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Cardiac Disease clinical trials

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NCT ID: NCT03174106 Completed - Cardiac Disease Clinical Trials

Longterm Follow-up of Cardiac Patients With an Smartphone-Application

Start date: October 5, 2017
Phase: N/A
Study type: Interventional

Cardiovascular disease is the leading cause of morbidity and mortality globally. Cardiac rehabilitation (CR) including exercise training are effective to reduce morbidity, mortality and risk factors such as physical fitness, cholesterol, triglycerides and blood pressure. The main goal for CR is to establish exercise training and other lifestyle changes as permanent changes in the patient's life. Many studies have shown that cardiac patients strive to maintain a heart-healthy lifestyle, one year after participating in CR. Furthermore, this leads to risk profile returning to the starting point where they got their Cardiac event. Changing a lifestyle is known to take time, and we believe that the patients need further follow-up beyond the time spent in traditional CR. To our knowledge very few, if any, studies evaluates the use of modern technology in longterm follow-up focusing on maintaining a new lifestyle after participating in CR. The investigators would like to evaluate the effect of an dynamic application (app) with regard to physical fitness, lifestyle and quality of life (QoL), one year after CR. The investigators hypothesize that patients getting Access to a dynamic Application and tailored feedback through the application after CR will better be able to take care of physical Fitness and other lifestyle factors one year after CR, compared to patients getting usal care.

NCT ID: NCT03113565 Completed - Cardiac Surgery Clinical Trials

Connected Electronic Wrist Strap for Patient Follow-up After Cardiac Surgery

BECSuP
Start date: August 9, 2017
Phase:
Study type: Observational [Patient Registry]

After cardiac surgery, patients' follow-up after discharge is a major public health issue. Since the main complications occur mostly during the first extra-hospital month, a follow-up period becomes necessary as the average duration of hospitalization tends to decrease. The resumption of normal physical activity is rarely transmitted and when complications arise, the healthcare team is most often informed late. An electronic wristband is worn by the patient during the day, between the day of discharge from the hospital (D0) and the end of the second extra-hospital month (D60). The data recorded by the wristband include : bracelet ID, date, time and number of steps per day. The primary objective of the study is to measure the resumption of physical activity after elective cardiac surgery. This objective will be quantified by the number of daily footsteps. A secondary objective is to determine perioperative predictors of the physical resumption.

NCT ID: NCT03103633 Completed - Cardiac Disease Clinical Trials

The Effects of Individualized Oxygen Dynamic on Prognosis of Patients With High-risk Cardiac Surgery

Start date: March 5, 2017
Phase: N/A
Study type: Interventional

Anesthesia-related factors have been linked to poor perioperative outcomes. Our observational study suggested that the cumulative duration of a triple-low state [intraoperative low mean arterial pressure (MAP), low bispectral index (BIS), and low target effect-site concentration(Ce) ]was associated with poorer 30-day mortality.This randomized, prospective study based on individualized Oxygen dynamics is designed to confirm this association in high-risk patients cardiopulmonary bypass (CPB).

NCT ID: NCT03098524 Completed - Pneumonia Clinical Trials

Low Tidal MEChanical Ventilation Against NO Ventilation During Cardiopulmonary Bypass Heart Surgery

