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Atherosclerosis clinical trials

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NCT ID: NCT04539145 Active, not recruiting - Atherosclerosis Clinical Trials

CHOCO-CABANA Trial

Start date: August 4, 2020
Phase: Phase 4
Study type: Interventional

The study will be performed 120 patients at about 6 to 8 study centers. Only patients with clinical conditions requiring assessment of patency of the treated BTK lesions at 6 months post procedure by MRA as part of standard care to prevent amputations as consequence of non-detected re-stenosis/occlusions will be included in the study. The sequence in which the individual patients will be treated will be randomized with the Chocolate PTA balloon and the uncoated conventional PTA balloon at each center. 60 patients will be randomized to uncoated conventional PTA balloon treatment and 60 patients to treatment with the Chocolate PTA balloon. All lesions in each patient (lesions that fulfill the inclusion/exclusion criteria) should be treated as the patient is randomized. In patients with long lesions more than one balloon may be used. Overlapping of balloons (at least 10mm) is mandatory to avoid untreated gaps between sequential treatments. Follow up will be performed at 1 and 6 months.

NCT ID: NCT04483167 Active, not recruiting - Clinical trials for Cardiovascular Diseases

Clinical Transfer of a Vulnerable Atherosclerotic Plaque Tracer : 99mTc-cAbVCAM1-5 (ATHENA)

ATHENA
Start date: September 15, 2020
Phase: Phase 1
Study type: Interventional

Clinical Transfer of a Tracer of the Vulnerable Atheroma Plate: 99mTc-cAbVCAM1-5. (ATHENA). This is a phase I/IIa, prospective, monocentric, non-controlled, non-randomized, open-label, interventional study.

NCT ID: NCT04462159 Active, not recruiting - Clinical trials for Coronary Artery Disease

The Young Heart Study

Start date: May 27, 2020
Phase: N/A
Study type: Interventional

The purpose of our project is to better understand the characteristics of the young patients with coronary artery disease presenting for cardiac catheterization at our institution and to put forth a program to optimize their risk factors with a focus on gender differences. We will assess traditional and non-traditional risk factors, as well as genetics and environment. These characteristics will be compared by gender to determine unique factors related to women that could subsequently be targeted. The program will begin with universal education about the process of atherosclerosis, risk factors contributing to the disease and specific risk factor goals for each patient for the 6 month program. The patients will then be part of a bimonthly 6 month cardiovascular risk reduction program that will offer both a nutritional program with teaching kitchen component, and exercise instruction lead by an exercise physiologist. Psychological support will be provided to address stress that impairs quality of life, depression or anxiety to fully optimize the lifestyle component. These sessions will be done virtually in order to comply with social distancing until in person sessions can resume. The investigational endpoints of this program will include a variety of cardiovascular disease (CVD) risk factors, biomarkers, lifestyle behaviors, quality of life and guideline-based medical regimen. At the end of this phase, we aim to both better understand differences in risk factors and the interventions with the biggest impact in terms of risk factor optimization in men vs. women.

NCT ID: NCT04382963 Active, not recruiting - Stroke Clinical Trials

Stroke Prevention in the Wisconsin Native American Population

Start date: April 14, 2021
Phase: N/A
Study type: Interventional

This project will develop a "Stroke Awareness Team" including training of Oneida Health Service Coaches working in partnership with the UW team for a population-based health awareness program. This team will develop a series of Oneida Nation Healthy Living and Stroke Awareness Events (from now on health events) to provide education as to the severity of the problem as well as our standard therapies for lifestyle change and risk factor avoidance. This will include education of the healthy members of the tribe including the children to identify signs of stroke and TIA in their elders as well as to develop healthy lifestyles at the earliest of ages to influence the elders to modify their risks.

