
COPES Phase I Randomized Controlled Trial of Treatment For Distress in Heart Disease Patients
Heart DiseasesDepressionThe specific aim of the "Coronary Patients Evaluation Study" (COPES) Project 2 is, within a Phase-I RCT, to examine patient satisfaction, treatment safety, and symptom reduction associated with treatment for symptoms of distress and/or depressed mood among post acute coronary syndrome (ACS) patients, as compared to usual cardiology care. For the purposes of this study, "symptoms of distress and/or depressed mood" is defined by a score on the Beck Depression Inventory (BDI) >10. The specific treatment approach utilized follows the, "Improving Mood-Promoting Access to Collaborative Treatment" (IMPACT) Clinical Trial, and involves up to 6-months of a patient preference, stepped-care protocol. Within this protocol, patients choose between brief, problem focused psychotherapy and anti-depressant medication. Treatment progress is reviewed at 2-month intervals, providing opportunities to 'step-up' treatment if patients are not demonstrating sufficient symptom reduction.

Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart Network
Cardiovascular DiseasesHeart Diseases2 moreThe primary endpoint is coronary artery diameter, normalized for body surface area, 5 weeks after randomization. Secondary endpoints include duration of fever, CRP levels, and adverse events.

A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With...
Coronary DiseaseCoronary Arteriosclerosis1 moreThe Torcetrapib project was terminated on December 2, 2006 due to safety findings. To look at ultrasound images taken in the blood vessels of the heart and to look at various lipids in the blood of people with known coronary heart disease

A Cluster Randomized Trial to Assess the Impact of Opinion Leader Endorsed Evidence Summaries on...
Coronary DiseaseIschemic Heart Disease1 moreBACKGROUND: Although much has been written about the influence of local opinion leaders on clinical practice, there have been few controlled studies of their effect, and almost none have attempted to change prescribing in the community for chronic conditions such as congestive heart failure (CHF) or ischemic heart disease (IHD). These two conditions are common and there is very good evidence about how to best prevent morbidity and mortality - and very good evidence that quality of care is, in general, suboptimal. Practice audits have demonstrated that about half of eligible CHF patients are prescribed ACE inhibitors (and fewer still reaching appropriate target doses) and less than one-third of patients with established IHD are prescribed statins (with many fewer reaching recommended cholesterol targets). It is apparent that interventions to improve quality of prescribing are urgently needed. HYPOTHESIS: An intervention that consists of patient-specific one-page evidence summaries, generated and then endorsed by local opinion leaders, will be able to change prescribing practices of community-based primary care physicians. DESIGN: A single centre randomized controlled trial comparing an opinion leader intervention to usual care. Based on random allocation of all physicians in one large Canadian health region, patients with CHF or IHD (not receiving ACE inhibitors or statins, respectively) recruited from community pharmacies will be allocated to intervention or usual care. The primary outcome is improvement in prescription of proven efficacious therapies for CHF (ACE inhibitors) or IHD (statins) within 6 months of the intervention.

Sitosterolemia Extension Study (0653-004)(COMPLETED)
Lipid MetabolismInborn Errors1 moreThis is an extension study for patients having unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study will evaluate the long term safety and the ability to lower cholesterol levels with an investigational drug.

An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia...
Lipid MetabolismInborn Errors1 moreThis is a 6-month study with patients who have the rare disease, sitosterolemia which may result in heart-related diseases. These patients have unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study investigates whether absorption of these non-cholesterols can be reduced in these patients.

Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic...
Heart DiseasesHeart TransplantationThe purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.

Angioplasty and Heart Stents to Treat Individuals With an Occluded Artery Following a Heart Attack...
Cardiovascular DiseasesCoronary Disease2 moreThe purpose of this study is to evaluate arterial patency and left ventricular ejection fraction by examining angiographic data one year following a heart attack and treatment with late revascularization.

Qigong Therapy For Heart Device Patients
Depressive DisorderCardiac DiseasesThe goal of this study is to improve the overall physical health and quality of life of patients attached to mechanical heart devices while awaiting heart transplantation. Qigong, an ancient Chinese exercise that involves active participation of the individual in the form of meditation, breathing exercises and simple physical movements, is used in combination with a structured exercise program. We are testing the hypotheses that Qigong, in combination with a structured exercise program that combines aerobic and resistance training will improve the cardiovascular health and improve the quality of life of patients on mechanical heart devices. To test these hypotheses, we are measuring cardiovascular function and quality of life parameters in patients attached to mechanical heart devices who have participated in the exercise program and have practiced Qigong, and comparing these measures to patients who participated in the exercise program, but did not practice Qigong. Information gained from this research will serve as a basis from which the application of exercise training and Qigong can be applied to the treatment of other chronic diseases in which the physical conditioning and/or quality of life of individuals is compromised.

Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn
Heart DiseasesHawthorn (Crataegus oxyacantha) is a natural product that is popular in European and American herbal medicine practice. Some of its cardiac uses include the treatment of high and low blood pressure, rapid heart beat, chest pain, and blocked arteries. In many cases, it is used as an adjuvant agent with other cardiac drugs such as digoxin, amiodarone, and warfarin. To date, little information is known about the effect of hawthorn when taken with other drugs and if toxicities occur when hawthorn is used with other drugs. The purpose of this study is to examine the interaction between digoxin and hawthorn in eight healthy subjects. Subjects will be recruited by advertisement. The design of the study will include a 10-day and a three-week treatment phase of digoxin 0.125 mg - 0.25 mg/day and hawthorn (Crataegus special extract WS1442, Schwabe Co.) 450 mg twice daily or placebo, with a randomized crossover. There will be a three-week washout period in between treatment phases. On day 10 (phase I) and day 21 (phase II), subjects will have 12 blood samples drawn for pharmacokinetic analysis. The plasma samples will be measured for digoxin concentration. Additionally, the subjects will be assessed for any clinical toxicities or adverse events. The significance of this study is to provide the clinician with information regarding the safe use of digoxin in combination with the herbal supplement, hawthorn.