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NCT ID: NCT04581668 Recruiting - Clinical trials for Heart Defects, Congenital

Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease

Start date: October 5, 2020
Phase: N/A
Study type: Interventional

Positive intra-thoracic pressures induced by mechanical ventilation can negatively impact right heart hemodynamics by restricting systemic venous return and increasing right ventricular afterload. These consequences may be detrimental in patients with a restrictive right ventricular physiology and in patients with single ventricle physiology. NAVA (Neurally Adjusted Ventilatory Assist) ventilation decreases intra thoracic pressures compared to conventional ventilation modes. Brain perfusion is both a hemodynamic indicator and a prognostic factor in cardiac postoperative care. Diffuse Correlation Spectroscopy (DCS) coupled with Near Infrared Spectroscopy (NIRS) is a new technology that allows monitoring, in addition to brain tissue oxygenation, changes in brain blood flow. This physiological study aims to evaluate the impact of NAVA mode ventilation on cerebral and systemic hemodynamics in post-operative cardiac surgery patients with preload dependant right ventricle or with passive venous return to the lungs . This prospective cross-over study will include 30 patients. Once stabilized in intensive care, patients will undergo 2 periods of ventilation in NAVA mode and conventional mode separated by a 30-minute washout period, in a random order. For each period the following information will be collected: changes in cerebral blood flow and cerebral oxygenation, hemodynamic parameters including cardiac output and oxygen transport and ventilatory parameters.

NCT ID: NCT04581252 Not yet recruiting - Heart Failure Clinical Trials

Heart Failure HemOdynamic Prognostic Evaluation and OutcomE (HF-HOPE) Study

HF-HOPE
Start date: November 1, 2020
Phase:
Study type: Observational

Summary of the HF-HOPE study: Background and existing knowledge gap: As per the Canadian Chronic Disease Surveillance System, about 1 in 12 Canadian adults aged ≥20 live with diagnosed heart disease. Every hour, about 12 Canadian adults aged ≥20 die due to heart failure (HF). It is estimated that HF results in direct costs of more than $2.8 billion per year in Canada alone. As per the Canadian Society of Cardiology, heart failure is defined as "a complex clinical syndrome in which abnormal heart function results in, or increases the subsequent risk of, clinical symptoms and signs of reduced cardiac output and/or pulmonary or systemic congestion at rest or with stress". Although HF is defined as "reduced cardiac output state" no objective parameters are set to define the condition. Invasive monitoring is routinely used in hemodynamic evaluation of critically ill patients admitted in the hospital, however, there is no reliable tool available to measure hemodynamic parameters that may predict, immediate or long-term, risk of worst health outcomes in stable HF patients. We hypothesize that non-invasive bioimpedance-based hemodynamic parameters can be used as a predictive tool for health outcomes in patients with HF. To ascertain this, we propose the first of its kind HF-HOPE study. Objectives of HF-HOPE study are to 1) characterize hemodynamic measures of resting versus post-exercise (mounted ergometer) in patients with all-comer stable HF subjects, irrespective of their HF etiology using Non-Invasive Cardiac System (NICaS); 2) correlate NICaS-derived hemodynamic parameters to identify, early- and long-term risk of worse health outcomes (unplanned hospital admission due to HF or arrhythmias; listing for heart transplantation/palliative care; and death); 3) correlate the lean body mass (muscle and skeleton) with their body mass index (kg/m2) and the risk of worse health outcomes; and 4) Nested cohort study: identify the outcome-associated biomarkers of chronic HF by employing a non-targeted metabolomics/lipidomics approach. Methods: The HF-HOPE is a single center, prospective, double-blind, pragmatic clinical study. It will be conducted at St. Boniface general hospital, Manitoba's tertiary cardiac center. Patients aged ≥18 years, irrespective of any sex or gender, with confirmed diagnosis of HF will be enrolled in the study. Hemodynamic measurements (stroke volume, cardiac output, cardiac index, total peripheral vascular resistance, and cardiac power index) will be assessed using NICaS at 3-times (at rest in supine, siting position as well as after exercise on a mounted ergometer) at baseline and 6 months (±1 month) in each enrolled participant. Patients will be followed to record health outcomes as outlined above, each year. The BodPod, air displacement plathysmography device will be used to determine body compositions at baseline and 6-month. Baseline demographic data will be gathered. To optimize the use of clinical resources, we will collect blood and urine samples for non-selective metabolomics and lipidomics profiling by adopting -omics approach as a nested cohort study. Statistical analysis: Assuming the 8 to 12% 1-year mortality rate following admission with HF, a projected sample size of 500 would be suffice. Conservatively 4 covariates will be included in multivariable statistical models, while testing the independent effect of the relevant NICaS parameters of interest. We will perform subgroup analysis using age, sex, ethnicity, concomitant disease conditions, medications, and lean body mass. Anticipated outcomes and future implications: The HF-HOPE study is the first of its kind study employing non-invasive hemodynamic parameters to predict worsening health outcomes over time in HF patients. The successful outcomes will provide a promising cost effective, rapid, and reliable tool to predict worsening health outcomes before it actually lead to hospitalization, tissue damage or death. This early warnings will provide adequate time for appropriate intervention. The HF- HOPE study has been meticulously designed to replicate the pragmatic conditions while assessing the non-invasive hemodynamic measurements to widen the knowledge translation of outcomes to change the clinical practice of HF patient management. Further, this may provide supporting data for future randomized trial to replace the costly, resource-intense, and complex invasive tool to determine hemodynamic measurements in HF patients.

