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Heart Diseases clinical trials

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NCT ID: NCT05317962 Completed - Covid-19 Clinical Trials

COVID-19 Echo Study

Start date: May 12, 2020
Phase:
Study type: Observational

Investigation of the cardiac manifestations of COVID-19 in patients admitted to hospital

NCT ID: NCT05312177 Completed - Clinical trials for Congenital Heart Disease

Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)

CHILD-DS
Start date: May 1, 2022
Phase:
Study type: Observational

The study objective is to compare neurodevelopmental (ND) and behavioral outcomes between children with Down syndrome (DS) who had complete atrioventricular septal defect (CAVSD) repair and children from the same clinical sites with DS without major congenital heart disease (CHD) requiring previous or planned CHD surgery.

NCT ID: NCT05300802 Completed - Clinical trials for Cardiopulmonary Bypass

The Role of Dexmedetomidine As Myocardial Protection In Pediatric Cyanotic Congenital Heart Disease Undergoing Open Cardiac Surgery Using Cardiopulmonary Bypass Machine: A Preliminary Study

Start date: December 16, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Congenital Heart Diseases (CHD) are one of the most common congenital anomalies. Worldwide, 8 to 9 out of 1000 of children are born with a CHD, of which 25 percent of are cyanotic CHD. In Indonesia, the prevalence is 43.200 out of 4.8 million births annually. The morbidity and mortality of cyanotic CHDs in the National Cardiovascular Center Harapan Kita (NCCHK) are higher than acyanotic CHDs. Open-heart surgery using a cardiopulmonary bypass (CPB) machine temporarily takes over the function of the heart and lung during surgery. However, the use of CPB has several negative effects such myocardial injury, systemic inflammation, and reperfusion injury. Preoperative hypoxia in cyanotic CHD tends to be associated with a higher risk of myocardial injury. Myocardial protection has an important role in attenuating those effects. Generally, we use a cardioplegia solution as myocardial protection, but there are several non-cardioplegia techniques that can be used to enhance myocardial protection during cardiac bypass, such as adding an anesthetic agent. Dexmedetomidine (DEX) is the active dextroisomer of medetomidine, a selective α-2 adrenergic, which has major effects including hypnosis, sedation, and analgesia as well as cardiovascular effects. The sedation is induced by stimulating the α-2 adrenergic receptor in the locus coeruleus (LC) in the pons cerebri. DEX also increases the level of GABA and Galanin and reduces endogenous norepinephrine. The lower level of endogenous norepinephrine decreases the afterload of the ventricles, increases cardiac output, and reduces myocardial injury as a result. Furthermore, the peripheral effects of DEX can reduce myocardial ischemia-reperfusion (MIR) by inhibiting NF-кB pathway activation and reducing the number of proinflammatory cytokines released. Research related to the priming and infusion of DEX during CPB in patients with cyanotic CHDs who are undergoing open-heart surgery is less reported. The aims of this study are to determine the effectiveness of the priming and infusion of DEX during CPB as myocardial protection by using two different doses compared to the control group. The population included in this study is pediatric patients with cyanotic CHD who are undergoing open-heart surgery using CPB and who classified as 6 to 9 in the Aristotle Score.

NCT ID: NCT05292144 Completed - Clinical trials for Ischemic Heart Disease

Xperience Pro PMCF Study

rEPIC04A
Start date: October 26, 2022
Phase:
Study type: Observational

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Xperience Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Xperience Pro .

NCT ID: NCT05292105 Completed - Clinical trials for Ischemic Heart Disease

NC Xperience PMCF Study( rEPIC04B)

rEPIC04B
Start date: September 26, 2022
Phase:
Study type: Observational

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of NC Xperience to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with NC Xperience .

