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82 active trials for Ischemic Heart Disease

Low Dose Interleukin-2 in Patients With Stable Ischaemic Heart Disease and Acute Coronary Syndromes

The mainstay for treatment for acute coronary syndrome (ACS) focusses on re-establishing and maintaining the patency of vessels following coronary plaque disruption, through the use of anti-platelets and anticoagulants. Despite advances in management ACS still carries a high risk of morbidity and mortality, thus future management is likely to target other pathways. Recent studies indicate that CD4+ T cells, and more specifically Treg cells, are important for the control of post-ischemic immune responses and the promotion of myocardial healing. The investigators therefore hypothesise that expansion of Treg cells in patients with ACS dampens the activation of the immune response and promotes both plaque and myocardial healing. The investigators hypothesise that this can be achieved through subcutaneous administration of low doses of interleukin-2 (IL-2). IL-2 supplementation appears to be an attractive therapeutic option playing a key role in Treg cell development, expansion, survival and suppressive function.

Start: June 2017

Prediction and Validation of Clinical Course of Coronary Artery Disease With CT-Derived Non-Invasive Hemodynamic Phenotyping and Plaque Characterization

Acute coronary syndrome (ACS) and sudden cardiac death can be the first manifestation of coronary artery disease and are the leading cause of death in the majority of the world's population. The main pathophysiology of ACS is well-known and fibrous cap thickness, presence of a lipid core, and the degree of inflammation have been proposed as the key determinants of plaque vulnerability. Previous studies using virtual histology intravascular ultrasound or optical coherence tomography showed that clinical application of this concept improved risk prediction of ACS. However, these approaches have not been widely adopted in daily practice due to relatively low positive predictive values, low prevalence of high-risk plaques and the invasive nature of diagnostic modalities. Non-invasive imaging studies with coronary computed tomography angiography (CCTA) also showed the clinical value of CCTA-derived high risk plaque characteristics (HRPC). In addition, the recent progress in CCTA and computational fluid dynamics (CFD) technologies enables simultaneous assessment of anatomical lesion severity, presence of HRPC and quantification of hemodynamic forces acting on plaques in patient-specific geometric models. As plaque rupture is a complicated biomechanical process influenced by the structure and constituents of the plaque as well as the external mechanical and hemodynamic forces acting on the plaque, a comprehensive evaluation of lesion geometry, plaque characteristics and hemodynamic parameters may enhance the identification of high-risk plaque and the prediction of ACS risk. In this regard, the current study is designed to evaluate prognostic implications of comprehensive non-invasive hemodynamic assessment using CCTA and CFD in the identification of high risk plaques that caused subsequent ACS.

Start: April 2020

Effect of Remote Intervention in Patients With SCAD

The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated a remote intervention with 1 year of follow-up.

Start: April 2021

ENCOMPASS: Expansion Study C, RCT

Some patients living with multiple long-term health conditions have difficulty accessing the services they need, despite available primary care and community resources. Patient navigation programs may help those with complex health conditions to improve their care and outcomes. Community health navigators (CHNs) are community members who help guide patients through the health care system. CHNs are not health professionals like a doctor or nurse, but they are specially trained to help patients get the most out of their health care and connect them to resources. The ENCOMPASS program of research evaluates a patient navigation program that connects patients living with long-term health conditions to CHNs. To understand if the CHN program can be scaled to a provincial level, the ENCOMPASS program of research is expanding to select primary care settings across Alberta. This study implements and evaluates the CHN program at WestView Primary Care Network in the Greater Edmonton area, Alberta, Canada.

Start: June 2021

ENCOMPASS: Expansion Study A, RCT

Some patients living with multiple long-term health conditions have difficulty accessing the services they need, despite available primary care and community resources. Patient navigation programs may help those with complex health conditions to improve their care and outcomes. Community health navigators (CHNs) are community members who help guide patients through the health care system. CHNs are not health professionals like a doctor or nurse, but they are specially trained to help patients get the most out of their health care and connect them to resources. The ENCOMPASS program of research evaluates a patient navigation program that connects patients living with long-term health conditions to CHNs. To understand if the CHN program can be scaled to a provincial level, the ENCOMPASS program of research is expanding to select primary care settings across Alberta. This study implements and evaluates the CHN program at Edmonton Oliver Primary Care Network in Edmonton, Alberta, Canada.

Start: January 2021

Absorb GT1 Japan PMS

The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for evaluating clinical use results.

Start: December 2016

MRI Sequence and Imaging Protocol Development

The purpose of this study is to develop imaging protocols when using cardiovascular magnetic resonance (CMR) to assess cardiac functions, morphology and tissue characterization. The National Heart Research Institute Singapore (NHRIS) houses two dedicated CMR scanners to support the numerous investigator initiated projects in patients with various cardiac pathologists. By optimizing novel CMR sequences used in these studies, scanning time can be shortened for patients with underlying cardiac diseases.

Start: March 2016

Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia.

The Ripple VT-1 Study is a prospective clinical trial that aims to investigate if catheter ablation of ventricular tachycardia in patients with ischaemic heart disease can be effectively performed using Ripple Mapping.

