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Heart Diseases clinical trials

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NCT ID: NCT03583775 Completed - Clinical trials for Congenital Heart Disease

3D Cine Cardiovascular Magnetic Resonance

Start date: November 1, 2019
Phase:
Study type: Observational

Conventional CMR is based on breath-hold 2D cine image acquisitions which are sequentially acquired in different imaging planes. The necessity of precisely planning and then acquiring multiple 2D imaging planes during breath-hold is relatively inefficient and leads to CMR exam times of ≤60 minutes. However, some patients are too ill or young to hold their breath. Furthermore, 2D images sometimes fail to provide a complete picture of complex 3D anatomy of patients with complex morphology. To address these limitations, we have recently developed a 3D cine (3 spatial dimensions plus time) CMR technique. Rather than acquiring 2D cine images in multiple orientations during breath-hold, this approach allows one to acquire a free-breathing 3D block of data for each phase of cardiac cycle that can be reformatted offline into the desired views without adding to the exam time. This added efficiency should lead to a reduction in CMR exam time, increasing patient comfort, and making CMR exam easy and available for all. In addition, the 3D nature of the data may yield more complete information about the anatomy and physiology. In this proposal, we will examine the agreement between the 2D cine and 3D cine CMR techniques with regard to left and right ventricular volumes and systemic and pulmonary blood flow circulation. The internal consistency of the measurements between the 2 techniques will be also investigated. This study will focus on children because they may benefit the most from the short, improved efficiency, and free-breathing CMR exams.

NCT ID: NCT03583320 Active, not recruiting - Clinical trials for Coronary Artery Disease

Trial of Cardiac CT in Acute Chest Patients With Intermediate Level Initial High-sensitivity Cardiac Troponin

PROTECCT
Start date: January 12, 2018
Phase: N/A
Study type: Interventional

Patients who present to the emergency department (ED) with acute chest pain (ACP) possibly due to Coronary artery disease (CAD), with a normal heart tracing (ECG), need to have further troponin blood tests to confirm or exclude a heart attack. After initial troponin testing, a significant 50-85% of patients are said to be in an "observational zone" as one cannot confirm or exclude a diagnosis of a heart attack. Even after repeat blood testing, 22-33% remain in this "observational zone". These patients can be challenging to manage as they are not safe to be discharged home, but they also cannot be treated as a heart attack. This contributes to ED overcrowding and uncertainty in treatment plans.

NCT ID: NCT03579641 Completed - Heart Failure Clinical Trials

Precision Event Monitoring for Patients With Heart Failure Using HeartLogic

PREEMPT-HF
Start date: June 1, 2018
Phase:
Study type: Observational

The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator. There are no primary safety and/or efficacy endpoints for this study. Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet clinical need to slow the progression of Heart Failure and prevent hospitalizations. HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators, combines novel sensor parameters such as heart sounds and respiration with other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index for the early detection of worsening Heart Failure. However, there is limited data on the association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or for phenotyping the broad spectrum of Heart Failure patients.

NCT ID: NCT03577821 Not yet recruiting - Clinical trials for Ischemic Heart Disease

Early Outcome of Total Arterial Revasclarization in IHD

Start date: July 1, 2018
Phase:
Study type: Observational

Complete arterial coronary artery bypass grafting (CABG) is a surgical option to improve long-term results in the treatment of coronary artery disease (CAD). The goal of coronary artery bypass operations is complete revascularization and there is an increasing interest toward complete arterial revascularization to achieve this goal because of high late failure of saphenous vein graft

NCT ID: NCT03576534 Terminated - Clinical trials for Congenital Heart Disease

Pre Bypass Ultrafiltration (PBUF) in Children Requiring Cardiopulmonary Bypass

PBUF
Start date: October 3, 2019
Phase: N/A
Study type: Interventional

Newborn babies and children with congenital heart defects who need heart surgery need to be placed on the heart-lung machine for heart surgery. In order to use the heart-lung machine, the investigators have to use blood and other fluids to fill the tubing. During the operation, ultrafiltration is carried out as standard of care to remove extra fluid. Modified ultrafiltration is also performed after surgery. In this study, the investigators are looking to use the filter additionally before surgery. Using the pre bypass filtration before the subject is placed on the heart-lung machine will allow the investigators to better normalize electrolytes in the blood/fluid mixture used in the heart lung machine. This technique is called pre-bypass ultrafiltration, or PBUF (pronounced "P" Buff). The investigators are conducting a study to see if using PBUF to better normalize electrolytes in the blood will make a difference. The investigators have been adding fluids to prime the heart-lung machine in two different ways. The investigators believe both methods are safe and acceptable but hypothesize that there may be subtle differences in electrolytes and fluid status when one technique is used as opposed to the other. The investigators believe that neither technique introduces risk since both are currently used in practice. The standard method adds blood to the heart-lung machine. The alternate method adds blood to the heart-lung machine and then additional fluid is added and removed to more normalize the electrolytes. The investigators plan to randomized subjects undergoing heart surgery to receive the standard priming method versus PBUF to determine if there is any difference in outcomes. Laboratory and clinical data collected as part of clinical care will be used to determine difference sin outcomes. There will be no additional blood taken for this study. There are no known risks to PBUF. The benefits include helping investigators determine if PBUF does or does not make a difference to how subjects recover after surgery. The investigators believe that providing more normal blood values will either improve the subjects' outcome or have no benefit. The investigators do not anticipate increased risks. Given COVID -19 restrictions, the study is on hold.