MECANO
Start date: May 2, 2017
Phase: N/A
Study type: Interventional

BACKGROUND. Postoperative pulmonary complications are a leading cause of morbidity and mortality after cardiac surgery. To this date, there are no recommendations regarding mechanical ventilation associated with cardiopulmonary bypass (CPB) during the surgery and anesthesiologists perform either no ventilation (noV) at all during CPB or maintain a low-tidal volume ventilation (LTV). Indirect evidence points towards better pulmonary outcomes when LTV is performed but no proper prospective trial with large inclusion of all types of cardiac surgery has been published. DESIGN. The MECANO trial is a single-center, double-blind, randomized controlled trial comparing two mechanical ventilation strategies, noV and LTV, during cardiac surgery with CPB. 1500 patients will be included for whom planned cardiac surgery with CPB is performed. They will be randomized between noV and LTV, on a 1:1 ratio. The noV group will receive no ventilation during CPB. The LTV group will receive 5 acts/minute with a tidal volume of 3 mL/kg and positive end-expiratory pressure of 5 cmH2O. Primary endpoint will be composite of overall death, early respiratory failure defined as PaO2/FiO2 ratio <200 mmHg at one-hour after arrival in the ICU, heavy oxygenation support (defined as a patient requiring either non-invasive ventilation, mechanical ventilation or high flow oxygen) at 2 days after arrival in the ICU or ventilator acquired pneumoniae defined by Center of Disease Control. Lung recruitment manoeuvers will be performed for noV and LTV groups, at the end of surgery and at the arrival in ICU with an insufflation at +30 cmH20 during 5 seconds. Secondary endpoints are those composing the primary endpoint with the addition of pneumothorax, CPB duration, quantity of postoperative bleeding, red blood cells transfusions, revision surgery requirements, length of stay in the ICU and in the hospital and total hospitalization costs. Patients will be followed until hospital discharge. SUMMARY. The MECANO trial compares a no-ventilation to a low-tidal volume strategy for mechanical ventilation during cardiac surgery with CPB, regarding a primary composite outcome including death, respiratory failure and pneumoniae.

NCT ID: NCT03045068 Completed - Cardiac Surgery Clinical Trials

Platelet Transfusion During Neonatal Open Heart Surgery

CPB
Start date: April 11, 2017
Phase: Phase 4
Study type: Interventional

Hypothesis: Dilutional thrombocytopenia after cardiopulmonary bypass (CPB) is universal and administration of donor apheresis platelets just prior to termination of bypass will assist in early correction of coagulopathy, early hemostasis and lesser donor exposure of blood products after cardiac surgery. Background: What is the Problem? - Bleeding, Transfusion and Outcomes 1. Excessive bleeding after neonatal cardiac surgery has been independently associated with increased adverse events, morbidity and mortality.1,2 Bleeding after neonatal open-heart surgery has multiple etiologies such as immaturity of the building blocks of coagulation, effects of deep hypothermia, longer CPB times, altered flow states and dilutional state induced by being on CPB leading to low platelet count, low platelet function, low fibrinogen levels, altered fibrinogen polymerization, complement activation, etc.2,3 The strongest predictor of transfusion after cardiopulmonary bypass in children was deemed to be the CPB circuit volume and the effect of hemodilution.4 2. The dilutional coagulopathy after neonatal CPB requires intense damage control resuscitation with massive transfusion of platelets, packed red blood cells (PRBC), cryoprecipitate, fresh frozen plasma (FFP) and supplemental factor concentrates. In a previous study at this institution (IRB# HSC-MS-13-0647), we have shown that in neonates undergoing open-heart surgery there was a significant drop in platelet counts after bypass (71% change, baseline= 268 ± 90, Post CPB= 76 ± 27, 109/L). Associated with this drop , the average intraoperative transfusion load in neonates undergoing cardiac surgery with CPB at our institution constitutes of PRBC= 63± 43 ml/kg, FFP=51± 21 ml/kg, cryoprecipitate =12+6 ml/kg, platelets = 28 +16 ml/kg and cell-saver =27± 10 ml/kg. In addition 72% of these patients were exposed to a 3-factor prothrombin complex concentrate (Bebulin®). Although this "throw the kitchen sink" approach is effective in achieving hemostasis, it comes with significant effects on post CPB hemodynamics, constantly changing hematocrit, variable blood volume with inability to achieve steady state inotropic state affecting cardiac output, oxygen delivery and adding to pulmonary hypertension. Overall, having higher platelet counts at the time of weaning from cardiopulmonary bypass has distinct advantages of reducing transfusions and improving outcomes.

NCT ID: NCT03016429 Completed - Cardiac Disease Clinical Trials

Safety and Clinical Outcomes of Magnetic Resonance Imaging in Patients With Cardiac Implantable Electrical Devices

BIDMC-MRI
Start date: December 2016
Phase:
Study type: Observational

This protocol outlines a prospective study evaluating safety and clinical outcomes of magnetic resonance imaging (MRI) examinations performed on patients with cardiac implantable electrical devices (CIEDs) including pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs). This prospective study aims to improve the evidence base regarding this common clinical scenario. Specifically, the investigators aim to address whether results of MRI in PM/ICD patients affect physician decision making related to clinical management strategy and planning treatment interventions. Further, this study will evaluate whether the results of MRI in these patients affects patient outcomes related to survival and adverse events during or after MRI scanning.

