTS) for the treatment of coronary plaque lesions that are not obstructing blood flow but are at high-risk of rupture which would cause a major heart attack. The CTS is used to apply local freezing of the lesion using a balloon catheter, controlled by a console that regulates in- and outflow of a cooling agent into the catheter. The treatment is expected to stabilize the lesion, diminishing the risk of rupture. The study will enrol subjects with acute coronary disease who have suitable coronary lesions. Subjects will be followed for 1 year after the CTS treatment. Baseline identification of lesions will be done using Coronary CT-angiography (CCTA), which will be repeated at 3 and 9 months after procedure.

NCT ID: NCT05540223 Not yet recruiting - Clinical trials for Coronary Artery Disease

Safety and Clinical Performance of the DREAMS 3G Resorbable Magnesium Scaffold System

BIOMAG-II
Start date: April 2024
Phase: N/A
Study type: Interventional

The objective of this study is to assess the safety and efficacy of the DREAMS 3G in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to a contemporary drug eluting stent (DES).

NCT ID: NCT05492084 Completed - Clinical trials for Atherosclerosis, Coronary

Personalized Risk of Rapidly Progressive Atherosclerosis

RPA
Start date: January 1, 2019
Phase:
Study type: Observational

Вackground. Progressive atherosclerosis is accompanied by unfavorable clinical outcomes, study and understanding of this process, creation of risk assessment method is necessary for individualization of approaches to treatment and prevention of this condition. Purpose of the study. Creation of a mathematical model to assess the risk of accelerated atherosclerosis development, using methods of factor and correlation analysis. Patient Characteristics and Study Methods. A retrospective cohort study included 202 patients with coronary heart disease. Group 1 included patients who had had myocardial infarction or unstable angina, emergency arterial stenting, stroke, peripheral artery thrombosis, critical ischemia, and lower extremity amputation within 2 years before study inclusion. Patients in the comparison group did not have these events. The influence of each of the studied parameters on the probability of fast progressing atherosclerosis was determined by factor and correlation analysis. The prospective part of the study will include follow-up of patients from both groups for 12 months. Annual "endpoints": fatal outcome, unscheduled coronary revascularization, nonfatal myocardial infarction and stroke, hospitalization due to unstable angina pectoris, stent thrombosis, stenting/plasty of lower limb arteries.

NCT ID: NCT04853511 Recruiting - Inflammation Clinical Trials

Comprehensive Assessment of Interconnection Between Brain Emotional Activity and Coronary Plaque Instability

Start date: February 14, 2022
Phase:
Study type: Observational [Patient Registry]

Emotional stress is associated with future cardiovascular events. However, the biological interconnection between brain emotional neural activity and acute plaque instability is not fully understood. Optical coherence tomography-Fluorescence Lifetime (OCT-FLIM) dual modal intravascular imaging is a novel technique that enables comprehensive assessment of structural and biochemical characteristics of coronary atheroma and estimates the level of plaque instability. 18F-fluorodeoxyglucose-positron emission tomography/computed tomography (18F-FDG-PET/CT) enables simultaneous estimation of multi-system activities including emotional stress, arterial inflammation, and hematopoiesis. The present study aims to prospectively investigate mechanistic linkage between coronary plaque instability, stress-associated neurobiological activity, and macrophage hematopoiesis using OCT-FLIM and 18F-FDG PET/CT imaging assessment.

NCT ID: NCT04810364 Enrolling by invitation - HIV Infections Clinical Trials

HIV Infection And Evolvement of Atherosclerotic Plaque

HIVE
Start date: January 5, 2020
Phase:
Study type: Observational [Patient Registry]

In a prospective multi-center observational study, 200 HIV-infected patients treated with antiretroviral treatment (ART) and who suffered from coronary artery disease (CAD) will be enrolled. Blood samples for biological parameters will be collected with all participants: lipid profile and markers of systemic inflammation specific for HIV-infection (lipopolysaccharide-binding protein; cytokines: IL-1β, IL-6, IL-8, IL-10, TNF -α, INF-γ, INF-α; procalcitonin; inflammatory hsCRP). All of them will undergo functional testing (Echo, CMR both at rest and stress if necessary) and invasive imaging with QCA, FFR, QFR, OCT, IVUS, VH-IVUS, NIRS. Patients will be treated according to the current and previous recommendations. Both medical treatment and percutaneous transluminal coronary angioplasty (PTCA) with or without stenting will be done. Collected data will be analyzed: correlation between ART, blood test results, coronary angiography results, including performed PTCA, history of myocardial infarctions, and other cardiovascular events. The follow-up period will achieve 12 months prospectively with collected clinical events and imaging outcomes which will be determined at the baseline and 12-month follow-up. The independent ethics expertise will be provided by the Central Clinical Hospital of the Russian Academy of Sciences (Moscow, Russia). The monitoring of the clinical data with imaging will be provided by The Ethics Board of Central Clinical Hospital of the Russian Academy of Sciences.

