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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
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: 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
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: NCT05368597 Completed - Clinical trials for Coronary Artery Disease

CompArison of PCI in NaTive Arteries Versus ByPAss Grafts In PatieNts With Prior CABG (CAPTAIN)

Start date: October 1, 2019
Study type: Observational

Coronary atherosclerotic heart disease (CAD) has been considered the leading cause of death in both developed and developing countries. Coronary artery bypass grafting (CABG) is a major therapy of CAD in the world, mainly used for patients with left main disease, multi-vessel complex disease, stent implantation failure, heart failure and diabetes. Studies have demonstrated that significant angiographic defects up to 12% of grafts, which was observed by immediate coronary angiography after CABG. Despite secondary prevention were performed in patients after CABG, the early failure rate at 1 year is higher, up to 15-20%, the 10-year patency rate of internal mammary artery graft is 85%, and the 10-year patency rate of saphenous vein graft is only 61%, and 10-20% of patients require revascularization within 10 years after CABG. Patients with failed grafts usually have a higher surgical risk and the morality of repeat CABG is 2-4 times higher than primary surgery. Because of the poor clinical prognosis of patients undergoing repeat CABG, PCI is the preferred treatment strategy for revascularization in patients with previous CABG. In patients with previous CABG, approximately 75% of PCI target vessels are native vessels. Compared with native vessel PCI, bypass graft PCI has a higher rate of short- and long-term major adverse events, including more than double the in-hospital mortality rate. Some studies support the above view,but others denied. Therefore, the primary study mainly to explore the effect of native vessel PCI or graft PCI on the prognosis of patients with previous CABG.

NCT ID: NCT05361824 Completed - Clinical trials for Coronary Artery Disease

Ketorolac-an Option for Post Operative Pain Management After Elective Cardiac Surgery.

Start date: January 1, 2021
Phase: Phase 4
Study type: Interventional

OBJECTIVE: The purpose of this study was to compare the efficacy of Ketorolac versus Paracetamol as an adjunct to Nalbuphine in the management of post-operative pain following elective cardiac surgery. STUDY DESIGN: Randomized (single-blind) control trial. SAMPLING TECHNIQUE: Computer generated, randomized selection of patients with 50% probability of assignment into either group. PLACE AND STUDY DURATION: (single center) SICU at the National Institute of Cardiovascular Diseases Hospital, Karachi over a period of six months, from January 1, 2021 up to June 30, 2021. METHODS: Sixty patients (30 in each group) were randomly assigned to receive either Paracetamol (control) or Ketorolac (treatment), along with the usual Nalbuphine infusion, over the first 48 hours postoperatively. The control group received injection Paracetamol 1gm six hourly, whereas treatment group received injection Ketorolac 30mg eight hourly. PRIMARY OUTCOME: The VAS (pain score) was evaluated at 6, 12, 18 and 24 hours post-extubation and a score of 4 or less was taken as a cut-off for adequate pain control. SECONDARY OUTCOMES: The time taken to extubation postoperatively. The total dose of Nalbuphine administered to each patient and total chest tube drainage recorded over 48 hours postoperatively.

NCT ID: NCT05357937 Completed - Obesity Clinical Trials

Structured Physiotherapy Program in Obese and Non-obese Patients

Start date: December 16, 2020
Phase: N/A
Study type: Interventional

A routine physiotherapy program has been shown to be effective in the prevention and treatment of cardiopulmonary diseases. It also significantly increases functional capacity following coronary artery bypass grafting. However, the effect of a structured physiotherapy program in obese and non-obese patients has not been well explored. As such, the objective of this study is to determine the effect of a standardized physiotherapy program on pulmonary function and walking capacity in obese and non-obese patients undergoing coronary artery bypass grafting. A prospective study was conducted on 50 obese and non-obese individuals who were schedule for coronary artery bypass grafting. Their body mass index was used to separate them into two groups. Both groups followed a structured physiotherapy program from day 1 to day 7 post cardiac surgery. Both groups underwent spirometry and a six-minute walk test at baseline (preoperatively) and after day 4 and day 7 postoperatively. The effect of physiotherapy program on pulmonary function and 6-MWT was assessed using an independent t-test. To estimate the percentage increase or decrease of pulmonary function and distance during 6-MWT for obese and non-obese groups, the percent difference between baseline and posttest data was calculated and compared using an independent t-test. When the normality test failed, the Mann Whitney U test and analysis of variance on rank were used. Chi-square test was used for gender distribution. The results were considered statistically significant if p ≤ 0.05.

NCT ID: NCT05354648 Completed - Clinical trials for Coronary Artery Disease

Effects of Hypoxic-hyperoxic Preconditioning in Cardio-surgical Patients

Start date: June 1, 2015
Phase: N/A
Study type: Interventional

Coronary artery bypass grafting (CABG) with cardiopulmonary bypass is a common surgical therapy for patients suffering from coronary artery diseases. The heart is subjected to a long period of ischemia due to the occlusion of the aorta. The heavy burden of myocardial ischemia-reperfusion injury (IRI) thus induces cardiomyocyte death, which can paradoxically reduce the beneficial effect of CABG. Preconditioning by moderate hypoxia or hyperoxia serves as an effective drug-free method to increase the organism's resistance to negative effects, including IRI.

NCT ID: NCT05315544 Completed - Clinical trials for Coronary Artery Disease

Cardiovascular Systems Inc. (CSI) pVAD First in Human Study

Start date: March 14, 2022
Phase: N/A
Study type: Interventional

This study will collect initial clinical data on the CSI pVAD system to inform device design and finalization.

NCT ID: NCT05290324 Completed - Clinical trials for Coronary Artery Disease

Propofol or Midazolam for Sedation and Early Extubation Following Coronary Artery Bypass Graft Surgery

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Propofol and midazolam are used frequently as sedating agents among patients who undergo coronary artery bypass graft surgery but no study in Pakistan has been done to compare their effectiveness aiming early extubation.

NCT ID: NCT05251012 Completed - Clinical trials for Coronary Artery Disease

3D-QFR in Non-selected Angiographic Stenosis. A Spanish Multicentre Study.

Start date: January 1, 2015
Study type: Observational

Physiology-based decision-making about the need for revascularisation in patients with stable coronary heart disease has consistently proven better clinical outcomes than a merely anatomical approach. However, against the current recommendations, revascularisation in most of patients with chronic coronary syndromes still relies on coronary angiography alone. The increase in costs and in procedural complexity of wire-based physiology may explain the latter. Therefore, a novel non-invasive functional quantitative flow ratio (QFR) index was created in order to solve it. A retrospective and multicentre study is performed to assess the 5-year prognosis of patients undergoing coronary angiography through a centralized QFR analysis. Consecutive participants with confirmed or suspected diagnosis of stable coronary disease who underwent a coronary angiography between 01/01/2015 and 12/31/2015 were included. Aims of the study: - To evaluate the prognosis of stable coronary disease depending on the functional assessment of coronary artery disease. - To determine the % of percutaneous coronary interventions that could be avoided if this study had been carried out through functional assessment of coronary artery disease based on 3-dimensional vessel reconstruction.

NCT ID: NCT05247385 Completed - Clinical trials for Coronary Artery Disease

Platelet Aggregation and Adenosine Levels Among Patients Taking Ticagrelor or Prasugrel

Start date: March 20, 2017
Phase: Phase 4
Study type: Interventional

Prospective, single-center, double blind, double dummy, randomized trial. Platelet function tests and adenosine levels were assessed at baseline and 15 days after taking Ticagrelor with Prasugrel placebo or Prasugrel with Ticagrelor placebo in stable patients with coronary artery disease