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Heart Diseases clinical trials

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NCT ID: NCT01135485 Completed - Clinical trials for Congenital Heart Disease

Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Left Heart Syndrome

Start date: March 2010
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether children and adolescents 8-18 years of age with HLHS and related lesions who have undergone stage I palliation during infancy using an allograft patch demonstrate continued evidence of HLA antibody formation.

NCT ID: NCT01131715 Completed - Clinical trials for Patient Satisfaction

Pharmacist Follow-up, a Qualitative Study of Patient Experience

Start date: February 2010
Phase:
Study type: Observational

A pharmacist follow-up procedure is under development. Patients with coronary heart disease (CHD) is being followed up by a pharmacist for one year with three meetings; at discharge from hospital, after three months and after one year. The evaluation is basically based on quantitative measures as achievement of therapeutic goals, number of drug related problems detected, hospitalisations etc. However, the patients' own experience with the follow-up procedure cannot be evaluated using these measures. Thus, a qualitative approach is needed. In this study, a total of four patients participating in the follow-up will be included and interviewed. A semistructured interview guide will be used. Interviews will be taped, transcribed and analyzed with the intention to explore how patients experience the follow-up from the pharmacist. A thoruough content analysis will be performed. Patients included must have met the pharmacist at least twice. The pharmacist in charge of the follow-up will recruit patients and hand out study information. Patients will reply to the principal investigator of the study and thus kept anonymous for the pharmacist in charge of the follow-up. No pressure will be put on the patients to join, but it will be emphasized that it will help evaluating the procedure.

NCT ID: NCT01126372 Completed - Clinical trials for Congenital Heart Disease

Prediction of Feeding Problems in Prostaglandin-dependent Prematurely Born Infants With Congenital Heart Disease

Start date: May 2010
Phase: N/A
Study type: Observational

Prematurely born infants with ductal-dependent congenital heart disease (CHD) are at increased risk to develop necrotizing enterocolitis (NEC). Abnormal left to right blood flow through a patent ductus arteriosus can cause intestinal ischemia and compromise the gastrointestinal tract as a barrier to infection. In some infants, bacterial translocation leads to NEC which may result in death, intestinal perforation, cholestasis and, at the very least, feeding problems. Predicting which infants with CHD will develop NEC will potentially decrease the severity of disease if interventions were started earlier. Near-infrared spectroscopy (NIRS) allows determination of regional oxygen saturation levels in tissues such as brain, kidney, and as recently reported, intestine. This study will test whether or not decreasing intestinal oxygen saturations can predict the development of NEC in this at risk population before the symptoms become severe. NIRS probes will be placed on the forehead, flank and abdomen of eligible infants and regional oxygen saturations will be recorded prospectively and continuously with the clinical care team blinded to the data. The development of NEC and significant feeding problems will then be correlated with the regional oxygen saturations to determine whether decreased intestinal oxygen saturations predicted early signs and symptoms of NEC. We anticipate generating pilot data in 30 infants who meet inclusion criteria. Support of this research will be provided partially by Somanetics, the manufacturer of the INVOS regional oxygen saturation monitors. They will, however, have no control over the data generated by this study.

NCT ID: NCT01126073 Completed - Clinical trials for Coronary Heart Disease

Niacin/Laropiprant and Endothelial Function

Start date: September 2010
Phase: Phase 4
Study type: Interventional

Primary objective: To evaluate the impact of 12 weeks' administration of extended release niacin/laropiprant (ERN/LRPT) compared to placebo added to statin therapy on endothelial dependant dilatation of the arterial wall assessed by brachial vasoreactivity in stable coronary heart disease (CHD) patients. Secondary objective: To evaluate the impact of 12 weeks' administration of extended release niacin/laropiprant (ERN/LRPT) compared to placebo added to statin therapy on serum lipids and the parameters of inflammation in stable coronary heart disease (CHD) patients. CHD-coronary heart disease ER-extended release

NCT ID: NCT01117506 Completed - Clinical trials for Coronary Artery Disease

Coronary Obstruction Detection by Molecular Personalized Gene Expression (Corus CAD or ASGES)

COMPASS
Start date: April 2010
Phase:
Study type: Observational

To validate the use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood assay in subjects who are referred for the work-up of coronary artery disease. The study will evaluate the clinical utility of a gene expression test Corus CAD (Age, Sex, Gene Expression Score - ASGES) in subjects referred for myocardial perfusion imaging (MPI) work-up for suspected obstructive atherosclerotic coronary artery disease (CAD). The Corus CAD (ASGES) is a gene expression test that quantify the expression of multiple genes from circulating peripheral blood cells to detect the presence of clinically significant obstructive CAD in patients with chest pain.

