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60 active trials for Coronary Disease

Myocardial Perfusion, Coronary Flow Reserve and Kinetic Analysis During Dobutamine Stress Echocardiography

Stress echocardiography is a screening test for coronary heart disease that already has good sensitivity and specificity (both around 70%). This examination is mainly offered to stable patients, consulting externally, in order to detect ischemic heart disease in the same way as would a myocardial scintigraphy or MRI stress. This examination is an echocardiographic modality consisting in visualizing and analyzing the modifications of the contraction of the cardiac muscle during a stress constituted by an effort or by injection of certain drugs. Stress echocardiography is performed by injection of drugs to reproduce the conditions of the effort. The products used to perform this examination are initially an intravenous infusion of dobutamine, atropine whose effect is to increase the heart rate, and in a second time, an intravenous infusion of beta-blockers or a bradycardic calcium channel blocker at the end of the procedure whose effect is to slow down the heart rate. The use of echographic contrast medium, allowing a better visibility, is recommended for the realization of a stress ultrasound, since the echogenicity is judged insufficient on two segments (segmentation of the left ventricle in 17 segments). The analysis of dobutamine stress echocardiography currently relies solely on the analysis of segmental kinetics, namely the quality of the thickening of the endocardium. When segmental kinetics are abnormal, patients benefit from a coronary CT scan or coronary angiography to visualize all the coronary arteries and to check whether there is a narrowing of the arteries. Moreover, stress echocardiography performed using a contrast medium makes it possible to analyze two other indices in addition to segmental kinetics. Thus, the second parameter that can be analyzed corresponds to the Coronary Flow Reserve measurement, thanks to the easy identification of the Doppler flow in the anterior interventricular at rest and peak of dobutamine. The coronal reserve is well validated with adenosine, but much less well known under dobutamine. The third parameter that can be analyzed is myocardial perfusion. By using appropriate settings, it is possible to see the microbubbles in the thickness of the myocardium. These bubbles are then destroyed by an ultrasonic flash of high mechanical index. This results in the destruction of all intra-myocardial bubbles. The analysis of the myocardial perfusion is based on the rate of reappearance of these bubbles (through the coronary arteries) at rest and peak stress. In case of significant stenosis or coronary occlusion, there is a delay or complete absence of perfusion in the territory concerned. Joint analysis of segmental kinetics, coronary reserve and myocardial perfusion has already been described with adenosine, but not with dobutamine. Studies in the literature suggest that the analysis of coronary reserve on the one hand, and myocardial perfusion on the other hand would increase the sensitivity and specificity of the examination. In addition, other studies suggest that among the tests considered normal for segmental kinetics analysis, there are patients with myocardial perfusion abnormality and / or coronary reserve abnormality that strike (s) on prognosis (alteration of the coronary microcirculation). This is why it seems interesting to compare the results of these 3 indices obtained during stress echocardiography under dobutamine.

Start: June 2019

Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Routine Clinical Practice

The purpose of this study is to evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold compared to other (drug eluting stents) DES.

Start: February 2016

Keep bIfurcation Single Stenting Simple

KISS study is an investigator-initiated, multi-centre, prospective, randomized (1:1), parallel, two-arm, non-inferiority trial aiming to compare two bifurcation PCI procedures for Side Branch protection

Start: July 2020

HIV-HEART Aging Study (15 Year Follow up)

The HIV/HEART Aging study (HIVH) is an ongoing, prospective, multicentre trial that was conducted to assess the incidence, the prevalence and the clinical course of cardiovascular diseases (CVD) in HIV-infected patients. The study population includes outpatients from specialized HIV-care units of the German Ruhr region, who were at least 18 years of age, were known to have a HIV-infection and exhibited a stable disease status within 4 weeks before inclusion into the trial. From March 2004 (Pilot phase) to October 2022 (15 year Follow-up) 1806 HIV+ patients were recruited in a consecutive manner. The standardised examinations included a targeted assessment of medical history and physical examination. Blood was drawn for comprehensive laboratory tests including HIV specific parameters (CD4 cell count, HIV-1 RNA levels) and cardiovascular items (lipid concentrations, BNP values and renal parameters). Furthermore, non-invasive tests were performed during the initial visit, including additional heart rate and blood pressure measurements, electrocardiogram (ECGs) and transthoracic echocardiography (TTE). Examinations were completed in accordance with previously defined standard operating procedures. CVD were defined as coronary, cerebrovascular, peripheral arterial disease, heart failure or cardiac vitium.

