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Coronary Artery Disease clinical trials

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NCT ID: NCT06242171 Active, not recruiting - Clinical trials for Coronary Artery Disease

Prognostic Indices of Atheromatosis Severity and Coronary Artery Bypass Surgery Outcomes for Patients With Coronary Artery Disease

Start date: October 30, 2020
Phase:
Study type: Observational

Coronary artery disease is a multifactorial disease. Traditional risk factors, such as obesity, diabetes, hypertension, stimulate the onset of an inflammatory process in the prone vessel and perivascular adipose tissue, which has not yet been clarified and is still being investigated. Coronary artery bypass grafting is an effective treatment of coronary artery disease, which has been shown to prolong survival. Perioperative analysis of the myocardial metabolic profile helps to identify appropriate markers and metabolites associated with early myocardial damage. This, in turn, helps to improve risk stratification by better understanding the mechanisms of the disease processes, in order to prevent postoperative myocardial infarction and its associated complications. Such indicators, which are related to the diagnosis and severity of coronary artery disease, as well as the prognosis of coronary artery bypass grafting, have been separately studied before, in the peripheral blood of patients with coronary artery disease, in healthy vascular tissues, such as mammary artery, compared to atherosclerotic tissue from the coronary artery, as well as in the epicardial adipose tissue, intraoperatively. The aim of the proposed study is to investigate and evaluate metabolic factors and biomarkers preoperatively, intraoperatively and postoperatively, in patients undergoing coronary artery bypass grafting and their prognostic value regarding a) the severity of coronary artery disease (Gensini score, ejection fraction, acute coronary syndrome) and b) the outcome of surgery (indications of myocardial damage and / or infarction, low cardiac output syndrome and use of intraortic balloon pump, atrial fibrillation, 30-day mortality).

NCT ID: NCT06235424 Active, not recruiting - Clinical trials for Aortic Valve Disease

Del Nido Versus HTK Cardioplegia in Adult Aortic Valve Replacement

Start date: October 1, 2018
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare del Nido and Bretschneider-HTK (HTK) cardioplegia solutions in patients undergoing elective aortic valve replacement. The main question it aims to answer is: • Does the del Nido cardioplegia provide better cardioprotection and clinical outcomes than HTK cardioplegia? Participants will receive one of the investigated cardioplegia solutions according to the randomization. Researchers will compare both groups in terms of cardioprotection (described as levels of CK-MB and hsTnI), in-hospital clinical outcomes, biochemical changes in coronary sinus blood and one-year follow-up.

NCT ID: NCT06183294 Active, not recruiting - Clinical trials for Stable Angina, Unstable Angina, NSTEMI

Evaluation of a Novel Non-Invasive Automated Fractional Flow Reserve Software System in Patients With Coronary Artery Disease

Start date: August 22, 2023
Phase:
Study type: Observational

This retrospective study will evaluate the coronary angiograms of approximately 100 patients who have undergone invasive angiography and fractional flow reserve (FFR). DICOM files of the angiograms will be analyzed on a secure computer within the cardiac catheterization laboratory using the AutocathFFR software to assess if invasive FFR measurements and automated computer analysis of FFR measurements correlate. AutocathFFR measurement per lesion will be compared to the gold standard, invasive FFR value, where an FFR ≤ 0.80 will be considered "positive", while an FFR > 0.8 will be considered "negative". The AutocathFFR value will be compared to the invasive FFR measurements. The sensitivity and specificity of the AutocathFFR will be calculated, as well as the AutocathFFR accuracy, positive predictive value and negative predictive value per lesion. Device success will be calculated as the ratio of completed versus initiated AutocathFFR index calculations. Usability of the AutocathFFR software will be evaluated using dedicated questionnaires to be completed by the user (cardiologists).

NCT ID: NCT06172985 Active, not recruiting - Clinical trials for Coronary Heart Disease

A CCTA Image Assisted Triage Software for the Assessment of Patients With Suspected Coronary Artery Disease

Start date: May 9, 2023
Phase:
Study type: Observational

The goal of this clinical trail is to evaluate the effectiveness and accuracy of the CCTA image assisted triage software(DeepVessel® Cardisight, Keya Medical.) for the triage of patients with suspected coronary artery disease.

