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Heart Diseases clinical trials

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NCT ID: NCT06154473 Recruiting - Cardiac Disease Clinical Trials

Assessment of Patients Undergoing Cardiac Surgery and Admitted to the Intensive Care Unit

BraSIS-2
Start date: September 1, 2023
Phase:
Study type: Observational

The objective of this study is to investigate the incidence of death and early postoperative complications, identify potential risk factors, and examine the demographic characteristics of patients and epidemiology of cardiovascular procedures. Our hypothesis is that gaining a more comprehensive understanding of the characteristics of patients who undergo cardiac surgery has the potential to improve outcomes for this patient profile. Thus, information was sought regarding the patient characteristics, surgeries performed, anesthesia administered, incidence of intraoperative and postoperative complications, and risk factors associated with complication and mortality in the ICU. The main questions it aims to answer are: - Incidence of mortality or severe postoperative complications that occur within the first 3 postoperative days or until discharge from the ICU. - Risk factors associated with severe complications in patients who undergo cardiac surgery. - Characteristics of patients, anesthesia and surgical procedures performed - Incidence of severe intraoperative complications and moderate postoperative complications - Evaluate the influence of accumulated fluid balance on outcomes, mortality, and length of ICU stay. - Evaluate mortality in the ICU. - Describe the risk factors associated with mortality.

NCT ID: NCT06154265 Enrolling by invitation - Clinical trials for Coronary Artery Disease

Intraoperative Echocardiography in Low-Risk CABG Surgery

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

This goal of this study is to better understand when and where intraoperative transesophageal echocardiography (TEE) should (or should not) be used during coronary artery bypass graft (CABG) surgeries.

NCT ID: NCT06154018 Completed - Cardiac Surgery Clinical Trials

Heparin Reversal With Two Different Protamine Ratios After Cardiopulmonary By-pass.

Start date: March 18, 2023
Phase: N/A
Study type: Interventional

Protamine is routinely used as a heparin reversal agent in cardiac surgery. However, its use may be associated with adverse events, while protamine excess may have additional anti-coagulant affect. Although guidelines advise towards a diminished reversal ratio, clinical practice remain heterogenic. The purpose of this study is to compare two different reversal ratios (0.6:1 και 0.8:1) of total heparin regarding the Activated Clotting Time (ACT), viscoelastic assays (Clot-Pro) and clinical hemorrhage. A baseline ACT value and Clot Pro tests will be obtained prior to the operation start. After the initial reversal, ACT, Clot Pro tests will be conducted again. Coagulation factors are administrated according to Clot Pro results, and in case of ongoing clinical hemorrhage and any indication of heparin excess in the measured values, another 25mg of protamine is administrated, while tests are repeated.

NCT ID: NCT06153459 Recruiting - Clinical trials for Congenital Heart Disease (CHD)

Cord Clamping Among Neonates With Congenital Heart Disease

CORD-CHD
Start date: December 19, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare 2 different timepoints for clamping the umbilical cord at birth for term-born infants with a prenatal diagnosis of congenital heart disease (CHD). The main questions it aims to answer are: - Does Delayed Cord Clamping at 120 seconds (DCC-120) or Delayed Cord Clamping at 30 seconds (DCC-30) after birth lead to better health outcomes? - Does DCC-120 seconds or DCC-30 seconds after birth lead to better neuromotor outcomes at 22-26 months of infant age (postnatal)? Participants will be asked to do the following: - Participate in either DCC-120 or DCC-30 at birth (randomized assignment). - Complete General Movements Assessment (GMA) at 3-4 months of infant age (postnatal), complete questionnaires / surveys at this time. - Complete questionnaires / surveys at 9-12 months of infant age (postnatal). - Complete Hammersmith Infant Neurological Examination (HINE), Developmental Assessment of Young Children 2 Edition (DAYC-2), and questionnaires / surveys at 22-26 months of infant age (postnatal). - Permit data collection from electronic medical records for both the mother and infant study participants. Investigators will compare DCC-120 vs. DCC-30 to see which approach is more beneficial to both the mother and baby with CHD.

