Search results for "endpoint"
showing 10 items of 437 documents
CA125 but not NT-proBNP predicts the presence of a congestive intrarenal venous flow in patients with acute heart failure
2021
Abstract Background Intrarenal venous flow (IRVF) measured by Doppler ultrasound has gained interest as a potential surrogate marker of renal congestion and adverse outcomes in heart failure. In this work, we aimed to determine if antigen carbohydrate 125 (CA125) and plasma amino-terminal pro-B-type natriuretic peptide (NT-proBNP) are associated with congestive IRVF patterns (i.e., biphasic and monophasic) in acute heart failure (AHF). Methods and results We prospectively enrolled a consecutive cohort of 70 patients hospitalized for AHF. Renal Doppler ultrasound was assessed within the first 24-h of hospital admission. The mean age of the sample was 73.5 ± 12.3 years; 47.1% were female, and…
Impact of overlapping on 1-year clinical outcomes in patients undergoing everolimus-eluting bioresorbable scaffolds implantation in routine clinical …
2016
Background Overlapping implantation of bioresorbable scaffolds (BRSs) are frequent in long coronary lesions. Its impact on clinical outcomes is unknown. Objective: To compare the clinical outcomes of patients treated with overlapping BRS with those patients treated with no-overlap BRS. Methods: We analyzed the 1-year clinical outcomes of 1,477 patients treated with BRS in the GHOST-EU registry, according to the implantation of overlapping BRS. Primary endpoint was patient oriented composite endpoint (PoCE) of: all-cause death, any myocardial infarction (MI) and any repeated revascularization. Scaffold thrombosis, according to Academic Research Consortium definition, was also analyzed. Resul…
Antihypertensive treatment: should it be titrated to blood pressure reduction or to target organ damage regression?
2005
PURPOSE OF REVIEW The success of an antihypertensive treatment is difficult to estimate by the extent of blood pressure reduction alone. Above and beyond blood pressure values in an individual patient, it is necessary to monitor the impact of antihypertensive treatment on the development or regression of hypertension-induced early end-organ damage. The intermediate objectives or surrogate endpoints may provide additional valuable information about the level of success of a given therapy in a particular patient. Moreover, monitoring intermediate objectives may provide scientific evidence for delineating the best antihypertensive treatment. RECENT FINDINGS The importance of assessing left ven…
LAight® Therapy Significantly Enhances Treatment Efficacy of 16 Weeks of Topical Clindamycin Solution in Hurley I and II Hidradenitis Suppurativa: Re…
2021
<b><i>Background:</i></b> Hidradenitis suppurativa (HS) is a chronic, inflammatory, burdensome skin disease where medical first-line treatment is still limited to long-term, topical and/or systemic antibiotics. The RELIEVE study aimed at evaluating the efficacy of LAight® therapy – a combination of intense pulsed light and radiofrequency – as an adjunct treatment to first-line therapies in Hurley stage I and II HS. <b><i>Methods:</i></b> The RELIEVE study was performed as a two-period multicenter randomized controlled trial with blinded assessment. For period A from week 0 to week 16, the 88 participating subjects were randomized into either a…
Invasive Versus Conservative Strategy in Frail Patients With NSTEMI: The MOSCA-FRAIL Clinical Trial Study Design
2019
Abstract Introduction and objectives Although clinical guidelines recommend invasive management in non–ST-segment elevation myocardial infarction (NSTEMI), this strategy is underused in frail elderly patients in the real world. Furthermore, these patients are underrepresented in clinical trials and therefore the evidence is scarce. Our hypothesis is that an invasive strategy will improve prognosis in elderly frail patients with NSTEMI . Methods This will be a prospective, multicenter, randomized trial, in which the conservative and invasive strategies will be compared in patients meeting all of the following inclusion criteria: NSTEMI diagnosis, age ≥ 70 years, and frailty defined by a cate…
One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy
2020
Background: Cataract surgery is the most common operation performed worldwide. A fixed topical corticosteroid-antibiotic combination is usually prescribed in clinical practice for 2 or more weeks to treat post surgical inflammation and prevent infection. However, this protracted schedule may increase the incidence of corticosteroid-related adverse events and notably promote antibiotic resistance. Methods: This International, multicentre, randomized, blinded-assessor, parallel-group clinical study evaluated the non-inferiority of 1-week levofloxacin/dexamethasone eye drops, followed by 1-week dexamethasone alone, vs. 2-week gold-standard tobramycin/dexamethasone (one drop QID for all schedul…
Rationale and design of the EMBRACE STEMI Study: A phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability …
2012
Background Although significant efforts have been made to improve ST-segment elevation myocardial infarction (STEMI) outcomes by reducing symptom-onset-to-reperfusion times, strategies to decrease the clinical impact of ischemic reperfusion injury have demonstrated limited success. Bendavia, an intravenously administered mitochondrial targeting peptide, has been shown to reduce myocardial infarct size and attenuate coronary no-reflow in experimental modelswhen given before reperfusion. Design The EMBRACE STEMI study is a phase 2a, randomized, double-blind, placebo-controlled trial enrolling 300 patients with a first-time anterior STEMI and an occluded proximal or mid–left anterior descendin…
Multicenter experience with the antegrade fenestration and reentry technique for chronic total occlusion recanalization
2020
Objectives We aimed to evaluate the efficacy and safety of antegrade fenestration and reentry (AFR) for chronic total occlusion (CTO) recanalization in a multicenter registry. Background Adoption of antegrade dissection/reentry (ADR) for CTO recanalization has been limited, and novel ADR techniques are needed. Methods AFR involves the balloon-induced creation of multiple fenestrations between the false and true lumen. A targeted true lumen reentry is subsequently achieved with a low tip-load polymer-jacketed guidewire. Following the initial description and dissemination of AFR, patients undergoing AFR-based CTO recanalization at nine centers were included in the present registry. Study endp…
Evaluation of the Oxiris Membrane in Cardiogenic Shock Requiring Extracorporeal Membrane Oxygenation Support: Study Protocol for a Single Center, Sin…
2021
Background: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is the rescue treatment proposed to patients with refractory cardiogenic shock. The VA-ECMO implantation promotes inflammation and ischemia-reperfusion injuries through the VA-ECMO flow, causing digestive mucosa barrier disrupture and inducing translocation of bacterial wall components—Lipopolysaccharides (LPS) with further inflammation and circulatory impairment. LPS is a well-studied surrogate indicator of bacterial translocation. Oxiris membrane is a promising and well-tolerated device that can specifically remove LPS. The main study aim is to compare the LPS elimination capacity of Oxiris membrane vs. a non-absorban…
Is time to joint replacement a valid outcome measure in clinical trials of drugs for osteoarthritis?
2003
The rate of radiographic joint space narrowing is commonly used today as a structural outcome measure in clinical trials evaluating potential disease-modifying drugs in patients with hip osteoarthritis, but this results in a continuous variable. Among the methods proposed to circumvent this problem, it has been suggested that the incidence of total hip arthoplasty (THA) provides a hard outcome measure. It is a dichotomized variable, easy to measure and sensitive to change, with acceptable intrinsic validity. However, because this measure is limited by the variability of factors underlying the decision to perform surgery and the length of waiting lists, it has been suggested that time to ful…