NCT ID: NCT05284500 Completed - Clinical trials for Cardiac Surgical Procedures

Predictive Pre and Peroperative Factors for MODS-2 in Pediatric Cardiac Surgery

FPMODS2
Start date: March 18, 2022
Phase:
Study type: Observational

Pediatric cardiac surgery has a relatively high morbi-mortality. Despite great advances in surgical techniques, today the mortality rate is about 3% and morbidity is about 30-40%. Outcome has been related to demographic factors, like age; peroperative factors, like duration of cardiopulmonary bypass as well as postoperative factors like positive fluid balance. Willems et al defined a new score (MODS2), an outcome score combining either patient's death or a high postoperative morbidity. This morbidity is defined as minimum of 2 organ failures: either respiratory insufficiency, prolonged use of inotropic agents or renal insufficiency. The aim of this study is to identify pre and peroperative factors which are predictors of MODS2. Patients operated between 2008 and 2018 for pediatric cardiac surgery with cardiopulmonary bypass will be included. Variables extracted from our database will be: sex, ASA score, cyanotic cardiac pathology, redo surgery, RACH1 score, use of antifibrinolytic agents, aortic cross-clamping, deep hypothermic circulatory arrest, selective cerebral perfusion, red cell transfusion in the operating room, administration of fresh frozen plasma in the operating room, age, preoperative weight, weight difference between preop weight and weight at postop day 2, emergency surgery, duration of aortic cross clamping, duration of selective cerebral perfusion, duration of cardiopulmonary bypass, duration off deep hypothermic circulatory arrest, duration of surgery, minimal core temperature, cardiopulmonary priming volume, calculated hemodilution, use of red blood cells in the cardiopulmonary bypass priming, preoperative hemoglobin, preoperative hematocrit, preoperative platelet count, preop international normalized ratio, preop fibrinogen, preop creatinin, toal fluid balance, blood loss during surgery. A statistical analysis (see detailed description) will be used to establish a prediction model for MODS2. The variables describing best the MODS2 outcome will be retained.

NCT ID: NCT05278819 Completed - Heart Diseases Clinical Trials

Upper Extremity Elevation and Lungfunction After Open Heart Surgery

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to assess if arm elevation, with or without simultaneous deep breathing, affects oxygen saturation and lung function on patients two to four days after open heart surgery.

NCT ID: NCT05276999 Completed - Clinical trials for Rheumatic Heart Disease

Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"

Start date: January 31, 2022
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine the impact of a pragmatic RHD primary prevention program in Uganda. The secondary Objective are as follow: 1. To improve guideline-based care for sore throat through frontline healthcare provider education on clinical decision rules and guideline-based primary prevention. 2. To increase health seeking behavior for sore throat thorough a multifaceted community awareness campaign.

NCT ID: NCT05271591 Completed - Clinical trials for Cardiovascular Diseases

Generalizability of REDUCE-IT Results to People of South Asian Descent With Atherosclerotic Cardiovascular Disease in Canada (REDUCE-IT Canada SA)

Start date: March 5, 2022
Phase:
Study type: Observational

The REDUCE-IT Canada SA Study is a cross-sectional study aiming to determine the proportion of study participants who meet the Health Canada-approved indication for icosapent ethyl (IPE;Vascepa®).

NCT ID: NCT05265585 Completed - Cardiac Disease Clinical Trials

Validation of an Artificial Intelligence Algorithm Identifying Echocardiographic Reference Views. Ultrasound - Cardiac Acquisition Guide

U-CAG
Start date: June 19, 2020
Phase:
Study type: Observational

Echocardiography is the examination of choice for the study of cardiac pathologies. Beyond its use by cardiologists, the interest of echocardiography for other medical specialties has already been demonstrated, in particular in intensive care in the case of haemodynamic failure, or in intra and extra hospital emergency medicine for the initial assessment of chest pain or dyspnoea. Echocardiography also plays a major role in screening for heart disease, particularly valvular heart disease. In countries with very limited access to echocardiography, there is a major under-diagnosis of heart valve disease, including rheumatic fever, which affects 30 million people and causes 305,000 deaths worldwide. As this is a global public health problem, recommendations were drafted in 2012 to organise and facilitate echocardiographic screening of populations at risk. The expansion of the use of echocardiography has been catalysed by the miniaturisation of ultrasound systems and the reduction in their price. Recently, probes directly connected to a tablet or phone have been developed at a limited cost. It is therefore possible to consider these ultrasound scanners as the new stethoscope that could be used by any health professional. In order to be effective, the last limit to this democratisation is the training, and in particular that of non-specialists (i.e. non-cardiologists). Echocardiography remains an examination that requires anatomical knowledge and practice. Performing an echocardiogram involves visualising the heart from different points on the chest. The three main points are in the left paraspinal area, at the apex of the heart and under the sternum. From these areas, the operator must obtain several reference views which are strictly defined in order to be able to correctly observe the different cardiac structures and make comparable measurements from one examination and clinician to another. It is therefore necessary first of all to learn how to handle the probe and to be able to obtain the reference views. The morphology of the patient, the shape of the thorax, the exact position of the heart, the movements of the heart according to the position of the patient and his breathing are all elements to be taken into account and make each examination different from the previous one.