Start: May 2020

IRIS- DESyne X2 in the IRIS-DES Registry

This study evaluates effectiveness and safety of DESyne X2 in Routine Clinical Practice.

Start: November 2018

The Usefulness of Coronary CT Scan After Everolimus-eluting Bioabsorbable Scaffold Implantation for Coronary Artery Disease

The purpose of this study is to evaluate usefulness of coronary computed tomographic scan for prediction of clinical events after everolimus-eluting bioabsorbable scaffold implantation for coronary artery disease.

Start: June 2021

Triple or Dual Antithrombotic Therapy After PCI (TRIDUAL-PCI) Coronary Intervention in Patients With Non-valvular Atrial Fibrillation. Real-world Italian Multicenter Registry (TRIDUAL-PCI)

Aim of this study is to describe clinical and procedural characteristics of real-world population initiated on triple antithrombotic therapy (double antiplatelet therapy+anticoagulant) or double antithrombotic therapy (single antiplatelet therapy+anticoagulant) after percutaneous coronary intervention (PCI). Investigator's driven trial, retrospective (2015-2019), multicenter Italian registry. Baseline clinical characteristics as well as procedural details will be collected retrospectively. Follow-up data (minimum 6 months and maximum 5 years follow-up) will focus on combined rates of stent thrombosis and myocardial infarction (primary endpoint).

Start: January 2020

PCI Suite: Road Map Fusion Imaging in Coronary Diagnostics and Therapy

The PCI Suite is developed by Philips Medical Systems, a Philips Healthcare company. The proposed PCI Suite is a new software package which can be used during coronary interventions. The software package includes two sub-packages, known as StentBoost and Cardiac Roadmapping. The patient will undergo standard of care medical treatment for his or her cardiac condition. During the procedure, the physician may make angiograms for diagnosis and as reference for device navigation as part of the standard care. These angiograms will be automatically processed in PCI Suite and displayed on fluoroscopy for navigation support. In case a balloon catheter is inserted into the coronary arteries, the physician may take cine images as part of the standard care. These images can be automatically enhanced in PCI Suite. The primary objective of this prospective, mono-center, randomized clinical trial is to evaluate the amount of contrast medium used during percutaneous coronary intervention.

Start: April 2017

in Patients With SCAD Undergoing Complex PCI, the RESPONSE Study"

Evaluation of Efficacy/Safety in Cangrelor use in patients with SCAD undergoing complex PCI. Prospective, observational, multicenter registry.

Start: February 2020

Distal vs Proximal Radial Approach for Coronary Interventions

The distal radial approach ('snuff box' / fossa radialis) has become as valuable as the 'classical' radial approach for coronary angiography and interventions. Up to now, the success of the procedures has been described in several papers, with no difference in the complication rate and characteristics of the coronarography compared to the radial approach. It was observed that patients using distal radial access had fewer postoperative radial artery occlusions. This study will compare the characteristics of coronary angiography / percutaneous coronary intervention (duration of procedure, time to obtain the vascular arterial access, amount of contrast used, time and amount of radiation, success of procedure) and patency of radial arteries 3 months after the intervention using the distal ('snuff box') and proximal ('classic') radial approach

Start: February 2020

A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease

The purpose of this study is to determine whether Fractional flow reserve (FFR, (coronary pressure wire-based index for assessing the ischemic potential of a coronary lesion)-guided percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease (CAD) will result in similar outcomes to coronary artery bypass graft surgery (CABG).

Start: August 2014

T1-mapping by Cardiovascular Magnetic Resonance Imaging to Assess Non-Alcoholic Fatty Liver Disease

On clinically indicated Cardiovascular Magnetic Resonance studies, native T1-times and extracellular volume of the liver will be assessed and findings correlated with established risk calculators for non-alcoholic fatty liver disease.

Start: June 2020

Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice

The objective of this study is to evaluate effectiveness and safety of Xience Sierra stent in the "real world" daily practice as compared with other drug-eluting stents.

Start: December 2019

To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization

To evaluate The Safety and Efficacy of 'AVI' Stent Comparing with Firebird2® For Treating Coronary Revascularization.