Start: April 2019

Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose

Intranasal insulin is reported to improves memory performance in patients suffering from cognitive impairment. The investigators have previously shown that intraoperative insulin administration preserves both short and long-term memory function after cardiac surgery. Applying intranasal insulin bypasses blood-brain barrier and cause elevation of insulin concentrations in the cerebrospinal fluid without major effects on peripheral insulin level. Patients undergoing major surgery are exposed to carbohydrate and insulin metabolism alteration. The goal of the study is to study the effect of intranasal insulin on blood glucose, plasma and cerebrospinal insulin concentration in patients undergoing cardiac surgery or endovascular thoracic aneurysm repair.

Start: September 2016

Participatory Patient Care Planning in Primary Care

In the aging population, the prevalence of chronic diseases and multimorbidity has become common. Therefore, the planning and coordination of care have become more important. However, it is not known what kind of treatment plan should be and what kind of patients would benefit most of it. This research focuses on the participatory patient care planning in primary health care. In general, the participatory patient care planning (PPCP) aims to engage patients in self-care, to improve the collaboration between patients and professionals and to improve the use of resources. The present study investigates the feasibility and effectiveness of the PPCP. The specific research questions of the present study are: Does the PPCP have an impact on the patient's quality of life? Does the PPCP improve the quality of care in management of chronic diseases? Does the PPCP improve patient's commitment with self-care? Does the PPCP impact on the use of health care services? The data consists of people aged at least 18 years living in the municipality of Siilinjärvi with diabetes, coronary heart disease or hypertension and who are recorded in in Siilinjärvi Health Care Center electronic patient record. The participating patients are recruited from those who contacts SiiIinjärvi Health Care Center in order to have a follow-up visit because of the treatment of their disease. This study aims to recruit 700 patients. The participants are allocated into the intervention group and into the control group receiving usual care. Intervention consists of the PPCP. This includes the patient activation questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist measurement, weight and length) and a visit to the general practitioner who discusses and agrees with the patient about the treatment goals and follow-up resulting in the written PPCP. The main out-come measures are the quality of health related life measured with the 15D; the level of patient's activity in self-care with the Patient Activation Measurement (PAM); life satisfaction, self-rated health, a reduction in productivity with the Work Productivity and Activity Impairment Questionnaire (WPAI: GH), and the disease specific measures (blood pressure, HbA1C, LDL-cholesterol, body mass index and waist measurement). In addition, pain intensity and interference (NRS 0-10), mood (BDI-21), the number of visits and phone calls and referrals are measured.

Start: January 2017

Effect of Home Rehabilitation on State of Patients With PAH, HFREF and IHD

The aim of the study is to evaluate the influence of physical training and respiratory rehabilitation performed by patients at home on quality of life, symptoms, physical endurance, force of respiratory and skeletal muscles and body mass composition in patients with pulmonary arterial hypertension (PAH) or left ventricular heart failure with reduced ejection fraction - HFREF), or ischemic heart disease and evaluation the number of stem cells, natural lymphoid cells and distribution of subpopulations of monocytes (including proangiogenic monocytes) in examined persons and evaluation of theirs eventual influence of the course of disease.

Start: February 2016

The Randomized OPTIMAL-ACT Trial

Despite the widespread adoption of recommended anticoagulation intensity ranges during percutaneous coronary intervention (PCI), there are limited randomized clinical trials testing specific targets for activated clotting times (ACT). The primary research hypothesis is that in the modern cardiac catheterization laboratory, where PCI procedural duration is relatively short, radial access with small caliber equipment is preferable, and where rates of intracoronary stenting and dual antiplatelet therapy use is high, lower ACT targets, as compared with higher ACT targets, will be associated with lower rates of bleeding while having similar rates of ischemic events.

Start: February 2019

A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes

This is a Phase 2 prospective, randomized, crossover study of Flurpiridaz (18F) Injection for PET-MPI in subjects referred for evaluation of known coronary artery disease (CAD) or for suspected CAD with intermediate to high pre-test probability (PTP). The objective is to assess the difference and variability between 2 sets of rest images synthesized by the same or 2 different manufacturing processes. Twenty-eight evaluable subjects will be enrolled in this study and will undergo 2 Flurpiridaz (18F) Injection PET-MPI at rest. Each subject will attend a Screening Visit at least 2 days and up to 14 days prior to the first Flurpiridaz (18F) Injection PET-MPI. The subjects will be randomized 1:1:1:1 to 4 possible sequences of receiving 2 doses of Flurpiridaz (18F) Injection: 2 groups of 7 subjects will receive 2 Flurpiridaz (18F) Injection doses synthesized by the same manufacturing processes (either HPLC or SPE) and 2 groups of 7 subjects will receive 2 Flurpiridaz (18F) Injection doses synthesized by different manufacturing processes (1 dose by HPLC followed by 1 dose by SPE or 1 dose by SPE followed by 1 dose by HPLC). All subjects will be followed up by telephone for adverse events (AEs) and serious AEs (SAEs) at 24 (+8) hours following each Flurpiridaz (18F) Injection administration.

