Biomarkers in Pediatric Congenital Heart Disease and PAH
Congenital Heart DiseasePulmonary Arterial HypertensionNowadays, biomarkers are broadly used in clinical practice. Blood-derived biomarkers fulfil an important role in the field of cardiology. However, most biomarkers have been investigated for adult left ventricular disease. In congenital heart diseases (CHD) and pulmonary arterial hypertension (PAH), which involves children and mostly the right ventricle, less is known about the clinical and predictive value of blood-derived biomarkers. Since the group of survivors of CHD and PAH is growing because of the improved techniques nowadays, development of better tools to maintain the quality of life for the longer term in these patients is urgently needed. Blood-derived biomarkers are minimally invasive biomarkers, are quantitative and have shown to be able to reveal pathological processes in an early stage. Hence, blood-derived biomarkers may be a good addition to current diagnostic means in CHD and PAH. Objective: The primary objective of this study is to investigate cross-sectionally the association between various emerging blood-derived biomarkers and right ventricular (RV) function:defined as tricuspid annular plane systolic excursion (TAPSE) measured with echocardiography, in children with (a history of ) an abnormally loaded, volume and/or pressure loaded, right ventricle associated with CHD and/or PAH.
Pre Bypass Ultrafiltration (PBUF) in Children Requiring Cardiopulmonary Bypass
Congenital Heart DiseaseNewborn 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.
Anti-chlamydophila Antibiotic Combination Therapy in the Treatment of Patients With Coronary Heart...
Coronary Heart DiseaseChlamydophila Pneumoniae InfectionsThe purpose of the study is to see whether the antibiotic combination of 100mg doxycycline, 500mg azithromycin and 300mg rifabutin is a safe and effective treatment for coronary artery disease which has not responded to 'standard treatment'. Coronary artery disease is the process of plaque build up within the walls of the arteries responsible for supplying the heart with oxygen and nutrients. plaque is usually made up of fatty deposits, minerals and various amounts of tissue and white cells which eventually narrows the artery, reducing blood flow to the heart. The resulting damage and build up of fat leads to inflammation of the arterial wall and eventually the arteries narrow. The researchers involved in this study consider that a pathogen called Chlamydophila pneumoniae, which can live inside cells may cause this inflammation of the arterial wall. The purpose of this study is to see if treatment with this antibiotic combination in patients with CHD is safe and effective in reducing disease severity measured at coronary angiography and improving quality of life. Approximately 60 patients will be involved in this trial. the treatment period is 90 days with a further 90 day follow up period.
A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for...
AtherosclerosisHeart Diseases3 moreEVOLVE 4.5/5.0 is a prospective, single-arm, multi-center observational (standard of care) trial intended to confirm the safety and effectiveness of the SYNERGY 4.50 mm and 5.00 mm Coronary Stent System for the treatment of patients with coronary artery disease in large vessels (≤ 28 mm in length, by visual estimate, in native coronary arteries > 4.00 mm to ≤5.00 mm in diameter, by visual estimate). This Post Approval study is a cohort associated with the SYNERGY MEGATRON Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT04807439.
Dose Optimization for Rubidium PET Imaging in Patients With Known or Suspected Ischemic Heart Disease...