NCT ID: NCT06164977 Active, not recruiting - Clinical trials for Coronary Artery Disease

Chronic Total Coronary Occlusion Treatment Results 6 Years After Bioresorbable Scaffold Implantation

CTO_BVS
Start date: February 1, 2017
Phase: N/A
Study type: Interventional

Aim of the study is to evaluate chronic total coronary occlusion treatment results 6 years after bioresorbable scaffold implantation by quantitative coronary analysis, intravascular ultrasound and optical coherence tomography.

NCT ID: NCT06010498 Active, not recruiting - Clinical trials for Coronary Artery Disease

The Effect of Eye Mask Applied on Patients Undergoing Coronary Artery Bypass Graft Surgery

Start date: July 10, 2023
Phase: N/A
Study type: Interventional

Introduction: Coronary Artery Bypass Graft (CABG) performed with open heart surgery technique is a successful operation in the treatment of cardiovascular diseases. Incision of the sternum region, saphenous vein graft, sternal retraction, presence of chest and mediastinal tubes cause pain. The pain experienced by the patients, the complications related to the disease they have, and the stress they experience cause an increase in sleep problems. In addition, the increase in sympathetic activity after surgery and nursing care interventions also affect sleep quality. The literature reports that sleep disorders affect the working physiology of the heart in patients with cardiac disease, adversely affect heart health and affect postoperative recovery. In addition, since sleep disorders are also associated with cardiovascular diseases, it is of great importance to improve the sleep quality of this group of patients. One of the non-pharmacological nursing interventions is the eye patch. The eye patch is an instrument made of fabric, with an elastic strap, aimed at pure darkness by diverting all light from the patient's eyes. The main physiological purpose of using an eye patch is to adjust the hormones melatonin and cortisol, which affect the circadian rhythm. As a result, it is thought that the eye patch will prevent patients from being exposed to excessive light in the hospital environment, the regulation of hormones and sleep quality will improve, and the pain will decrease. Purpose: The aim of this study is to examine the effect of eye patch applied to patients undergoing coronary artery bypass graft surgery on sleep quality and pain. Method: Individuals who have undergone coronary artery bypass graft surgery in accordance with the sampling inclusion criteria will be randomly assigned to the experimental and control groups by block randomization. After determining the groups, each patient in the experimental and control groups, whose written consent was obtained, will have the first researcher fill out the Descriptive Characteristics Form, Richards-Campbell Sleep Questionnaire and Numerical Pain Scale on the morning of the first night they spent in the clinic. Patients in the experimental group will be given the "standard care" and "eye patch" application in the clinic on their 2nd and 3rd nights in the clinic. The patients in the control group will only be provided with the "standard care" in the clinic on their 2nd and 3rd nights in the clinic. Patients in both groups will be asked to fill out the Richards-Campbell Sleep Questionnaire and Numerical Pain Scale forms in the mornings of the 2nd and 3rd nights.

NCT ID: NCT06008041 Active, not recruiting - Clinical trials for Coronary Artery Disease

Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations (PHYCO)

PHYCO
Start date: July 13, 2023
Phase:
Study type: Observational

When performing coronary angiography in a stable situation, the identification of an intermediate coronary lesion (between 50 and 70%) is common, and requires additional functional evaluation. The gold standard for this evaluation is Fractional Flow Reserve (FFR). FFR is a flow ratio transformed into a pressure ratio by simplification, neglecting some parameters, especially microcirculatory resistance. The aim of this study is to investigate hemodynamic and structural assessment induced in specific conditions, and their repercussion on functional assessment by FFR to implement the diagnostic approach and personalize it for each patient.