Start: April 2021

Real-time Automated Program for IDentification of VT Origin

RAPID-VT Pilot is a single centre prospective cohort pilot study to assess the feasibility, safety and efficacy of catheter ablation of ventricular tachycardia (VT) guided by a novel real-time software to localize the origin of VT during the ablation procedure.

Start: October 2018

Myocardial Infarction With Non-Obstructive Coronary Arteries in the Greek Population

The MINOCA-GR registry will be the first nationwide study aiming to obtain data regarding prevalence, demographics, clinical profile, previous anginal status, presence of cardiovascular risk factors, management and outcomes in patients with Myocardial Infarction with Non-Obstructive Coronary Arteries. An additional purpose of the registry is to highlight, for the first time worldwide to the best of the investigator's knowledge, the role of cardiac computed tomography angiography for risk stratification and personalized therapeutic approach in MINOCA patients.

Start: January 2021

CONNECT DES Registrty

To date, drug-eluting stents (DES) have become the standard of care in daily practice for the treatment of ischemic heart disease, by overcoming the risk of in-stent restenosis, a major issue raised in the bare-mare stents era. The application of potent anti-proliferative drugs and polymer structures that ensures sustained released of the drugs markedly reduced the neointimal hyperplasia, leading to much improved clinical outcomes compared with bare-metal stents. However, although first-generation sirolimus-eluting stents and paclitaxel-eluting stents significantly reduced the risk of in-stent restenosis and target-vessel revascularization, an augmented risk for very late stent thrombosis and fatal clinical events emerged as a new issue to be solved. Second- and newer- generation DESs adopted innovative stent platforms, novel stent materials, anti-proliferative drugs, and biocompatible polymers (including both durable and bioresorbable). Nowadays, numerous types of DESs (over 20 types) are available in clinical practice as well as bare-metal stents. However, little is known about the clinical outcome according to type of DESs in real-word practice. Given that many of recent randomized clinical trials (RCTs) demonstrate the 'non-inferiority' of brand-new DESs over older DESs in limited period time (usually for 1-year) in a selected patients eligible for RCTs, the real-world clinical outcomes according to type of DES implanted are still unveiled. Although, the question about the differential impact of generation of DES, type of biocompatible polymers (bioresorbable versus durable), thickness of stent struts and type of eluted anti-proliferative drugs are very important in clinical aspect of view, but there is little study conducted on all patients who are actually confronted in daily clinical practice. Korea operates national insurance system that covers most of the Koreans (97.1%) that are strictly monitored by National Health Insurance Service (NHIS). Of note, the claims database of NHIS of Korea contains all information including the demographic characters of patietns, diagnosis codes (ICD-9 and ICD-10), type of procedures or surgeries and the medical devices utilized, death certificates that contains type of death, and the drugs prescribe in outpatient clinic and hospitals in a individual pill level, that enables monitoring for the drug compliance. This unique feature of NHIS database allows the investigators to gain access to the dose and duration of cardio-protective medications including anti-platelet agents, lipid-lowering agents, anti-hypertensive agents, glucose-lowering agents, nitrate donors, vasodilators, and others. Given the benefits of NHIS database of Korea, we would like to establish a whole-population registry, named as COreaN NationwidE Claims daTa on Drug-Eluting Stent Registry (CONNECT DES Registry). A comprehensive analysis of this data is expected to shed new light on the impact of type of DESs and drug use in real-world practice that could be fully revealed through RCTs.

Start: August 2019

Chronic Total Occlusion Percutaneous Coronary Intervention Study

The objective of this study is to evaluate angiographic confirmation of placement of any guidewire beyond the CTO, in the true vessel lumen, in patients undergoing CTO percutaneous coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike catheter are used.

Start: May 2020

A Validation Study of Nitroglycerin Induced Acute Drop of Pd/Pa (NTG-Pd/Pa) in Clinical Practice

Hyperemia with adenosine was an elemental process in FFR examination. Adenosine injection will induce some discomfort, and increase cost expenditure. Nitroglycerine will induce an acute drop of Pd/Pa, and this lowest Pd/Pa was determined as NTG-Pd/Pa. NTG-Pd/Pa has a linear relationship with FFR value and has a good diagnostic accuracy to predict FFR?0.80 in our recent study. There is only one prospective study report on the relationship between NTG-Pd/Pa and FFR. In this study, we aim to evaluate the safety of NTG-Pd/Pa, the repeatability and dose-response of this novel index. Furthermore, we will investigate the diagnostic accuracy of NTG-Pd/Pa, with FFR?0.8 and Resting full-cycle ratio?0.89 as ischemic threshold respectively.

Start: January 2021

Preventive VT Substrate Ablation in Ischemic Heart Disease

The investigators hypothesize that preventive VT substrate ablation in patients with chronic ICM, previously selected based on imaging criteria (BZC mass) for their likely high arrhythmic risk, is safe and effective in preventing clinical VT events.

Start: June 2021

Serial Infusions of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients With Left Ventricular Assist Device

A study to assess the safety and preliminary efficacy of serial intravenous dose of Allogeneic Mesenchymal Bone Marrow Cells in subjects with heart failure and implanted left ventricular assist devices.

Start: May 2019