Ischemic Heart DiseaseSelection of the appropriate administered activity for each patient's body habitus is very important to obtain diagnostic image quality. Current SPECT imaging guidelines suggest "…an effort to tailor the administered activity to the patient's habitus and imaging equipment should be made… [however] strong evidence supporting one particular weight-based dosing scheme does not exist." An increase in body weight leads to higher fractions of attenuated and scattered photons, resulting in lower quality PET images for a given injected activity. Weight-based tracer dosing is commonly recommended as a solution in whole-body PET imaging with F-18-FDG. In contrast, Rb-82 PET imaging has traditionally been performed using a single dose (e.g. 40 mCi) administered for all patients but this is known to result in lower count-density and image quality in larger patients. This effect can be mitigated to some degree by administration of Rb-82 activity as a proportion of body weight while maintaining accuracy for the detection of disease. The objective of this project is to determine whether Rb-82 activity administered as a squared function of patient weight (quadratic dosing) can standardize PET myocardial perfusion image quality over a wide range of body weights. Sequential patients referred for dipyridamole stress Rb-82 PET perfusion imaging at the University of Ottawa Heart Institute. Patients will be divided into 4 weight groups to determine if there are significance differences in image quality or accuracy of injected Rb-82 activity between patients. Twelve (12) patients will be recruited in each of the 4 weight groups (3 in each 10 kg interval) to uniformly sample the full range of patient weights from 30 to 190 kg. Based on the previous oncology PET literature image quality is not expected to change as a function of weight, i.e. SNR and CNR will be proportional to weight0 (no weight-dependence) with quadratic dosing of Rb-82. Two operators will perform the PET image analysis as described above.
Role of Statins In Slowing Rheumatic Heart Disease (RHD) Progression
Rheumatic Heart DiseaseValvular DiseaseThe goal of this study is to address specific implementation questions necessary and sufficient to ensure the feasibility of the larger randomized trial examining the efficacy of statin medications in slowing rheumatic heart disease (RHD) valvular pathology progression. This feasibility study is intended to confirm the number of readily recruitable subjects, assess recruitment rate, and assess the rate of valve pathology via echocardiograms. These results are necessary and sufficient to facilitate the successful design of a large full scale randomized trial to determine whether statins improve outcomes in RHD. Successful treatment of RHD would fundamentally shift the RHD management paradigm world-wide, improve the lives of millions afflicted with RHD, and subsequently, decrease health care spending on RHD management.
A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness...
Ischemic Heart DiseaseCoronary Artery DiseaseThis prospective registry is intended to evaluate the safety and efficacy of the TANSEI stent.
Use of Ritmonutra in Subjects Affected by Supraventricular Ectopic Beats Without Structural Heart...
Arrhythmiait is a prospective, randomized, double-blinded, crossover study on the use of an association of omega 3 fatty acids, astaxanthin, vitamin E and hawthorn (ritmonutra) in subject affected by symptomatic supraventricular ectopic beats without structural heart disease. The study will evaluate the reduction of the number of supraventricular ectopic beats and symptoms related.
Stem Cell Injection to Treat Heart Damage During Open Heart Surgery
Heart DiseaseIschemic Heart Disease2 moreBackground: - Bone marrow stromal stem cells (also known as mesenchymal stem cells) have been isolated and are found to make large amounts of growth factors. Because they make growth factors, these cells can help re-grow tissue and encourage repair of damaged tissue. Tests on damaged heart muscle suggest that injecting these cells directly into damaged heart muscle can improve heart function. Researchers want to give stem cells to people who are having open heart surgery to see if they can help to repair heart muscle damage. Objectives: - To test the safety and effectiveness of bone marrow stromal stem cell injections given during heart surgery to treat heart muscle damage. Eligibility: - Individuals at least 18 years of age who are scheduled to have open heart surgery for heart artery or vein blockages. Design: Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. Participants will have bone marrow taken from both hip bones about 3 weeks before the heart surgery. During the surgery, the stromal stem cells collected from the bone marrow will be given into the damaged portion of the heart muscle. The rest of the heart surgery will be performed according to standard procedures. After the surgery, participants will be monitored for complications from the stromal stem cells. Participants will have heart function tests to see if the stromal stem cell treatments were effective....
The eSVS® Mesh Post-Marketing Trial
Coronary Artery DiseaseMyocardial Ischemia6 moreThe purpose of this study is to evaluate patency rates of the eSVS Mesh Saphenous Vein Graph (SVG) and control SVG at six and twenty-four months via coronary angiography and analyses of Duplex Sonography Results and coronary angiography and major cardiovascular or cerebrovascular event (MACCE)-Rate as well as analysis of preoperative great saphenous vein (GSV) duplex sonography and intra-operative GSV harvesting findings and procedure.