Abstract:
BACKGROUND:CSL112 (apolipoprotein A-I [human]) is a plasma-derived apolipoprotein A-I developed for early reduction of cardiovascular risk following an acute myocardial infarction (AMI). The safety of CSL112 among AMI subjects with moderate, stage 3 chronic kidney disease (CKD) is unknown. METHODS:CSL112_2001, a multicenter, placebo-controlled, parallel-group, double-blind, randomized phase 2 trial, enrolled patients with moderate CKD within 7 days following AMI. Enrollment was stratified on the basis of estimated glomerular filtration rate and presence of diabetes requiring treatment. Patients were randomized in a 2:1 ratio to receive 4 weekly infusions of CSL112 6 g or placebo. The co-primary safety end points were renal serious adverse events (SAEs) and acute kidney injury, defined as an increase ≥26.5 μmol/L in baseline serum creatinine for more than 24 hours, during the treatment period. RESULTS:A total of 83 patients were randomized (55 CSL112 vs 28 placebo). No increase in renal SAEs was observed in the CSL112 group compared with placebo (CSL112 = 1 [1.9%], placebo = 4 [14.3%]). Similarly, no increase in acute kidney injury events was observed (CSL112 = 2 [4.0%], placebo = 4 [14.3%]). Rates of other SAEs were similar between groups. CSL112 administration resulted in increases in ApoA-I and cholesterol efflux similar to those observed in patients with AMI and normal renal function or stage 2 CKD enrolled in the ApoA-I Event Reducing in Ischemic Syndromes I trial. CONCLUSIONS:These results demonstrate the acceptable safety of the 6-g dose of CSL112 among AMI subjects with moderate stage 3 CKD and support inclusion of these patients in a phase 3 cardiovascular outcomes trial powered to assess efficacy.
journal_name
Am Heart Jjournal_title
American heart journalauthors
Gibson CM,Kerneis M,Yee MK,Daaboul Y,Korjian S,Mehr AP,Tricoci P,Alexander JH,Kastelein JJP,Mehran R,Bode C,Lewis BS,Mehta R,Duffy D,Feaster J,Halabi M,Angiolillo DJ,Duerschmied D,Ophuis TO,Merkely Bdoi
10.1016/j.ahj.2018.11.008subject
Has Abstractpub_date
2019-02-01 00:00:00pages
81-90eissn
0002-8703issn
1097-6744pii
S0002-8703(18)30324-7journal_volume
208pub_type
杂志文章,多中心研究,随机对照试验abstract::The acute hemodynamic and electrophysiologic effects of flecainide in tachycardia-induced ventricular dysfunction were investigated using an animal model. Seven swine were initially (CON) evaluated by echocardiography and then by right heart catheterization and provocative electrical ventricular stimulation both befor...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/0002-8703(91)90018-d
更新日期:1991-06-01 00:00:00
abstract:BACKGROUND:Aortopulmonary collaterals (APCs) are frequently observed before and after the Fontan procedure. However, the mechanism of the development of APCs is unknown. We hypothesized that one or several antiangiogenic and/or angiogenic growth factors might play a role in the development of APCs. METHODS:Eighty-five...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/j.ahj.2007.03.009
更新日期:2007-06-01 00:00:00
abstract:BACKGROUND:Dobutamine and exercise echocardiography are accepted as tests of comparable efficacy for the diagnosis of coronary artery disease. Although dobutamine has been classified as "exercise simulating," the mechanisms of ischemia with dobutamine and exercise have not been well studied. This study sought to compar...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/s0002-8703(98)70183-8
更新日期:1998-07-01 00:00:00
abstract::Affected members of early coronary pedigrees in Utah are at markedly increased risk for the development of clinical coronary heart disease (CHD). The relationship between the presence of coronary risk factors and the severity of angiographic coronary artery disease (CAD) in 53 members of high-risk Utah pedigrees was e...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/0002-8703(92)90635-9
更新日期:1992-02-01 00:00:00
abstract:BACKGROUND:A substantial percentage of patients have undiagnosed diabetes. We investigated the demographic characteristics and cardiometabolic profiles of subjects with undiagnosed diabetes. METHODS:A cross-sectional study with nationally representative samples of 25490 subjects aged ≥ 20 years from the KHNANES 2008 t...
journal_title:American heart journal
pub_type: 杂志文章,多中心研究
doi:10.1016/j.ahj.2015.07.024
更新日期:2015-10-01 00:00:00
abstract:BACKGROUND:Heart failure still maintains a high mortality. Biomarkers reflecting different pathophysiological pathways are under evaluation to better stratify the mortality risk. The objective was to assess high-sensitivity cardiac troponin T (hs-cTnT) in combination with N-terminal pro-B type natriuretic peptide (NT-p...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/j.ahj.2012.03.004
更新日期:2012-05-01 00:00:00
abstract:BACKGROUND:Some pharmacist-managed anticoagulation services (PMAS) provide initial follow-up to patients on oral anticoagulant, who are transferred to their physician once they are stabilized. This may be as effective as and less expensive than long-term PMAS follow-up. METHODS:Once PMAS patients were stabilized and r...