NCT ID: NCT05937230 Active, not recruiting - Clinical trials for Coronary Heart Disease

Drug-coated Balloons and Drug-eluting Stents in Diabetic Patients

Start date: June 1, 2015
Phase:
Study type: Observational [Patient Registry]

Drug-eluting stents (DES) have long been recommended as the default device for patients undergoing percutaneous coronary intervention (PCI). Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel-coated on the balloon. DCB angioplasty has the following advantages compared to DES implantation: Firstly, the drug in DCB is uniformly distributed and released, whereas the drug release of DES via the stent platform is uneven -85% of the vascular wall is not covered by the stent strut. Secondly, there is no alloy in the vessel after DCB angioplasty, while the coronary stent platform and polymer might cause temporal or persistent inflammatory response leading to intimal hyperplasia. Finally, there is no metal cage restraining vessel motion after DCB, and the physiological function of coronary arteries would be maintained. Currently, DCB constitutes an important treatment option in ISR, which is endorsed by the 2018 European Society of Cardiology Guidelines on myocardial revascularization. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice. Diabetes is associated with worse outcomes after coronary revascularization and has been identified as an independent predictor of adverse events in patients with cardiovascular disease. Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB is non-inferior to the drug-eluting stent (DES), there is still a lack of evidence comparing the DCB versus DES for de novo or ISR coronary lesions in diabetic patients. The current study aims to compare the long-term efficacy of DCB to DES in de novo or ISR coronary lesions in diabetic patients.

NCT ID: NCT05914246 Active, not recruiting - Clinical trials for Coronary Artery Disease

VIOLA Post Market Surveillance Clinical Protocol

Start date: July 5, 2023
Phase: N/A
Study type: Interventional

The goal of this post marketing surveillance clinical trial is to learn about VIOLA as a proximal seal device in patients undergoing coronary artery grafting (CABG) surgery. The main objective is to evaluate the clinical safety and performance of the VIOLA. Participants will be treated with routine CABG with use of VIOLA for maintaining hemostasis when suturing the proximal anastomosis. Patients will be followed for any clinical events at 6 weeks and 9 months post surgery.

NCT ID: NCT05913778 Active, not recruiting - Clinical trials for Coronary Artery Disease

Long-tErm Effects of Enhanced eXternal CountErpuLsation

EXCEL
Start date: December 10, 2020
Phase: N/A
Study type: Interventional

Enhanced external counterpulsation (EECP) is an effective non-invasive treatment in patients with coronary artery disease (CAD) which complicated by chronic heart failure (CHF). Aim: to study the long-term effects of treatment with enhanced external counterpulsation on the structural and functional state of the vascular bed in patients with stable CAD complicated by CHF. Patients (n=100) with verified stable CAD (class 2-3 angina) complicated by CHF (NYHA class 2-3) and receiving optimal drug therapy included in open randomized study. Primary randomization (2:1) + secondary randomization (1:1). - SHAM-counterpulsation group (ECP-SHAM; compression pressure 80 mm Hg; 35 procedures, 1 hour each); - Active counterpulsation group (ECP35; compression pressure 220-280 mm Hg; 35 procedures, 1 hour each) 1 course per year; - Active counterpulsation group (ECP70; compression pressure 220-280 mm Hg; 35 procedures, 1 hour each) 2 courses per year. Duration of observation is 3 years. Stages of examination: after 3, 6, 12, 24, 36 months (after 3, 6, 12 months for the ECP-SHAM group). Primary endpoint: combination of vascular event (myocardial infarction, acute cerebrovascular accident, revascularization procedures), hospitalization (for CAD/CHF), death. Secondary endpoints: changes in exercise tolerance, a needing for antianginal therapy, frequency of angina episodes. Objectives: to study the dynamics of the structural and functional state of the vascular bed (applanation tonometry, photoplethysmography, computer nailfold videocapillaroscopy), the dynamics of the clinical status (Clinical Status Assessment Scale), the dynamics of exercise tolerance (6-minute walk test), the dynamics of the quality of life of patients ( questionnaires SF36 and MLHFQ) in the ECP35 and ECP70 groups at baseline, at the end of the first course, after 6 months, 1, 2, and 3 years, and in the ECPSHAM group at baseline, at the end of the first course, after 6 and 12 months; (2) To investigate the impact of EECP on the incidence of primary (vascular events, hospitalizations for CAD/CHF, death) and secondary (frequency of angina episodes, need for antianginal drugs, exercise tolerance) endpoints. Expected outcome of the study: Obtaining reliable data on the long-term positive effect of EECP on the dynamics of the structural and functional state of the vascular bed, exercise tolerance, quality of life and prognosis in patients with stable CAD complicated by CHF.