Start: August 2013

Intervention in Lifestyle and Therapeutic Adherence After Coronary Event Based on Web Application

Ischemic heart disease is the most frequent cause of mortality in the surrounding countries. Once a coronary event is over, there is a high risk of readmission, recurrence and, mortality, attributed to a sub-optimal control of cardiovascular risk factors (CVRF), highlighting the need to improve secondary prevention strategies aimed at changing lifestyle and therapeutic adherence. Preventive measures should be initiated during hospitalization as recommended by the clinical guidelines. The objective of this study is to evaluate, through a randomized controlled clinical trial, the effect of an intervention based on a web application of health (e-Health) on lifestyle (diet, physical activity and tobacco consumption) and medication adherence in people with coronary heart disease after percutaneous coronary intervention. The sample will consist of 240 participants, 120 in the intervention group and 120 in the usual care group that will be evaluated at the beginning and nine months after hospital discharge regarding sociodemographic, clinical, CVRF, lifestyle and therapeutic adherence characteristics. The educational intervention, monitoring and self-monitoring will be carried out using a web-based e-Health tool, mobile phone application. The quantitative primary results will be compared between the two groups using ANCOVA adjusting for age and sex. Multivariate analysis will be carried out to examine the association of the intervention with life habits, control of CVRF, as well as with the evolution after discharge in respect of cardiovascular events, emergency and re-entry views.

Start: November 2019

Fastigial Nucleus Stimulation for Coronary Heart Disease

To observe the effects of fastigial nucleus stimulation on serum inflammation, oxidative stress related factors, cardiac autonomic function and prognosis in patients with coronary heart disease

Start: January 2019

Comparison Between Optimal Coherence Tomography Guidance and Angiography Guidance in Percutaneous Coronary Intervention

The present study aims to demonstrate the superiority of optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) compared with Angiography-guided PCI.

Start: April 2017

Quantitative Measurement of Myocardial Perfusion by Cardiac CT in Patients

It is a common understanding that patients with coronary heart disease are suffering, among others, from reduced myocardial perfusion. In order to increase (normalize) the reduced perfusion, when a conventional approach failed, coronary bypass surgery, coronary vessel dilatation or stenting are performed. The similar situation with reduced myocardial perfusion may be found in patients with stenosis of the aortic valve, where aortic valve replacement may increase myocardial perfusion by left-ventricular remodelling. However, there is presently no method established to measure myocardial perfusion quantitatively and noninvasively before and after a therapeutic intervention. Data of pre- and post-therapeutic myocardial perfusion, quantitatively measured in ml/100g/min would strengthen the indication for specific therapeutic approach and enable an objective control of effectiveness of the applied therapy. Hypothesis: There is a measureable difference in quantitative myocardial perfusion values before (lower) and after (higher) interventional or surgical procedure. The goal of the study is to measure myocardial perfusion by advanced CT technology (e.g. iCT 256 Brilliance ) quantitatively in ml/100g/min in three groups of patients: Before and after coronary bypass surgery Before and after coronary vessel dilatation/stenting Before and after aortic valve replacement. The investigators will not assign specific interventions to the subjects of these three groups. Therefore, the research is strictly observational. Design: Prospective study to measure quantitatively myocardial perfusion in the above mentioned three groups of patients with simultaneous control and registration of all essential, physiological determinants of myocardial perfusion immediately prior to each CT study. The CT myocardial perfusion measurements will be performed directly after the indication for intervention or surgery and on the last day before discharge from hospital. All the collected data (determinants) inclusively the CT-studies will be anonymised and archived on a local server. The investigators of the University of Medical Computed Sciences and Technology, Innsbruck / Austria will perform the evaluation of the myocardial perfusion measurements and all statistical analysis independently of the CT-studies performing physicians.

Start: February 2015

Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial

The purpose of this study is to evaluate safety and effectiveness of CTP(computed tomography perfusion) guided revascularization vs FFR(Fractional flow reserve) guided revascularization

Start: August 2014

Coronary Revascularisation by rePOT

The presence of a coronary bifurcation complicates percutaneous revascularization. Bifurcation stenting needs to take into account the difference of diameter between proximal and distal vessels and the necessity to limit the side branch obstruction. Provisional stenting techniques with balloon juxtaposition as Kissing Balloon Inflation (KBI) fail to demonstrate a clinical benefits. This is probably explain by the detrimental effect during these technics on the proximal segment with an arterial overstretch. A new sequential technique, named rePOT, demonstrated experimentally a mechanical superiority compared to juxtaposition balloon techniques included KBI. RePOT associates an initial proximal optimizing technique (POT), a side branch inflation and a final POT. A first clinical study (n=106 patients) confirmed these excellent mechanical results with serial OCT analysis and demonstrated an excellent short term safety. Since 2017, rePOT is recommended in Europe in clinical practice. This large registry is dedicated to confirm the clinical benefits at long term after bifurcation revascularization with rePOT technique before a large randomise trial.

Start: June 2018