journal_title:American heart journal
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.ahj.2008.02.009
更新日期:2008-07-01 00:00:00
abstract::Metoprolol or placebo was gradually withdrawn during 1 week in 115 patients participating in a 3-year, double-blind, postinfarction study. During the first month after withdrawal mental symptoms and increased cardiac symptoms occurred significantly more frequently in the metoprolol group. Disabling symptoms requiring ...
journal_title:American heart journal
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/0002-8703(84)90408-3
更新日期:1984-09-01 00:00:00
abstract::The purpose of this study was to determine the normal pattern and magnitude of mitral annular velocities in diastole by Doppler tissue imaging (DTI) and to assess whether this is altered in patients with left ventricular hypertrophy. Mitral annulus velocities were measured by DTI. Peak and time-velocity integral were ...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/s0002-8703(96)90183-0
更新日期:1996-05-01 00:00:00
abstract:BACKGROUND:Perflenapent injectable emulsion is a newer echocardiographic contrast agent that provides chamber opacification and improved endocardial border delineation. In >1000 patients tested, adverse effects have been minimal. However, previous studies have included few patients with congestive heart failure (CHF) o...
journal_title:American heart journal
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1067/mhj.2000.106612
更新日期:2000-06-01 00:00:00
abstract::In order to correlate the antiarrhythmic and electrophysiological effects of disopyramide phosphate during acute myocardial ischemia, we performed experiments in 17 mongrel dogs. Refractory periods obtained by the extrastimulus method and conduction times recorded from local electrograms were determined in potentially...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/0002-8703(79)90046-2
更新日期:1979-09-01 00:00:00
abstract::Thallium-201 redistribution pattern after exercise was related to rest and exercise left ventricular regional and global function, measured by radionuclide ventriculography, in 61 patients, 50 with coronary artery disease (CAD). Sixteen patients had exclusively transient thallium defects, suggesting ischemia: in this ...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/0002-8703(81)90608-6
更新日期:1981-06-01 00:00:00
abstract:BACKGROUND:Atrial fibrillation remains a frequent complication after heart surgery. The optimal strategy to treat the condition has not been established. Several retrospective studies have suggested that a primary rate-control strategy may be equivalent to a strategy that restores sinus rhythm. METHODS:Fifty patients ...
journal_title:American heart journal
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1067/mhj.2000.111104
更新日期:2000-12-01 00:00:00
abstract:BACKGROUND:Clinical trials have helped clarify the efficacy of clopidogrel for the treatment and prevention of vascular disease. Costs for its use exceeded $5.9 billion in 2005, making it the second greatest source of drug expenditure in the world. However, little is known about the appropriateness of that use. Overuse...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/j.ahj.2007.11.039
更新日期:2008-05-01 00:00:00
abstract:BACKGROUND:The LaFarge equation is the most commonly used equation to estimate oxygen consumption (Vo(2)) in patients of all ages with congenital heart disease, although it was generated in patients older than 3 years. We sought to determine the validity of the LaFarge equation in estimating Vo(2) in children younger t...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/j.ahj.2010.04.003
更新日期:2010-07-01 00:00:00
abstract::Cardiac arrhythmias arise from disturbances in the functioning of the specific ion channels that normally control excitation or from the functional expression of previously latent channels. Antiarrhythmic agents act by blocking the membrane sodium, potassium, and calcium channels, but no agent has exclusive action on ...
journal_title:American heart journal
pub_type: 杂志文章,评审
doi:10.1016/0002-8703(92)91072-9
更新日期:1992-04-01 00:00:00
abstract::The novel oral anticoagulants (NOACs) have rapidly emerged as an alternative therapy to warfarin. Several recent phase 3 randomized control trials have demonstrated the efficacy and safety of the NOACs in the treatment for patients with nonvalvular atrial fibrillation. As the NOACs are incorporated in clinical practic...
journal_title:American heart journal
pub_type: 杂志文章,评审
doi:10.1016/j.ahj.2014.12.008
更新日期:2015-03-01 00:00:00
abstract:BACKGROUND:The aim of the study was to describe the incidence and consequences of minor surgery after drug-eluting stent (DES) implantation. METHODS:The Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) Registry prospectively enrolled unselected patients undergoing percutaneous coronary intervention at 47 ...
journal_title:American heart journal
pub_type: 杂志文章,多中心研究
doi:10.1016/j.ahj.2010.09.028
更新日期:2011-02-01 00:00:00
abstract:BACKGROUND:Although age is the most important variable associated with death among patients with persistent ST-segment elevation, its impact on outcome among patients without persistent ST-segment elevation remains unknown. Moreover, the impact of age on the efficacy of antiplatelet therapy with eptifibatide is unknown...
