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Coronary Artery Disease clinical trials

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NCT ID: NCT05387902 Completed - Clinical trials for Coronary Artery Disease

Short-term Outcomes of Elective High-risk PCI With Extracorporeal Membrane Oxygenation Support: a Single-centre Registry

Start date: February 3, 2022
Phase:
Study type: Observational [Patient Registry]

Background Revascularization of complex coronary artery disease, including multivessel coronary artery disease, left main stenosis, bifurcation stenosis and chronic total occlusions (CTO) can be performed by Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG), according to current guidelines.[1] In order to decide whether to revascularize by either CABG or PCI, patient characteristics, the presence of comorbidities, including diabetes, and coronary lesion complexity (e.g. SYNTAX) should be taken into consideration. Because of the ageing population with a higher incidence of comorbidities and higher surgical risk scores, high-risk PCI in complex coronary disease with high risk for periprocedural cardiogenic shock is increasingly performed.[2, 3] Mechanical Circulatory Support (MCS) devices for elective high-risk PCI can provide hemodynamic support, preventing hemodynamic failure during PCI. Several studies are performed using Intra-Aortic Balloon Pump (IABP) and co-axial left cardiac support device (Impella device (Abiomed, Danvers, USA)), showing no clear benefits in patients with high-risk PCI.[4-6] Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) is a recent addition to mechanical support options, providing more extensive hemodynamic support in patients with potential or ongoing failure of circulation. This concept is already demonstrated in the setting of Extracorporeal Cardiopulmonary Resuscitation (ECPR).[7, 8] ECMO has the additional benefits of right ventricular unloading and blood oxygenation as opposed to IABP and Impella.[9] Our experience with fully percutaneous VA-ECMO in cardiogenic shock and for ECPR combined with the experience for Transcatheter Aortic Valve Replacement (TAVR) with local anaesthesia and mild sedation resulted in the selection of VA-ECMO as our preferred method in high risk PCI. Studies investigating the use of VA-ECMO support during high-risk PCI are however limited.[10-13] Objective The aim of this study is to provide additional data concerning the short-term outcomes of elective high-risk PCI with VA-ECMO in a single PCI centre. Methods Design We will perform a single-centre, retrospective registry, using data collected from medical records of included patients. Inclusion criteria - Patients older than 18 years, who underwent high-risk PCI with VA-ECMO support. - The use of mechanical circulatory support (MCS) is indicated by HeartTeam based on patient and lesion characteristics described in the expert consensus on the use of MCS Devices for high-risk PCI. [14] Exclusion criteria • Non-elective PCI with VA-ECMO support, primarily applied for cardiogenic shock or ECPR. Study Procedures All patients older than 18 years who underwent high-risk PCI with VA-ECMO support will be included in the registry. Baseline patient and angiographic characteristics, ECMO characteristics and short-term outcomes, described in the paragraph 'Study Endpoints and Definitions' will be collected from medical records. The Dutch Act on Medical Research involving Human Subjects (WMO) does not apply to this study, because of the retrospective design of the study using only medical records and consequently patients are not subjected to additional procedures. Therefore, no written informed consent will be obtained from patients or legal representatives as well. Data Collection All data will be collected in a cloud-based electronic case report form (eCRF, Castor Electronic Data Capture), which will be developed and managed by investigators in the Radboudumc. Only members of the study team will have access to the patient eCRFs and will be allowed to enter data in the system. The study team exists of the investigators mentioned earlier. The study team will collect the data from medical records and enter the data in Castor. All patient data will be encoded. Only the investigators involved will have access to the patient identification key. Study Endpoints and Definitions Successful revascularization is defined as final residual stenosis <50% with a TIMI flow grade 3, achieved in at least one of the target vessels. Procedural success is defined as angiographic success without the occurrence of peri-procedural MACE, including death and myocardial infarction (MI). Additionally, MACE will be assessed during hospital stay and within 60-days follow-up after discharge and defined as a composite of death, MI, Target Vessel Revascularization (TVR) by PCI or CABG and clinical bleeding, assessed by the Bleeding Academic Research Consortium (BARC) scale. Bleeding complications of type 2 and higher are included.

NCT ID: NCT05381246 Not yet recruiting - Clinical trials for Coronary Artery Disease

The Effect of Reiki and Acupressure on Pain, Anxiety and Vital Signs

Start date: May 15, 2022
Phase: N/A
Study type: Interventional

This research aims to determine the effects of reiki and acupressure applied after percutaneous coronary intervention on pain, anxiety and vital signs during femoral catheter extraction.

NCT ID: NCT05380622 Recruiting - Clinical trials for Coronary Artery Disease

CHART Study of Coronary CT Angiography in Coronary Artery Disease

CHART-VISION
Start date: January 1, 2015
Phase:
Study type: Observational

In a cohort of patients referred to coronary computed tomography angiography (CCTA), the investigators aim: 1. To describe the natural history of the coronary atherosclerotic plaque development and progression or regression, as well as the plaque characterization and phenotypes over time by CCTA among deferred coronary lesions 2. To explore the precursors of plaques leading to acute coronary syndrome (ACS) or chronic coronary syndrome (CCS) in deferred coronary lesions 3. To investigate prognostic implication of qualitative and quantitative plaque analysis of stenosis and plaque features, disease patterns, hemodynamic parameters, and fat metrics on CCTA along with physiologic assessment 4. To investigate the effects of different treatment strategies according to stenosis and plaque features, fat metrics on CCTA along with physiologic assessments.