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: NCT04167761 Active, not recruiting - Clinical trials for Cardiovascular Diseases

Ertugliflozin: Cardioprotective Effects on Epicardial Fat

Start date: July 1, 2020
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to learn if Sodium-Glucose Cotransporter 2 inhibitor (SGLT2i) medications enhance beneficial properties of epicardial adipose tissue including metabolic flexibility, insulin sensitivity, decreased cell size and reduced inflammation.

NCT ID: NCT04152291 Active, not recruiting - Clinical trials for Cardiovascular Diseases

The Effect of E-EPA on Circulating LDL and Plasma Lipid Metabolism

EPA&LDL
Start date: November 12, 2019
Phase: N/A
Study type: Interventional

40-70 healthy volunteers of ages 18 to 65 participate in a E-EPA-diet where 3,9 grams of E-EPA is added to their normal diet and lifestyles for a month. Blood samples will be collected before the study and at weeks 1 and 4 and also, two weeks after finishing the diet. Main study focuses are LDL aggregation susceptibility, lipid composition and proteoglycan binding affinity. In addition, important plasma lipid metabolism enzymes and lipid mediated resolvins are measured as well as several baseline characteristics.

NCT ID: NCT04148833 Active, not recruiting - Clinical trials for Coronary Artery Disease

Treatment of Patients With Atherosclerotic Disease With Paclitaxel-associated to LDL Like Nanoparticles

PAC-MAN
Start date: June 23, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators propose a prospective, randomized, double-blind, placebo-controlled study. The purpose of the study is to evaluate the safety and efficacy of an anti-proliferative agent paclitaxel in a cholesterol-rich non-protein nanoparticle (Paclitaxel -LDE) in patients with stable coronary disease. Patients with multi-vessels stable coronary disease will be randomized to receive Paclitaxel-LDE IV or placebo-LDE IV each 21 days for 6 weeks. The primary and main secondary endpoints will be analyzed by coronary and aortic CTA, that will be performed 1-4 weeks after randomization and at 3-8 weeks after the last treatment cycle. Patients will undergo clinical and laboratory safety evaluations before each treatment cycle and 3-8 weeks after the last cycle. An algorithm for drug suspension based on clinical and laboratory finding will be followed.

NCT ID: NCT04037293 Active, not recruiting - Atherosclerosis Clinical Trials

Premature Atherosclerosis in Systemic Lupus Erythematosus

PASLE
Start date: May 1, 2013
Phase:
Study type: Observational [Patient Registry]

Patients with SLE have increased rates of atherosclerosis, while the risk factors for atherosclerosis in those patients were not fully revealed. This study is an observational study to investigate the natural process and risk factors for atherosclerosis based on a Chinese SLE cohort. Carotid intima media thickness (CIMT) and brachial-ankle pulse wave velocity (baPWV) will be measured for each patient at baseline and 5-year follow-up. Blood tests including cholesterol levels, fasting plasma glucose levels and etc. will also be performed.

NCT ID: NCT03949829 Active, not recruiting - Clinical trials for Cardiovascular Diseases

The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study

CPH-PRECIOUS
Start date: May 20, 2019
Phase:
Study type: Observational [Patient Registry]

Women with a history of preeclampsia (PE) have increased risk of hypertension and cardiovascular disease (CVD) later in life. Thus, PE is acknowledged as an independent risk factor for CVD, which is the number one cause of death in women in the western part of the world. Objective: The purpose of this study is to investigate 1) the prevalence of CVD after PE, 2) which women have the highest risk of developing CVD, 3) when early stages of CVD can be detected in women with previous PE and 4) how CVD progress over time. Methods: 1000 women with previous PE between the age of 35-55 years will be invited to participate in a follow-up study consisting of anthropometric measurements, blood pressure measurement, urine- and blood samples, cardiac CT-scan and questionnaires. Coronary atherosclerosis will be evaluated using CT imaging.The women will be compared with women with a formerly uncomplicated pregnancy, Summary: The study will provide new important information to guide future clinical follow-up, and potentially prevent disease and early death in a large group of women with a history of PE.