NCT ID: NCT06150989 Recruiting - Clinical trials for Cardiovascular Diseases

Black Women's Life Experience On Cardiovascular Health Via Ongoing Monitoring

BLOOM
Start date: March 4, 2024
Phase:
Study type: Observational

This pilot study uses a state-of-the-science combination of remote behavioral monitoring, real-time experience sampling, in-lab physiological assessments, and extraction of neighborhood-level characteristics to (1) Examine the impact of daily experience (i.e., racial discrimination, affective states, stress) on health behaviors (i.e., physical activity, sedentary behavior, sleep) at the intrapersonal level among Black women; (2) Test the association between daily behaviors and impairments in biomarkers associated with vascular function/health (i.e., augmented systemic inflammation and oxidative stress, impaired peripheral/cerebral vascular function, increased large artery stiffness), as well as the impact of daily experience on the relationship between behaviors and vascular function; and (3) Explore the influence of neighborhood-level characteristics (i.e., social environment factors: i.e., neighborhood income and poverty, racial composition; and built environment context, such as park density and walkability) on daily experience and health behaviors.

NCT ID: NCT06150274 Completed - Clinical trials for Rheumatic Heart Disease

Comparison of Wire Assisted Percutaneous Balloon Mitral Valvulotomy With Standard Inoue Balloon Valvulotomy

CROSSVal
Start date: May 24, 2024
Phase: N/A
Study type: Interventional

The goal of this randomised study is comparison of wire assisted balloon mitral valvulotomy to standard Inoue balloon technique on patients with rheumatic mitral stenosis. The main question it aims to answer is whether procedure time is reduced using the wire assisted method. Participants will be randomized to one of the two methods.

NCT ID: NCT06149806 Recruiting - Clinical trials for Complex Congenital Heart Disease

National Registry of Adult Heart Failure Patients With Complex Congenital Heart Disease: Systemic Right Ventricle and Single Ventricle Treated With Sacubitril/Valsartan

ISACC
Start date: July 1, 2021
Phase:
Study type: Observational

Heart failure in adults with congenital heart disease is a major cause of morbidity and mortality. Patients with systemic right ventricle (SRV) and single ventricle (SV) are particularly at risk1, 2, 3. There are no specific recommendations for the management of heart failure in adults with congenital heart disease, whose management is based on "general cardiology" recommendations4,5. Sacubitril/Valsartan is validated as a treatment for heart failure in adults with acquired pathological left ventricular dysfunction (left ventricular ejection fraction (LVEF) < 40%, New York Heart Association (NYHA) functional class II and III despite optimal heart failure therapy)7. Although this molecule is used in current practice in patients with congenital heart disease, published data are limited 6-10. The aim of our work is to describe the efficacy and tolerability of Sacubitril/Valsartan in the treatment of chronic heart failure on VDS and VU through an observational, prospective, multicenter registry. The latest heart failure treatment guidelines, updated in 202111, recommend the addition of type 2 sodium-glucose co-transport inhibitors in heart failure patients with impaired ejection fraction (class IA recommendation). Two molecules are used in current practice: dapagliflozin and empagliflozin, at a single dosage of 10 mg/day. We will also be collecting data on the efficacy and safety of iSGLT2. It should be noted that, for practical reasons, there may be a delay between the end of the 1st study period (ISACC1) of one year and the start of the 2nd study period (ISACC2). Follow-up examinations carried out during the study period will not differ from those currently recommended in current practice5.

NCT ID: NCT06149143 Recruiting - Cardiac Disease Clinical Trials

Cardiac Performance System Data Collection Study - Minnesota

Start date: October 3, 2023
Phase:
Study type: Observational

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

NCT ID: NCT06145035 Recruiting - Clinical trials for Ischemic Heart Disease

Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy

CATO
Start date: March 4, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase IIA, randomized, double blind, placebo controlled, multicenter study designed to assess the safety, feasibility, and efficacy of umbilical cord derived mesenchymal stromal cells (UC MSCs), administered intravenously (IV) as a single dose or repeated doses, in patients with ischemic cardiomyopathy (ICM).

NCT ID: NCT06139094 Completed - Clinical trials for Ischemic Heart Disease

MCG for Suspected INOCA Confirmed by Thermodilution-Derived CFR

MICRO(T)
Start date: December 20, 2023
Phase:
Study type: Observational [Patient Registry]

This study will be an observational registry to investigate the ability of magnetocardiography (MCG) in determining the presence of myocardial ischemia with the absence of obstructive coronary artery disease, by using an invasive reference standard coronary flow reserve (CFR) measured using thermodilution for diagnosis. The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with cloud processing software. A CardioFlux scan appointment shall last approximately 15 minutes in duration and include a patient questionnaire following the scan.