Search results for "endpoint"
showing 10 items of 437 documents
Early determination of homocysteine levels in acute coronary syndromes, is it an independent prognostic factor?
2004
Abstract Introduction Increased concentrations of homocysteine (tHcy) are considered a potentially modifiable risk factor for coronary heart disease. The relationship between plasma homocysteine and prognosis has been less well studied. The aim of this study was to examine a possible relationship between the homocysteine levels in admission and all cause mortality in subjects presenting with non-ST segment elevation (NSTE) acute coronary syndrome. Methods We studied 854 patients with suspected NSTE acute coronary syndrome admitted consecutively to our institution, tHcy was determined at a median of 3 days from enrolment and was analyzed in tertiles together with classical risk factors and o…
Arrhythmia Termination Versus Elimination of Dormant Pulmonary Vein Conduction as a Procedural End Point of Catheter Ablation for Paroxysmal Atrial F…
2015
Background— Pulmonary vein isolation (PVI) is still associated with a substantial number of arrhythmia recurrences in paroxysmal atrial fibrillation (AF). This prospective, randomized study aimed to compare 2 different procedural strategies. Methods and Results— A total of 152 patients undergoing de novo ablation for paroxysmal AF were randomized to 2 different treatment arms. The procedure in group A consisted of PVI exclusively. In this group, all isolated PVs were challenged with adenosine to reveal and ablate dormant conduction. In group B, PVI was performed with the patient either in spontaneous or in induced AF. If AF did not terminate with PVI, ablation was continued by targeting ex…
Extended-release guanfacine hydrochloride in 6-17-year olds with ADHD: a randomised-withdrawal maintenance of efficacy study.
2015
Background Extended-release guanfacine hydrochloride (GXR), a selective α2A-adrenergic agonist, is a nonstimulant medication for attention-deficit/hyperactivity disorder (ADHD). This phase 3, double-blind, placebo-controlled, randomised-withdrawal study evaluated the long-term maintenance of GXR efficacy in children/adolescents with ADHD. Methods Children/adolescents (6–17 years) with ADHD received open-label GXR (1–7 mg/day). After 13 weeks, responders were randomised to GXR or placebo in the 26-week, double-blind, randomised-withdrawal phase (RWP). The primary endpoint was the percentage of treatment failure (≥50% increase in ADHD Rating Scale version IV total score and ≥2-point increase …
Advanced interatrial block predicts new-onset atrial fibrillation and ischemic stroke in patients with heart failure: The “Bayes' Syndrome-HF” study
2018
Advanced interatrial block (IAB) is characterized by a prolonged (≥120 ms) and bimodal P wave in the inferior leads. The association between advanced IAB and atrial fibrillation (AF) is known as “Bayes' Syndrome”, and there is scarce information about it in heart failure (HF). We examined the prevalence of IAB and whether advanced IAB could predict new-onset AF and/or stroke in HF patients. Methods and results: The prospective observational “Bayes' Syndrome-HF” study included consecutive outpatients with chronic HF. The primary endpoints were new-onset AF, ischemic stroke, and the composite of both. A secondary endpoint included all-cause death alone or in combination with the primary endpo…
A Popular myth - low-histamine diet improves chronic spontaneous urticaria - fact or fiction?
2016
Background Chronic spontaneous urticaria (CsU) is a frequent dermatological disease that might last for months or years with high impact on quality of life. Known causes are autoreactive phenomena, infections or intolerances, rarely IgE-mediated allergies. One third of CsU patients benefit from a low-pseudoallergen diet. Additionally, it is often discussed, that reducing histamine ingestion alone might improve clinical symptoms and quality of life in CsU-patients despite the uncertain role of the histamine-degrading enzyme diamine oxidase (DAO). Objective Aim of this study is to investigate the impact of low-histamine diet on symptoms and quality of life in patients with CsU. Methods Patien…
Usefulness of delta troponin for diagnosis and prognosis assessment of non-ST-segment elevation acute chest pain.
2014
The additional diagnostic and prognostic information provided by delta high-sensitivity troponin T (hs-cTnT) in patients with acute chest pain and hs-cTnT elevation remains unclear.The study group consisted of 601 patients presenting at the emergency department with non-ST-segment elevation acute chest pain and hs-cTnT elevation after two determinations (admission and within the first six hours). Maximum hs-cTnT and delta hs-cTnT (absolute or percentage change between the two measurements) were considered. Cutoff values were optimized using the quartile distribution for the endpoints. The endpoints were diagnostic (significant stenosis in the coronary angiogram) and prognostic (death or rec…
Definitions and Clinical Trial Design Principles for Coronary Artery Chronic Total Occlusion Therapies: CTO-ARC Consensus Recommendations.
2021
Over the past 2 decades, chronic total occlusion (CTO) percutaneous coronary intervention has developed into its own subspecialty of interventional cardiology. Dedicated terminology, techniques, devices, courses, and training programs have enabled progressive advancements. However, only a few randomized trials have been performed to evaluate the safety and efficacy of CTO percutaneous coronary intervention. Moreover, several published observational studies have shown conflicting data. Part of the paucity of clinical data stems from the fact that prior studies have been suboptimally designed and performed. The absence of standardized end points and the discrepancy in definitions also prevent…
Aflibercept in Combination With FOLFIRI as First-line Chemotherapy in Patients With Metastatic Colorectal Cancer (mCRC): A Phase II Study (FFCD 1302)
2020
Abstract Background FOLFIRI (irinotecan, 5-fluorouracil, and leucovorin) + aflibercept improves median overall survival (OS) and progression-free survival (PFS) in patients with previously treated metastatic colorectal cancer (mCRC). Our aim was to investigate efficacy and tolerability of this combination in the first line. Patients and Methods Patients with untreated documented mCRC received aflibercept plus FOLFIRI every 14 days until progression or unacceptable toxicity in an open, phase II single-arm, multicenter trial. The primary endpoint was the 6-month PFS rate. Secondary endpoints were OS and tolerability. A 2-step Simon design was used with H0: 55% and H1= 75%. Data were analyzed …
The influence of hemoglobin A1c levels on cardiovascular events and all-cause mortality in people with diabetes over 70 years of age. A prospective s…
2019
Abstract Aim Glycated hemoglobin A1c (HbA1c) is a reliable risk factor of cardiovascular diseases in diabetic patients, but information about this relationship in elderly patients is scarce. The aim of this study is to analyze, the relationship between HbA1c levels and the risk of mayor adverse cardiovascular events (MACE) in patients with diabetes over 70 years. Methods Prospective study of subjects with diabetes using electronic health records from the universal public health system in the Valencian Community, Spain, 2008–2012. We included men and women aged ≥ 70 years with diabetes who underwent routine health examinations in primary care. Primary endpoint was the incidence of MACE: all-…
Predictive biomarkers for death and rehospitalization in comorbid frail elderly heart failure patients.
2018
Background Heart failure (HF) is associated with a high rate of readmissions within 30 days post-discharge and in the following year, especially in frail elderly patients. Biomarker data are scarce in this high-risk population. This study assessed the value of early post-discharge circulating levels of ST2, NT-proBNP, CA125, and hs-TnI for predicting 30-day and 1-year outcomes in comorbid frail elderly patients with HF with mainly preserved ejection fraction (HFpEF). Methods Blood samples were obtained at the first visit shortly after discharge (4.9 ± 2 days). The primary endpoint was the composite of all-cause mortality or HF-related rehospitalization at 30 days and at 1 year. All-cause mo…