NCT ID: NCT05380063 Not yet recruiting - Clinical trials for Coronary Artery Disease

Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting

TOP-CABG
Start date: August 2022
Phase: Phase 4
Study type: Interventional

Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting trial (TOP-CABG trial) is a multicenter, randomized, double-blind, non-inferiority, parallel controlled trial. The first aim of TOP-CABG is to investigate, comparing to dual antiplatelet therapy (DAPT), whether de-escalated dual antiplatelet therapy (De-DAPT) is non-inferior to dual antiplatelet therapy (DAPT) in efficacy on inhibiting great saphenous vein (SVG) graft occlusion in patients accepting coronary artery bypassing grafting. The second aim is to compare the risk of bleeding events between DAPT and De-DAPT.

NCT ID: NCT05377320 Not yet recruiting - Hypertension Clinical Trials

Patient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity: A Feasibility Study

Start date: June 2022
Phase:
Study type: Observational

This is a single-center, double-arm, open-label, randomized feasibility study that will determine whether a novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists, will favorably impact appropriate medication use and cardiac imaging surveillance, and will improve clinician and patient decision-making, perception, and behavior towards cardioprotective medication usage and cardiovascular disease imaging utilization.

NCT ID: NCT05374733 Recruiting - Clinical trials for Coronary Artery Disease

Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions

POTUS
Start date: March 22, 2021
Phase: N/A
Study type: Interventional

Prospective, single-arm, observational study with invasive coronary physiology measurements before and after transcatheter left-sided valvular intervention.

NCT ID: NCT05369728 Not yet recruiting - Clinical trials for Coronary Artery Disease

Screening Of CoRonary ArTEry diSease

SOCRATES
Start date: May 2022
Phase: N/A
Study type: Interventional

This study is a randomized trial with the objective of comparing the cost-effectiveness of the 2 recommended strategies: CCTA vs functional tests, allowing the evaluation of the quality of life of these patients in relation to the health resources used. In symptomatic patients with an intermediate probability of having stable CAD, i.e., whose pretest or clinical probability does not allow the elimination of the disease, and in patients without anginal symptoms for low levels of exercise who do not respond to medical therapy, in France, the diagnostic care pathways have become mature enough to set up a pragmatic prospective randomized trial with the objective of comparing the cost-effectiveness of the 2 recommended strategies: CCTA vs. Probabilistic medico-economic reasoning makes it possible to establish this two-way hypothesis more easily than in clinical research without the need to impose the superiority of one of the strategies.

NCT ID: NCT05369702 Completed - Clinical trials for Coronary Artery Disease

Association of Coronary Artery Disease With Lewis and ABO Blood Group Phenotypes

Start date: November 1, 2019
Phase:
Study type: Observational

Primary objective- To study the association of Lewis antigen and A, B, O blood group phenotypes with coronary artery disease patients attending the tertiary care hospital in Kerala. The secondary objective-To find the association of Lewis antigen and A, B, O blood group phenotypes with smoking, alcohol use, diabetes, hypertension and dyslipidemia. A case-control study to compare the prevalence of Lewis(a-b-) blood group among confirmed cardiac cases with the prevalence of the same among the general population and thereby find out if individuals with Lewis(a-b-) are more at risk of developing coronary artery disease. This may provide an economical and simple method for identifying subjects at increased risk for coronary artery disease and subsequently lead to more focused preventive measures and eventually to a specific treatment.

NCT ID: NCT05369442 Not yet recruiting - Clinical trials for Coronary Artery Disease

Prognostic Analysis of PCI-HBR Patients and Exploration of Appropriate DAPT Strategies

Start date: May 1, 2022
Phase:
Study type: Observational [Patient Registry]

Percutaneous coronary intervention (PCI) is an important treatment strategy for patients with coronary artery disease. Combined bleeding after PCI significantly increases the risk of death in patients. The search for prognostic predictors and optimal antiplatelet therapy for patients with high bleeding risk (HBR) after PCI has been a hot topic in cardiovascular research. There is no accepted prognostic model or recommended antiplatelet therapy for patients with PCI-HBR. In this project, based on retrospective data extraction and prospective database building, we used artificial intelligence (AI) to analyze the adverse prognostic predictors of PCI-HBR patients, observe the types of antiplatelet drugs and duration of dual antiplatelet therapy in PCI-HBR patients, and compare the safety and feasibility of different antiplatelet regimens and treatment courses. The safety and feasibility of different antiplatelet regimens and regimens were compared.

NCT ID: NCT05369182 Not yet recruiting - Clinical trials for Coronary Artery Disease

Multicenter Registry of Coronary Flow-Derived Indexes (MulticenterFLOW)

Start date: May 1, 2022
Phase:
Study type: Observational

MulticenterFlow is a prospective, multi-center, registry study. The aim of the study is twofold: 1. To evaluate prognostic implications of coronary microvascular disease (CMD) in patients with ischemic heart disease (IHD) undergoing revascularization decision using fractional flow reserve (FFR) or other non-hyperemic pressure ratios in deferred population 2. To evaluate the efficacy of intravascular imaging-guided optimization to enhance post-revascularization coronary circulatory function, compared with angiography-only guided revascularization in revascularized population.