NCT ID: NCT04762472 Not yet recruiting - Clinical trials for Atherosclerosis, Coronary

Air Pollution (PM2.5) on Accelerated Atherosclerosis: A Montelukast Interventional Study in Modernizing China

Start date: September 2023
Phase: Phase 4
Study type: Interventional

Background: Longterm exposure to air pollution has been associated with cardiovascular events and mortality on top of traditional risk factors. Pulmonary inflammation and oxidative stress have been implicated. Brachial (arm) vascular reactivity (flow-mediated dilation FMD) and carotid (neck) artery intima-media thickness (CIMT) are highly reproducible atherosclerosis surrogates, predictive of cardiovascular and stroke outcome. Montelukast is proven safe and effective in alleviating pulmonary inflammation and oxidative stress when used in prevention of asthma episode. Study objectives: 1. To test the hypothesis of pulmonary inflammation and oxidative stress-related vascular dysfunction in PM air pollution. 2. To evaluate the impact of Montelukast treatment as compared with placebo on predictive atherosclerosis surrogates (FMD and IMT). Design: Parallel placebo control, randomized comparative study. Subjects will be randomized to take Montelukast (10mg/daily) or image-matched placebo for 26 weeks. Measures will include PM2.5/PM10, indices of subclinical atherosclerosis (brachial FMD and CIMT), blood inflammatory biomarkers (platelet counts, hsCRP and fibrinogen) and potential confounders (lipids and glucose). Setting: 120 working adults aged 30-60 years in Hong Kong and 80 working adults in Chongqing (CREC Ref No: 2018.157, 2020.398) Main outcome measures: 1. Subclinical atherosclerosis: (a) Endothelial function (brachial FMD) and (b) carotid intima media thickness (CIMT). 2. PM2.5 & PM10 concentrations: real-time measurement by portable devices twice at home and work sites. 3. Blood inflammatory markers-platelet count, hsCRP and Fibrinogen 4. Potential confounders: we shall collect informations on a range of potential confounders, including other air pollutants and traditional risk factors of atherosclerosis, entrusted to be controlled (stable). Expected results: Adults after Montelukast treatment and exposed to high levels of PM2.5 or PM10 would have improved (increased) brachial FMD, and reduction of CIMT as compared with placebo. These will have great implication for comparative vascular epidemiology and development of preventive strategies.

NCT ID: NCT04175626 Active, not recruiting - Clinical trials for Coronary Artery Disease

Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions

BIOFLOW-VII
Start date: January 24, 2020
Phase:
Study type: Observational

The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device Exemption pivotal trial, as a condition of the US Food and Drug Administration (FDA) approval (P170030).

NCT ID: NCT03815032 Completed - Clinical trials for Coronary Artery Disease

Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison

ACCURACY
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

The goal of the ACCURACY study is to assess the differences, if any, in FFR measurements made by the OptoWire Deux FFR guidewire by comparison of simultaneous data of two different OptoWire DeuxTM guidewires (group 1). In addition, the investigators will compare (group 2) the FFR measurements obtained from an OptoWire Deux FFR guidewire and compare it to the FFR measurement by a VERRATA-TM guidewire to assess coronary stenosis in the routine clinical practice.

NCT ID: NCT03813017 Not yet recruiting - Clinical trials for Cardiovascular Diseases

Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

Start date: October 2019
Phase:
Study type: Observational [Patient Registry]

Cardiovascular disease is a leading cause for morbidity and mortality in general population. The incidence of cardiovascular disease and their poor outcome is well documented in a broad spectrum of connective tissue diseases, especially in rheumatoid arthritis (RA). The risk of incident CVD is increased by 48% in patients with RA compared to the general population. RA is associated with 50% increase in the mortality in patients with cardiovascular disease (CVD). One reason is the more frequent cardiovascular risk factors in RA patients compared with the general population. Patients with RA have a high risk of premature cardiovascular disease (CVD). The aim of the present study is to assess whether there are non-invasive measures that might predict arteriosclerosis in RA patients.