NCT ID: NCT04581213 Completed - Children, Only Clinical Trials

Effect of Anesthesia Induction on Cerebral Hemodynamic in Children

PEDICACHE
Start date: August 24, 2020
Phase:
Study type: Observational

General anesthesia induces hemodynamic changes, notably a reduction of arterial blood pressure going up to 30%, that may impact cerebral perfusion and oxygenation.The purpose of this study is to assess the impact of anesthesia on the cerebral oxygenation, the perfusion of the brain (assessed with transcranial doppler), and the depth of anesthesia in children between 6 months and 5 years old during the induction of general anesthesia (induced with sevoflurane and/or IV agents). It is expected that the cerebral hemodynamic will be maintained despite systemic variations.

NCT ID: NCT04581005 Recruiting - Esophageal Cancer Clinical Trials

Prehabilitation in Esophageal Cancer Care

Start date: August 19, 2019
Phase: N/A
Study type: Interventional

Prehabilitation utilizes the preoperative period to prevent or attenuate the treatment-related functional decline and its consequences. This project aims at testing feasibility and effectiveness of multimodal prehabilitation in esophageal cancer care.

NCT ID: NCT04580940 Completed - Pancreatic Diseases Clinical Trials

SpyGlass™ Discover Percutaneous

Start date: July 27, 2021
Phase:
Study type: Observational [Patient Registry]

To document the clinical utility of percutaneous cholangiopancreatoscopy using a thin, disposable, flexible endoscope for evaluation and treatment of complex pancreaticobiliary disease in a prospective, multi-center case series

