Active clinical trials for "Heart Diseases"

The objective of this postmarket, retrospective, single center study is to evaluate the clinical outcomes of patients who have received PhotoFix® Decellularized Bovine Pericardium (PhotoFix) as a patch within a cardiac surgical repair or reconstruction procedure. PhotoFix is prepared from bovine pericardium, which is stabilized using a dye-mediated photo-oxidation process and sterilized using aseptic processing techniques.

In pediatric cardiac patients with shunt dependent pulmonary circulation, Qp/Qs ratio is a important parameter indicating the balance of pulmonaty and systemic circulation. This study will calculate Qp/Qs using variables measured using non-invasive monitors (cerebral oximeter and pulse oximeter). This value will be compared with Qp/Qs calculated using variables obtained from blood sample.

Use of whole blood impedance aggregometry and rotational thromboelastometry can reveal useful data about platelet function and viscoelastic properties of blood clot in patients undergoing cardiac surgery. The purpose of this study is to clarify whether it is possible to predict patients on excessive risk of perioperative bleeding using whole blood impedance aggregometry and rotational thromoelastometry. Antiplatelet therapy is the cornerstone in treatment of patients with coronary artery disease. Another research goal is to determine the degree of response to antiplatelet therapy before and after surgery and to investigate whether patients by level of response to antiplatelet therapy before surgery have a higher risk of perioperative bleeding.

The purpose is to evaluate the investigators' length of incisions based on patient weight, operative times, hospital lengths of stay, pain medicine requirements, complications and costs. These data will lead to a new minimally invasive standard of care without a reduction in outcomes.

The purpose of the investigators proposed randomized, controlled study is to examine the effect of 6 one hour treatments of Healing Touch (HT) over 3 weeks on post-cardiac event patients, while they wait to enter a Cardiac Rehab (CR) program.Patients enrolled in the Scripps Center for Integrative Medicine (SCIM) Cardiac Rehab Program typically experience a waiting period of 3 weeks, or sometimes more, before starting the program. Secondary aims of the proposed study are to evaluate the effect of HT on CR program outcome measures of METs, BMI, physical and mental well-being, and attendance in this population. New participants in the CR program who qualify and agree to participate in the study will be consented and randomly assigned to the Intervention Group who will receive Healing Touch therapy, or to the Control Group, which will not receive HT. At baseline both groups will complete the Dartmouth Quality of Life and SF-36 Health Surveys. The questionnaires will be repeated at the end of the 3 week study period and at the end of the 3 months SCIM CR program. An effect size of 15% was chosen, with an alpha level of 0.05, 80% power, 95% confidence level, and using a two-tailed test, it was determined that a sample size of 56 patients in each group would be needed for between group comparisons. To account for potential attrition the study will enroll 124 subjects, 62 in each group. Our rationale is that Healing Touch, in addition to standard medical care will reduce post-cardiac event stress and anxiety symptoms in patients waiting to enter a cardiac rehab program, as measured by the Dartmouth Quality of Life Index and the SF36 questionnaire. Further, the investigators suggest that Healing Touch treatments will improve patient's final outcomes of the 12 week CR program.

