HELP-Apheresis in Diabetic Ischemic Foot Treatment (H.A.D.I.F)
Foot UlcersArteriosclerosis Obliterans1 moreDiabetic foot (DF) is a common, severe and costly complication of diabetes. DF is underlied by neuropathy, atherosclerosis of distal arteries and infection, which result in tissue ulcers and necrosis. Alterations in microcirculatory function and in blood rheology may concur in causing tissue damage. In recent years there has been accumulating evidence that LDL apheresis (LA) does not only reduce cholesterol but also has a series of pleiotropic effects that improve the microcirculation, increasing peripheral tissue perfusion. HADIF is a randomized, multicentric, prospective clinical study aimed at assessing the effect of LDL apheresis treatment in association with traditional therapy for ulcers, in patients with an ischemic diabetic foot ulcer (class I and II Texas Wound Classification System)and peripheral vasculopathy not susceptible to revascularization. A total of 132 patients will be enrolled. Participants will be centrally randomized to receive traditional therapy alone (TT) or in association with LA. TT includes standard medication of ulcers, antiaggregant therapy and statins. LA will be performed with HELP system, for a total of 10 sessions in 9 weeks. The primary end-point of the study is ulcer healing; secondary endpoints include improvements of peripheral oxygenation, resolution of pain, reduction of circulating inflammatory markers, cardiovascular events during one year's follow-up. This clinical Study has been approved by local EC on 25 may 2011 (Study number 1953). TO BE NOTED: since diabetic patients in our "Diabetic-Foot UNIT" often presented foot ulcers more severe than class II Texas, a formal amendment has been submitted to EC for recruiting patients with diabetic foot ulcer of class III Texas. The amendment was already approved on 5 may 2012.
China Resolute Integrity 34/38 mm Study
Ischemic Heart DiseaseStenotic Coronary Lesion3 moreTo evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.
Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation...
Myocardial InfarctionCoronary Arteriosclerosis2 moreThe purpose of this study is to establish safety and feasibility of utilizing Adipose-Derived Stem and Regenerative Cells (ADRC's) in patients who have suffered a ST-elevation acute myocardial infarction.
The ENDEAVOR II Clinical Trial: The Medtronic Endeavor Drug Eluting Coronary Stent System in Coronary...
Coronary Artery DiseaseArterial Occlusive Diseases7 moreTo demonstrate the safety and efficacy of the Driver Coronary Stent coated with 10 mcg/mm ABT-578 compared to the uncoated Driver Stent for the treatment of single de novo lesions in native coronary arteries 2.25-3.5 mm in diameter.
Hostility Reduction Program to Improve Autonomic Regulation of the Heart
HostilityCoronary ArteriosclerosisIndividuals who experience high hostility levels may be more prone to developing coronary artery disease (CAD) than individuals who experience low hostility levels. This study will evaluate the effectiveness of a hostility reduction treatment program on the body's ability to regulate heart activity in individuals with high levels of hostility.
Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (F.A.M.E.)
Coronary ArteriosclerosisIn this multicenter, international study we are evaluating two approaches to determine which coronary artery narrowings require stent placement in patients with multivessel coronary artery disease. Patients will be randomized to an angiographic strategy, where only coronary angiography is used to determine which lesions to stent or to a pressure wire strategy where fractional flow reserve, an index measured with the pressure wire, will be used to determine which lesions to stent. The primary outcome will be major adverse cardiac events at 1 year. A secondary outcome will be cost-effectiveness.
Comparative Atorvastatin Pleiotropic Effects
Coronary ArteriosclerosisHypercholesterolemiaThe primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as compared to atorvastatin 10 mg daily in reducing C-reactive protein levels over a 26-week treatment period in subjects with documented coronary artery disease.
Vitamin E and C to Slow Progression of Common Carotid Artery Plaque Build-Up
Cardiovascular DiseasesCarotid Artery Diseases5 moreThis study will evaluate the effects of vitamin E supplementation in retarding the progression of common carotid artery intima-media thickening in African Americans.
VR Education in Patients Undergoing Coronary Angiography
Coronary ArteriosclerosisThe aim of this study is to compare standard education with VR augmented education in patients undergoing selective coronary angiography.
Aquatic Aerobic Training, Cardiorespiratory and Metabolic Variables in Coronary Artery Disease
ArteriosclerosisCoronaryAlthough approaches to reduce cardiovascular disease, coronary artery disease (CAD) remains the leading cause of mortality in the industrialized world. In order to reduce the deleterious effects of the atherosclerotic process, proposals for non-pharmacological treatment have been used, such as cardiac rehabilitation programs, with emphasis on exercise -based therapy. Traditionally aerobic exercises like biking, walking and jogging are conducted, however, alternative ways such as aquatic exercise training have been proposed, however, the cardiorespiratory adaptations in this population are not well documented in the literature. Thus, the aim of this study was to evaluate the effects of aquatic aerobic training (AAT) on body composition, autonomic modulation of heart rate (HR) and cardiorespiratory and metabolic variables in patients with CAD. This was a longitudinal clinical trial with a sample allocated for convenience, in which twenty-one patients were male, with a diagnosis of CAD, which were divided into control group (CG were studied, n=8), who was only assessed, and training group (TG, n=13). All patients underwent assessment of body composition, heart rate variability (HRV) at rest in the supine posture, and cardiopulmonary exercise testing (CPET), performed before and after the AAT program. The training protocol consisted of three sessions per week on alternate days for 16 weeks, totaling 48 sessions, which had lasted approximately one hour. The exercise intensity was prescribed between 80 and 110% of the first ventilatory threshold (VT1) obtained in CPET. Given that these parameters represent risk markers for cardiovascular events in the population studied, the results suggest that the AAT proposed in this study may be an important therapeutic strategy to be incorporated into cardiac rehabilitation programs.