journal_title:American heart journal
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0002-8703(00)90018-8
更新日期:2000-05-01 00:00:00
abstract:BACKGROUND:In China, low socioeconomic status (SES) may be a barrier for patients with coronary heart disease (CHD) to receive adequate treatment because of their inadequate access to health resources. This study aims to evaluate whether and to what extent SES is associated with the treatment of CHD patients. METHODS:...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/j.ahj.2008.12.009
更新日期:2009-04-01 00:00:00
abstract:BACKGROUND:Low heart rate recovery (HRR) at exercise test and the metabolic syndrome (MetS) are both predictors of cardiovascular morbidity and mortality. We studied in 75-year-old women and men, representative of the general population, the relationship between (1) HRR and the MetS, (2) HRR and the individual componen...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/j.ahj.2007.06.025
更新日期:2007-09-01 00:00:00
abstract:BACKGROUND:Congestive heart failure (CHF) and heart transplantation (HTX) are characterized by endothelial dysfunction as indicated by elevation of markers of endothelial function, including endothelin and von Willebrand factor (vWF). However, previous studies included both patients with idiopathic dilated cardiomyopat...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/s0002-8703(99)70505-3
更新日期:1999-03-01 00:00:00
abstract::Current evidence suggests that the pathogenesis of atrial fibrillation (AF) is multifactorial. The observation that AF, once present, alters the electrophysiologic properties of the atrial myocardium causing self-perpetuation of the arrhythmia raised the importance of electrical remodeling in its pathogenesis. Althoug...
journal_title:American heart journal
pub_type: 杂志文章,评审
doi:10.1016/j.ahj.2008.10.009
更新日期:2009-02-01 00:00:00
abstract::Recently, the theory that hyperinflammation is the body's primary response to potent stimulus has been challenged. Indeed, a deregulation of the immune system could be the cause of multiple organ failure. So far, clinicians have focused on the last steps of the inflammatory cascade. However, little attention has been ...
journal_title:American heart journal
pub_type: 杂志文章,评审
doi:10.1016/j.ahj.2008.07.008
更新日期:2008-12-01 00:00:00
abstract::The effects of cytochrome C, an electron carrier in the process of oxidative phosphorylation, on infarct size and regional left ventricular function after a coronary artery occlusion were investigated. Thus, in 30 dogs, 1 minute after left anterior descending coronary artery occlusion, 99mTc-labeled albumin microspher...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/0002-8703(87)90019-6
更新日期:1987-01-01 00:00:00
abstract:BACKGROUND:In the treatment of coronary artery disease, a "pro-healing" approach for prevention of in-stent restenosis and late stent thrombosis is intuitively favored over the use of cytotoxic or cytostatic drugs released from a drug-eluting stent (DES). Promoting accelerated endothelial coverage of the stent surface,...
journal_title:American heart journal
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.ahj.2009.07.022
更新日期:2009-10-01 00:00:00
abstract:BACKGROUND:Patients with diabetes have an increased incidence and severity of ischemic heart disease, which leads to an increased requirement for coronary revascularization. Comparative information regarding mode of revascularization--coronary artery bypass graft surgery surgery (CABG) or percutaneous coronary interven...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/j.ahj.2004.07.001
更新日期:2005-01-01 00:00:00
abstract:BACKGROUND:The diameter pulse waveforms (DPWs) are known to reflect the pressure waveforms at the target vessel. Our purpose was to clarify the usefulness of DPWs recorded noninvasively from the fetal inferior vena cava (IVC) for detecting cardiac function. METHODS:A paired ultrasonic phase-locked echo tracking system...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/j.ahj.2007.06.015
更新日期:2007-10-01 00:00:00
abstract:BACKGROUND:A shortcoming of the pediatric electrocardiogram (ECG) appears to be its inability to accurately detect left ventricular hypertrophy (LVH). This study prospectively assesses the usefulness of the pediatric ECG as a screening modality for LVH. METHODS:Concomitant echocardiograms and ECGs from a large cohort ...
journal_title:American heart journal
pub_type: 杂志文章,多中心研究
doi:10.1067/mhj.2003.15
更新日期:2003-04-01 00:00:00
abstract::To examine the recovery time of left atrial mechanical function after electrical cardioversion of atrial fibrillation, we recorded transmitral flow, pulmonary venous flow velocities, and interatrial septal motion during atrial systole within 24 hours (16 +/- 5 hours) and 10 days after cardioversion in 25 patients with...
journal_title:American heart journal
pub_type: 杂志文章
doi:10.1016/s0002-8703(96)90353-1
更新日期:1996-02-01 00:00:00