I. Study design: open/ blinded randomized, controlled study. II. Study setting and location: The study will be conducted in Abul Reesh Paediatric Hospital Faculty of Medicine /Cairo University from 2016-2018. III. Study population: This controlled open/blinded labelled randomized study is designed to include 40 children of both sexes scheduled for open-heart surgery for total correction of congenital heart diseases. IV. Eligibility Criteria: Inclusion criteria; Paediatric patients of age group ranging from 6 months to 12 years . Patients with complex congenital heart disease undergoing open heart surgery for total correction of the cardiac anomaly using cardiopulmonary bypass. Exclusion criteria; Age less than 6 months or more than12 years. Significant ventricular dysfunction (Ejection fraction < 40%). Patients with pre-existing CNS disorders e.g.: seizures. Patients with abnormal liver functions. Pre-operative creatinine level >1.2 mg /dl. Patients with history of diabetes mellitus. Patients receiving NSAID for any reason. Study Protocol; The patients will be pre-medicated by atropine 0.01mg/kg, ketamine 0.03mg/kg and midazolam 0.02mg/kg IM, 30 minutes before induction of anesthesia. Standard ASA monitors, including electrocardiogram (ECG), pulse oximetry (Spo2), and non-invasive blood pressure cuff, and INVOS somatic oximeter probes will be placed on the renal area (on the back to the right or to the left from T10 to l2) will be placed on the patients before induction of anesthesia. Anesthetic technique will be standardized for all the patients in the form of inhalational induction using sevoflurane 6% in a mixture of oxygen and air (1:1) to be followed by placement of peripheral intravenous cannula. Intubation will be facilitated by pancuronium 0.01 mg/kg IV and ventilation will be controlled using pressure mode aiming to maintain PCO2 between (30-35 mmHg). Anesthesia will be maintained by mixture of 2% sevoflurane in 1:1 oxygen: air till time of CPB. A standard CPB technique will be used in all patients. Before aortic cannulation, patients will receive IV heparin 400 U.kg-1 aiming to produce ACT value > 400 sec. A membrane oxygenator (minimax plus ;Medtronics Inc.,Anaheim,CA) will be used during CPB. Priming solution in the form of isotonic saline solution supplemented with heparin added to fresh whole blood in appropriate amounts to achieve a hematocrit 20-25% during CPB will be used. Furosemide in a dose of 1mg .kg-1.min-1 will be given to all patients. Venting of left heart will be performed with a left atrial vent inserted through a small incision at the inter-atrial septum . Anesthesia during CPB will be given by Sevoflurane administrated via a vaporizer inserted into the oxygenator gas supply with a constant gas flow 3 liter.min-1. A non-pulsatile roller pump (model10.10.00;Stocket instruments ;Munich, Germany) will be used and the pump flow will be adjusted at 2.4 to 2.6 L/min /m2 during the normothermic period targeting mean arterial blood pressure between 40 and 60 mmHg. If the MAP will fall below 40 mmHg despite full perfusion pressure, a bolus dose of 0.01-0.1 ng /Kg phenylephrine will be given. If MAP increased above 60 mmHg, a continuous infusion of nitroglycerin at a dose of 1-2 µg.kg.min-1will be given. After application of aortic cross clamp and administration of cold cardioplegia solution (Saint Thomas cardioplegic solution, 20ml/Kg to be followed by doses of 10ml/Kg every 20 min.), time will be allowed to develop a stable level of perfusion pressure and moderate hypothermia (28°C-32°C). These variables will be kept constant for at least 10 minutes after initiation of full flow CPB and initiation of the study sequence. Thereafter, patients will be randomely allocated to DEX group (Group D n=20) receiving dexmedetomidine in a dose of 3 mcg/kg over 10 minutes to be followed by an infusion of 1 mcg/kg/hr to be continued until the first 6 postoperative hours.

This is a multi-center pilot study to examine the effectiveness of a health literacy-based intervention to improve medication adherence and self-efficacy of medication use among individuals with coronary heart disease (CHD). The specific aims are to: i) develop a health literacy-based intervention to improve medication adherence for CHD individuals with low health literacy and ii) evaluate the effects of a health literacy-based intervention on improving medication adherence and self-efficacy in CHD individuals.

The implantable cardioverter defibrillator (ICD) is generally well-accepted by patients, but a subgroup experiences increased anxiety and poor quality of life. A web-based behavioral intervention may comprise a novel approach to reduce anxiety and enhance well-being in ICD patients, which may be equally effective and have advantages over more traditional forms of therapy, due to its low-threshold accessibility via the internet. The purpose of this study is to determine whether patients receiving a behavioral intervention via the internet experience less anxiety and device concerns and improved quality of life compared to patients receiving usual care.

Existing trials for the patient with coronary heart disease evaluate the interdisciplinary team dynamic where pharmacists (pharmacotherapists) provide therapeutic recommendations in the inpatient environment. To our knowledge, only other trial has evaluated the addition of a pharmacist (or nurse practitioner) in an outpatient collaborative cardiology practice and has found no benefit. However, the investigators believe that since a cardiology based pharmacist (pharmacotherapist) in the Veterans Health Administration has physical assessment skills, a shorter cycle length between appointments, and the ability to provide medication therapy management, the pharmacotherapist should be similarly successful as seen with other pharmacist based medication therapy management practices. The investigators will assess effectiveness by using the combined endpoint of blood pressure and lipid treatment. Additionally the investigators will conduct three substudies to evaluate if the pharmacist can improve all cause mortality and cardiovascular morbidity, adherence to antihypertensives, and patient satisfaction.

The overall goal of this program of research is to develop and systematically evaluate an integrated smartphone and web-based intervention (at heart [formerly called HEARTPA♀N]) to provide evidence-informed symptom triage and self-management support to reduce pain and increase health-related quality of life (HRQoL) in women with heart disease. The investigators will use the individual and family self-management theory, mobile device functionality and the pervasive information architecture of mHealth interventions, and follow the sequential phased approach recommended by the Medical Research Council (MRC) to develop at heart (progressive WebApp). Funding was received from the Canadian Institutes of Health Research to develop the architecture and conduct usability testing (Phase 2, complete) to ensure it is easy to use, efficient and satisfying to operate. In Phase 3 (current proposal), feasibility in terms of implementation (accrual rates, acceptability and level of engagement) and initial estimation of effectiveness outcomes (estimates of magnitude of effect) will be evaluated in a pilot randomized controlled trial (RCT). The Phase 3 pilot study will enable the investigators to refine the prototype, inform the methodology, and calculate the sample size for a larger multi-site RCT (Phase 4, future work).