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Myocardial Ischemia clinical trials

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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: NCT05929313 Active, not recruiting - Clinical trials for Coronary Arteriosclerosis

Scoreflex TRIO - Scoring PTCA Catheter

Start date: April 27, 2023
Phase: N/A
Study type: Interventional

To evaluate the acute safety and device procedural success of the Scoreflex TRIO Scoring PTCA catheters versus Scoreflex NC Scoring PTCA catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention.

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.

NCT ID: NCT05896982 Active, not recruiting - Clinical trials for Myocardial Infarction

Optimizing Patient Experience During Myocardial Perfusion Imaging

OPTIMIZE
Start date: November 2, 2022
Phase: N/A
Study type: Interventional

The present study focusses on the effects of the diagnostic testing environment on psychological wellbeing, cardiac symptoms and patient satisfaction during cardiac stress testing (CST) in patients who are referred to the Institute Verbeeten for SPECT myocardial perfusion imaging (MPI). The diagnostic procedure consists of two days of MPI using SPECT: day 1 of MPI involves obtaining a resting image and day 2 (typically 3 or 4 days later) a stress MPI following exercise or pharmacological challenge with adenosine. The diagnostic procedure can result in undesirable effects on psychological wellbeing, such as anxiety or psychological distress. These effects can be related to anticipatory anxiety (day 1 of MPI) and/or responses to the exercise or adenosine stress testing (day 2 of MPI). The present investigation aims to develop methods to further improve patients' experiences and wellbeing during the diagnostic process for the presence of inducible myocardial ischemia. This research project will compare four groups to establish the effect of providing information and supportive coaching: (1) care as usual, (2) information support using video materials, (3) supportive coaching during the diagnostic testing procedure, and (4) a combination of both interventions. The video-based information and supportive coaching are aimed at reducing feelings of anxiety, uncertainty and psychological distress during the diagnostic testing procedure. In addition to standardized self-report questionnaires, this project will utilize facial expression analysis software to measure emotional states during CST as well as 24- hour ambulatory assessments to evaluate autonomic nervous system activity, cardiac symptoms and psychological wellbeing during everyday life activities in the period between the two days of MPI. It is hypothesized that additional video-based information and supportive coaching during the diagnostic process for the inducibility of myocardial ischemia will result in improved psychological wellbeing (reduced acute negative emotions; primary outcome) as well as less cardiac and other physical symptoms and improved patient satisfaction (secondary outcomes) of the diagnostic clinic visit. The innovative aspect of the present proposal is its focus on emotional expression during evaluation for myocardial ischemia using FaceReader software in combination with self-reported momentary mood and perceived stress assessments. Knowledge about the interaction between psychological wellbeing and cardiac function obtained in this project will strengthen the development of future interventions aimed to reduce symptom burden and psychological distress in patients undergoing diagnostic evaluations for heart disease.

NCT ID: NCT05874752 Active, not recruiting - Clinical trials for Coronary Artery Disease

Myocardial Function Assessment in Patients With Coronary Artery Disease Using Noninvasive Myocardial Work

Start date: October 1, 2021
Phase:
Study type: Observational

Noninvasive pressure-strain loop (PSL) derived myocardial work (MW) are more sensitive than conventional echocardiographic parameters in quantitative assessment of early myocardial dysfunction. The aim of this study was to assess left ventricular (LV) myocardial function in symptomatic patients with coronary artery disease using the promising method. Methods: Transthoracic echocardiography was performed on patients with angina or equivalent symptoms before coronary angiography. Images were stored and imported into the software for further offline analysis of PSL-based MW. MW analysis were carried out on each patient for global and regional myocardial function assessment.

NCT ID: NCT05843487 Active, not recruiting - Clinical trials for Coronary Artery Disease

Association Between Carotid Plaque Length and Cardiovascular Outcomes

Start date: January 1, 2017
Phase:
Study type: Observational

This multicenter study involved 5 hospitals (Changhai Hospital; Yueyang Hospital of Shanghai University of Traditional Chinese Medicine; Gongli Hospital; Putuo Hospital of Shanghai University of Traditional Chinese Medicine; No. 904 Hospital of the PLA Joint Logistics Support Force Wuxi). The study enrolled 5000 consecutive patients without known CAD who underwent first coronary angiography for stable chest pain and carotid ultrasound was performed during hospitalization from January 2017 through December 2018.

NCT ID: NCT05841082 Active, not recruiting - Clinical trials for Coronary Artery Disease

Coronary Revascularization in Patients On Dialysis in China-Retrospective Registry

CRUISE-R
Start date: January 1, 2015
Phase:
Study type: Observational

Coronary artery disease (CAD) is the leading cause of death in end-stage renal disease (ESRD) patients requiring dialysis. There are limited data on clinical characteristics, treatment strategies and outcomes in this special patient population in China. As a nationwide, observational, multicenter cohort study, this study consecutively included ESRD patients on dialysis with significant CAD at 30 tertiary care centers in 12 provinces in China from January 2015 to June 2021. Patient data collected included demographics, comorbidities, cardiac history, cardiac function, location and severity of CAD, procedural information, medications, and clinical events.

NCT ID: NCT05820295 Active, not recruiting - Stroke Clinical Trials

Improving How Older Adults at Risk for Cardiovascular Outcomes Are Selected for Care Coordination

Start date: May 17, 2023
Phase: N/A
Study type: Interventional

This pragmatic clinical trial embedded in an accountable care organization will determine the comparative effectiveness of two approaches for assigning care coordinators to older adults at risk for cardiovascular outcomes. The hypothesis is that assigning care coordinators to older adults based on perceived need will be more effective at preventing emergency department visits and hospitalizations compared to usual care.

NCT ID: NCT05787886 Active, not recruiting - Clinical trials for Acute Coronary Syndrome

Rotational Atherectomy: Long-term Results From a Single Center Experience

RA-BIA
Start date: May 1, 2007
Phase:
Study type: Observational [Patient Registry]

The RA-BIA Registry is a single-center observational study. The study included consecutive patients from 2008 who met inclusion criteria and were treated with RA. The main aim of the study is to assess the efficacy of rotational atherectomy.

NCT ID: NCT05772754 Active, not recruiting - Clinical trials for Coronary Heart Disease

Molecular Pathways Involved in Cardiac Remodeling in Patients With Chronic Heart Failure With Preserved Ejection Fraction by New Omics Technologies

HFpEF
Start date: December 18, 2020
Phase: Early Phase 1
Study type: Interventional

Heart failure with preserved ejection fraction nowadays affects about half of all patients with heart failure. In the general population, the prevalence of this subclass of heart failure (HFpEF, ed.) increases as the age of patients increases, especially in those over 65 years of age, and it has a significant gender. The study is to investigate the molecular pathways, predominantly protein patterns, involved in cardiac remodeling peculiar to heart failure with preserved ejection fraction (HFpEF) by comparing them with remodeling pathways and protein pattern alterations in patients with HFrEF. In addition, the study aims to identify molecular alterations that would allow early identification of the development of PH-HFpEF and PH-HFrEF, affecting the female gender more