NCT ID: NCT04580927 Active, not recruiting - Breastfeeding Clinical Trials

Breastfeeding and Postpartum Cardiovascular Health

sheMATTERS
Start date: March 15, 2021
Phase: N/A
Study type: Interventional

Hypertensive disorders of pregnancy (HDP) are increasingly recognized sex-specific risk factors for premature cardiovascular disease (CVD) in women. HDP, including preeclampsia and gestational hypertension, confer a 2- to 3-fold increase in the risk of chronic hypertension and ischemic heart disease 10-15 years after delivery. Observational data suggest that breastfeeding can lower maternal blood pressure (BP), risk of metabolic syndrome, and other markers of cardiovascular risk in the short term and long term, possibly by helping to re-set the metabolic changes of pregnancy. The investigators recently demonstrated an 11% reduction in the risk of metabolic syndrome among postpartum women with a variety of complications in pregnancy, including HDP, who breastfed for > 6 months, compared to those who did not breastfeed and those who breastfed for shorter durations. An analysis of 622 postpartum women at Kingston General Hospital showed that breastfeeding women had nearly a 6-mmHg lower systolic BP than women who did not breastfeed with an apparent dose-response effect of breastfeeding duration. Women with pregnancy complications including HDP are vulnerable to early weaning. Interactive, multi-modal approaches targeting a mother's breastfeeding self-efficacy (i.e., confidence about breastfeeding) have been effective in healthy postpartum women. However, these have not yet been tested specifically in HDP women, who stand to derive substantial benefit from breastfeeding. This is an important area to study since nurse-led breastfeeding supportive interventions can be widely applied to the postpartum care of women with HDP and can be integrated into comprehensive CVD risk reduction programs for these women. The primary outcome is postpartum BP, since hypertension is a key mediating factor in women's heart health. The investigators conducted a feasibility study of a breastfeeding self-efficacy intervention to enhance breastfeeding outcomes among women with HDP achieving pre-defined targets of a recruitment rate of >50% , attrition rates of < 30%, and > 70% participant satisfaction with the intervention, measured at the 6-month time point. Additionally, data showed trends in both systolic and diastolic BP favoring the intervention group. The current study is a multi-site open-label randomized trial to assess for a difference in blood pressure and breastfeeding between groups, and to serve as a cohort of HDP women for longitudinal follow-up.

NCT ID: NCT04580914 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation

NEwTON AF
Start date: April 12, 2021
Phase: N/A
Study type: Interventional

The NEwTON AF study is a multi-center, global, prospective, single arm study to establish the safety and effectiveness of the IntellaNav StablePoint Catheter and Force-Sensing System in subjects with symptomatic, drug refractory, recurrent paroxysmal atrial fibrillation.

NCT ID: NCT04580901 Recruiting - Clinical trials for Postpartum Depression

IPT-G for Mums With Postpartum Depression

OPTIMUM
Start date: December 21, 2020
Phase: N/A
Study type: Interventional

Postpartum depression is a very common and costly illness with numerous, long-term deleterious effects for women, their offspring and families; yet most women are not treated. Group IPT delivered virtually offers women a 1st-line, low-cost intervention that overcomes existing treatment barriers. To test its acceptability and effectiveness, a RCT will be conducted to compare virtually delivered group IPT immediately to usual care in women in Ontario Canada who have postpartum depression.

NCT ID: NCT04580823 Completed - Healthy Clinical Trials

Heart and Kidney Ketones Metabolism

Start date: October 15, 2020
Phase: N/A
Study type: Interventional

Participants will undergo 3 Positron Emission Tomography (PET) scans in 3 different conditions : 1. Fasting without exogenous ketone salt 2. Fasting with exogenous ketone salt supplement 3. Post-Prandial with exogenous ketone salt supplement.

NCT ID: NCT04580238 Withdrawn - Hemorrhagic Stroke Clinical Trials

Onabotulinum Toxin A (Botox) for the Treatment of Persistent Post-Stroke and Vascular Headache

Start date: December 2023
Phase: Phase 1
Study type: Interventional

Post stroke headache occurs in approximately 10-23% of all stroke patients. Its onset is shortly after experiencing a stroke, or stroke like event, and persists for at least three months. These headaches have features which resemble migraine or occur in people who have a previous history of migraine that was once infrequent. Botox is a treatment that is currently approved for the treatment of chronic migraine, that is migraine headaches occurring for at least 15 days a month for at least 3 months. Given the clinical similarity in character and frequency of post stroke headache and migraine, and the fact that stroke affects structures like the blood vessels in the brain that are also affected in migraine, this study is to investigate the possible role that Botox would have in the treatment of Post-Stroke Headache.