NCT ID: NCT03575910 Active, not recruiting - Heart Failure Clinical Trials

HEARTBiT: Multi-Marker Blood Test for Acute Cardiac Transplant Rejection

HEARTBiT
Start date: August 9, 2018
Phase:
Study type: Observational

Heart transplantation is a life saving therapy for people with end stage heart failure. Acute rejection, a process where the immune system recognizes the transplanted heart as foreign and mounts a response against it, remains a clinical problem despite improvements in immunosuppressive drugs. Acute rejection occurs in 20-30% of patients within the first 3 months post-transplant, and is currently detected by highly invasive heart tissue biopsies that happen 12-15 times in the first year post-transplant. Replacing the biopsy with a simple blood test is of utmost value to patients and will reduce healthcare costs. The goal of our project is to develop a new blood test to monitor heart transplant rejection. Advances in biotechnology have enabled simultaneous measurement of many molecules (e.g., proteins, nucleic acids) in blood, driving the development of new diagnostics. Our team is a leader in using computational tools to combine information from numerous biological molecules and clinical data to generate "biomarker panels" that are more powerful than existing diagnostic tests. Our sophisticated analytic methods has recently derived HEARTBiT, a promising test of acute rejection comprising 9 RNA biomarkers, from the measurement of 30,000 blood molecules in 150 Canadian heart transplant patients. Our objective is to study a custom-built HEARTBiT test in a setting and on a technology that enable clinical adoption. We will evaluate the new test on 400 new patients from 5 North American transplant centres. We will also track patients' HEARTBiT scores over time to help predict future rejection, and explore use of proteins and micoRNAs to improve HEARTBiT. Our work will provide the basis for a future clinical trial. The significance of this work rests in that it will provide a tool to identify acute cardiac rejection in a fast, accurate, cost-effective and minimally invasive manner, allowing for facile long-term monitoring and therapy tailoring for heart transplant patients.

NCT ID: NCT03575572 Terminated - Heart Diseases Clinical Trials

Colchicine in Postoperative Fontan Patients

CPFP
Start date: August 29, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators found that there is inflammation in the chest drainage in patients after the Fontan operation. The investigators want to test the theory that Colchicine, an anti- inflammatory medication, can decrease the inflammation in the chest tube drainage after the Fontan operation, and can decrease the amount of time that patients having this surgery will have drainage.

NCT ID: NCT03571906 Not yet recruiting - Clinical trials for Valvular Heart Disease

Pre-habilitation of Patients Scheduled for Cardiac Valve Surgery

Start date: July 2018
Phase: N/A
Study type: Interventional

Cardiac rehabilitation (CR) is an integral part of cardiovascular disease management incorporating aspects of scientifically constructed appropriate physical exercise. CR has been repeatedly shown to significantly improve functional capacity, depression and wellbeing, even following short term interventions. Functional capacity is closely related to frailty, a key prognostic factor in subjects undergoing cardiac surgery. We intend to enroll 50 stable subjects with valvular heart disease scheduled for surgical intervention. Our hypothesis is that the Prehab group will improve their functional capacity to a greater degree than the usual care group, possibly associated with better clinical outcomes.

NCT ID: NCT03571672 Completed - Cardiac Disease Clinical Trials

DEF-314 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY

BENEFIT1
Start date: October 24, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase 3, prospective, open-label, multicenter study to evaluate Left Ventricular Ejection Fraction (LVEF) measurement accuracy and reproducibility of DEFINITY® contrast-enhanced and unenhanced echocardiography as compared with non-contrast cardiac magnetic resonance imaging (CMR) used as the truth standard.

NCT ID: NCT03569085 Completed - Heart Diseases Clinical Trials

Inhaled Anesthetics and Myocardial Strain

Start date: June 27, 2018
Phase: Phase 1
Study type: Interventional

Speckle tracking imaging measuring software will be used for offline analysis of transesophageal echocardiogram (TEE) -acquired images of the left ventricle(LV) in four chambers(4C), two chambers (2C) and long axis (LAX) views to calculate global longitudinal strain (GLS) of LV for comparisons between sevoflurane and isoflurane at the same minimum alveolar concentration ( MAC) levels.