NCT ID: NCT01115608 Completed - Clinical trials for Coronary Heart Disease

Pharmaceutical Follow-up of Coronary Heart Disease (CHD) Patients

Start date: February 1, 2009
Phase: N/A
Study type: Interventional

Objectives To explore the impact of a clinical pharmacist-led 12 month lasting follow-up program for patients with established coronary heart disease (CHD) discharged from the North Norway University Hospital. Methods A total of 102 patients aged 18-82 years were enrolled in a non-blinded, randomized controlled trial. The intervention comprised medication reconciliation, medication review and patient education during three meetings; at discharge, after three months and after twelve months. The control group received standard care from their general practitioner. Primary outcomes were adherence to clinical guideline recommendations concerning prescription, therapy goal achievement and lifestyle education defined in the medication assessment tool for secondary prevention of CHD (MAT-CHDSP). Secondary outcomes included changes in the biomedical risk factors cholesterol, blood pressure and blood glucose. Key findings Ninety-four patients completed the trial, 48 intervention group patients and 46 controls. Appropriate prescribing was high, but therapy goal achievement was low in both study groups throughout the study. Overall adherence to MAT-CHDSP criteria increased in both groups and was significantly higher in the intervention group at study end compared to the control group, 78.1% vs. 61.4%, P < 0.001. The difference was mainly due to an increased documentation of lifestyle advices in intervention group patients. No significant improvements in biomedical risk factors were observed in favor of the intervention group, possible due to an underpowered study. Conclusion The clinical pharmacist-led follow-up program significantly increased documented lifestyle advices defined in the MAT-CHDSP for the intervention group, but did not lead to significant improvements in biomedical risk factor measures in favor of the intervention group. Even if prescribing was high, therapy goal achievement was low in both study groups. Changes to the follow-up program are warranted, in addition to a larger, adequately powered study, before implementation in standard patient care can be recommended.

NCT ID: NCT01098994 Completed - Type 1 Diabetes Clinical Trials

Haptoglobin Phenotype, Vitamin E and High-density Lipoprotein (HDL) Function in Type 1 Diabetes

HAP-E
Start date: February 2010
Phase: N/A
Study type: Interventional

The purpose of the study is to determine whether the function of the good cholesterol (HDL cholesterol) as well as its subfractions (via NMR spectroscopy) is altered among people with type 1 diabetes and a variation in the Haptoglobin gene and to evaluate whether vitamin E supplements may improve this function.

NCT ID: NCT01098591 Completed - Clinical trials for Ischemic Heart Disease

Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE

ACCRUE
Start date: November 2007
Phase:
Study type: Observational

Numerous human cardiac stem cell studies have been published, including relatively small number of patients. Meta-analysis of randomized trials have reported safety and a 3-6% increase in global left ventricular performance after intracoronary stem cell therapy in patients with acute myocardial infarction. Since most of the studies used different type of stem cells, delivery modes, and patient population, the results are heterogenous, therefore the comparison of the results is biased regarding generalizable conclusions about the effect of treatment. The present comparative meta-analysis is based on individual patient data, and gathers and pools the raw data, and analyzes the clinical outcome, safety and efficacy of the cardiac stem cell therapy.

NCT ID: NCT01096693 Completed - Heart Disease Clinical Trials

Effects of Urocortins on Forearm Arterial Blood Flow in Healthy Volunteers (Protocol 2)

Start date: August 2010
Phase: N/A
Study type: Interventional

Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem with a poor prognosis and the search for novel treatments remains an important area of research. Urocortins are proteins that appear to increase blood flow and heart pumping activity. There has been particular interest in the role of Urocortins 2 & 3 (subtypes of Urocortins) in heart failure. In this study, we will examine the effects and mechanisms of Urocortins 2 & 3 and the Corticotrophin Releasing Hormone Receptor Type 2 (CRH-R2) receptor (through which urocortins act) on forearm blood flow and release of natural blood clot dissolving factors in the forearm circulation of healthy volunteers. In this study, we will look at the role of the lining of the blood vessel (endothelium) in response to urocortin types 2 and 3. We hypothesise that urocortins 2 & 3 act via the endothelium to cause dilatation of the blood vessels and release of tissue-plasminogen activating factor (blood clot dissolving factor). We also hypothesise that urocortins have a role in maintaining the normal baseline level of blood flow in forearm arteries. In addition to the above, we will also look at the effect of temporarily blocking the effect of urocortins, using a specially designed blocker drug (Astressin 2B). Utilising the well-established technique of 'forearm venous occlusion plethysmography', we will be able to focus on the local effects of urocortins on arterial blood flow in forearm vessels, without affecting this system in the body as a whole.

NCT ID: NCT01081210 Completed - Dyspnea Clinical Trials

Screening of Patients Admitted to a Local Hospital With Pocket-sized Ultrasound

Start date: March 2010
Phase:
Study type: Observational

Ultrasound (US) is widely used as a diagnostic tool in a hospital setting. In a medical department, diagnosis like heart failure or most kinds of heart diseases, hypervolemia, hypovolemia, pleural effusion, pericardial effusion, ascites, diseases in the gall bladder/bile tract, urine tract and venous thrombosis are common. US is the key diagnostic tool in these diagnosis, and on early diagnosis is crucial both on behalf of the patients well-being, and for hospital logistic reasons. 1. The aim is to study the clinical use of pocket sized US as a screening diagnostic tool in an department of internal medicine. Method: All patients admitted (in certain preset periods) to Department of medicine will be screened with pocket sized US by expert user. Changes in diagnoses, as well as medications as a result of US screening will be the endpoints. US findings will be validated against standard echocardiography, or standard US/CT/MRI performed at the Radiological department. 2. The aim is to study the clinical use of pocket sized US as a screening diagnostic tool in a department of cardiology. Method: All patients admitted (in certain preset periods) to Department of cardiology will be screened with pocket sized US for heart disease, pericardial and pleural effusion. Examinations by expert users. Specific findings could be myocardial dysfunction as heart failure, cardiomyopathies, regional dysfunction due to ischemia, valvular dysfunction, atrial enlargement, and pleural/pericardial effusion. Changes in diagnoses, as well as medications as a result of US screening will be the endpoints. US findings will be validated against standard echocardiography in all. 3. As in 1), but examination by non-expert users compared to expert users.