NCT ID: NCT02996903 Completed - Clinical trials for Coronary Artery Disease

Prospective Multicenter Registry On RadiaTion Dose Estimates Of Cardiac CT AngIOgraphy IN Daily Practice in 2017

PROTECTION-VI
Start date: March 1, 2017
Phase:
Study type: Observational [Patient Registry]

The "Prospective Multicenter Registry On RadiaTion Dose Estimates Of Cardiac CT AngIOgraphy IN Daily Practice in 2017" (PROTECTION-VI) study is a prospective registry and investigator-initiated initiative without third-party funding, which will collect and analyze the radiation dose exposure of Cardiac Computed Tomography Angiographic (CCTA) studies in current daily practice worldwide. Particularly, the study will assess the use of strategies for dose reduction during CCTA. A decade ago, the multicentre observational PROTECTION-I study has revealed that the dose-length-product of CCTA ranges between 568 - 1259 mGy x cm with a median of 885 mGy x cm. This corresponds to an estimated effective dose of approximately 12 mSv. Since then a variety of techniques have been developed and enhanced in order to reduce radiation exposure during CCTA. Recent studies demonstrated feasibility of dramatically reduced effective radiation doses during CCTA (0,1 - 0,3 mSv). This has been executed in small cohorts of patients at scientific expert centers. However, it remains unclear, if such low-level radiation dose exposure may be achieved in clinical routine and if diagnostic image quality is maintained. In order to analyze the magnitude of radiation dose exposure of CCTA in today's clinical practice and the current use of dose-saving techniques, we designed the PROTECTION-VI study. Eventually, this study may contribute to further improving radiation dose exposure for patients undergoing CCTA.

NCT ID: NCT02976584 Completed - Epilepsy Clinical Trials

Epileptic Potentials During Cardiac Surgery and Association With Postoperative Neurological Outcome

EPOCAS
Start date: July 11, 2016
Phase:
Study type: Observational

Primarily, the investigators want to test the hypothesis that it is possible to detect epileptiform EEG during cardiac surgery under general anesthesia. Furthermore, the investigators will examine if those epileptic potentials coincide, follow or are unrelated to ischemic events detected by EEG or Near-infrared spectroscopy (NIRS). Finally, the investigators will look for independent associations between intraoperative seizures (with or without ischemic events) and postoperative neurological outcome, as well as between intraoperative seizures (with or without ischemic events) and the total amount of TXA given.

NCT ID: NCT02976415 Completed - Critical Illness Clinical Trials

In-Bed Cycling in ICU Patients Post Cardiac Surgery

CardiO Cycle
Start date: August 28, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if in-bed cycling is safe and feasible in critically-ill patients after open heart surgery. The investigators hypothesize that in-bed cycling can be safely used with this population and that it is feasible to use in a fast-paced cardiac intensive care unit.

NCT ID: NCT02954861 Completed - Delirium Clinical Trials

A Study to Identify the Incidence of Post Traumatic Stress Symptoms in Patients With Delirium Following Cardiac Surgery

Start date: April 7, 2016
Phase:
Study type: Observational

'Post perfusion syndrome' was a term historically associated to cardiac surgery in view of the transient neuro-cognitive deficits attributed to cardio pulmonary bypass pump. During their recovery period, a significant number of patients experience delirium, a clinical syndrome of acute onset and fluctuant course.Though these deficits are often known to be transient without any permanent physical or neurological impairment, the experience can still psycho-socially affect these patients for a longer length of time even after discharge. The presence of delirium puts excessive, undesired strain on the patient, their families, health care providers and hospital resources. PTSS is an anxiety disorder caused by very stressful, frightening or distressing events. It is known to either develop immediately after the disturbing event or weeks and months later. The actual symptoms can be varied but are categorized in three sections: i.e.: re-experiencing, avoidance and emotional numbing and hyperarousal (feeling 'on edge'). A problem that has such an impact on any patient is worth investigating and understood better. Being in such a unique professional position, as a Clinical nurse practitioner, the investigator is ideally placed to conduct this study. In this study, the researcher will be focusing on the pre-operative risk factors in developing delirium, actual incidence of delirium and follow the patients post operatively to evaluate the after effects of delirium in the form of PTSS.