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Stroke prevention of thoracoscopic left atrial appendage clipping in patients with non-valvular atrial fibrillation at high risk of stroke and bleeding: study protocol for a non-randomised controlled clinical trial
Introduction Non-valvular atrial fibrillation (NVAF) is a high-risk factor for ischaemic stroke. The 2016 European Society of Cardiology Atrial Fibrillation Management guidelines recommend oral anticoagulants (OACs) to prevent stroke in men with CHA2DS2-VASc scores ≥2 and women ≥3. However, in patients with a high risk of stroke and a high risk of bleeding (HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly (> 65 years), Drugs/alcohol concomitantly) score≥3), OAC had a higher risk of bleeding. Left atrial appendage cl...
Source: BMJ Open - October 28, 2022 Category: General Medicine Authors: Ye, C., Han, X., Chen, Y., Liu, F., Ma, H., Yang, Y., Liu, Y., Hu, Q., Yao, Q., Xie, W., Xu, D. Tags: Open access, Surgery Source Type: research

Protocol for Home-Based Solution for Remote Atrial Fibrillation Screening to Prevent Recurrence Stroke (HUA-TUO AF Trial): a randomised controlled trial
The objective of the study was to explore the use of long-term home-based ECG monitoring for AF detection and stroke prevention in patients with a history of stroke. Methods and analysis This prospective, randomised, open-label trial with blinded endpoint adjudication aimed to evaluate the efficacy of long-term home-based ECG monitoring for AF detection and stroke prevention in a 24-month period. Patients aged >18 years with a history of ischaemic stroke will be stratified according to the time from the index ischaemic stroke: <1, 1–3 and >3 years and then randomised in 1:1 to (1) home-based AF screening an...
Source: BMJ Open - July 15, 2022 Category: General Medicine Authors: Wong, C. K., Hai, J. J., Lau, Y.-M., Zhou, M., LUI, H.-W., Lau, K. K., Chan, K.-H., Mok, T. M., Liu, Y., Feng, Y., Tan, N., Tam, W.-C., Tam, K.-C., Feng, X., Zuo, M.-L., Yin, L.-X., Tan, J., Zhang, W.-J., Jiang, X., Huang, X., Ye, J., Liang, Y., Jiang, W. Tags: Open access, Cardiovascular medicine Source Type: research

Correction: Stroke prevention of thoracoscopic left atrial appendage clipping in patients with non-valvular atrial fibrillation at high risk of stroke and bleeding: study protocol for a non-randomised controlled clinical trial
This article has been corrected since it was published online. The affiliation numbers 1 and 2 have been merged and updated to "Department of Cardiac Surgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China".
Source: BMJ Open - June 1, 2023 Category: General Medicine Tags: Open access Correction Source Type: research

Protocol for validating cardiovascular and cerebrovascular ICD-9-CM codes in healthcare administrative databases: the Umbria Data Value Project
Introduction Administrative healthcare databases can provide a comprehensive assessment of the burden of diseases in terms of major outcomes, such as mortality, hospital readmissions and use of healthcare resources, thus providing answers to a wide spectrum of research questions. However, a crucial issue is the reliability of information gathered. Aim of this protocol is to validate International Classification of Diseases, 9th Revision—Clinical Modification (ICD-9-CM) codes for major cardiovascular diseases, including acute myocardial infarction (AMI), heart failure (HF), atrial fibrillation (AF) and stroke. Method...
Source: BMJ Open - March 29, 2017 Category: Journals (General) Authors: Cozzolino, F., Abraha, I., Orso, M., Mengoni, A., Cerasa, M. F., Eusebi, P., Ambrosio, G., Montedori, A. Tags: Open access, Cardiovascular medicine, Health informatics, Health services research, Public health Protocol Source Type: research

Rationale design and efficacy of a smartphone application for improving self-awareness of adherence to edoxaban treatment: study protocol for a randomised controlled trial (adhere app)
This study was approved by the Seoul National University Bundang Hospital Institutional Review Board and will be conducted according to the principles of the Declaration of Helsinki. The study results will be published in a reputable journal. Trial registration number KCT0004754.
Source: BMJ Open - April 27, 2022 Category: General Medicine Authors: Kim, I.-C., Lee, J. H., Choi, D.-J., Park, S.-J., Lee, J.-H., Park, S. M., Kim, M., Kim, H.-L., Lee, S., Kim, I. J., Choi, S., Bang, J., Ali, B., Hussain, M., Ali, T., Lee, S. Tags: Open access, Cardiovascular medicine Source Type: research

Identifying postoperative atrial fibrillation in cardiac surgical patients posthospital discharge, using iPhone ECG: a study protocol
This study determines feasibility and impact of a self-surveillance programme to identify recurrence of postoperative AF in the month of posthospital discharge. Methods and analysis This is a feasibility study, using a cross-sectional study design, of self-screening for AF using a hand-held single-lead iPhone electrocardiograph device (iECG). Participants will be recruited from the cardiothoracic surgery wards of the Royal North Shore Hospital and North Shore Private Hospital, Sydney, Australia. Cardiac surgery patients admitted in sinus rhythm and experiencing a transient episode of postoperative AF will be eligible for ...
Source: BMJ Open - January 13, 2015 Category: Journals (General) Authors: Lowres, N., Freedman, S. B., Gallagher, R., Kirkness, A., Marshman, D., Orchard, J., Neubeck, L. Tags: Open access, Cardiovascular medicine, Public health Protocol Source Type: research

Symptom burden, Metabolic profile, Ultrasound findings, Rhythm, neurohormonal activation, haemodynamics and health-related quality of life in patients with atrial Fibrillation (SMURF): a protocol for an observational study with a randomised interventional component
Introduction Atrial fibrillation (AF) is the most common cardiac arrhythmia, with an estimated prevalence of 1.5–2%. It is an independent risk factor for ischaemic stroke and is estimated to cause about 20–25% of all stroke cases. AF has a great impact on health-related quality of life (HRQoL); however, one unresolved issue related to AF is the wide variation in its symptoms. Methods and analysis The symptom burden, metabolic profile, ultrasound findings, rhythm, neurohormonal activation, haemodynamics and HRQoL in patients with AF (Symptom burden, Metabolic profile, Ultrasound findings, Rhythm, neurohormonal ...
Source: BMJ Open - December 21, 2015 Category: Journals (General) Authors: Charitakis, E., Walfridsson, U., Nyström, F., Nylander, E., Strömberg, A., Alehagen, U., Walfridsson, H. Tags: Open access, Cardiovascular medicine, Medical management Protocol Source Type: research

Comparative effectiveness and safety of oral anticoagulants for atrial fibrillation in real-world practice: a population-based cohort study protocol
Introduction Anticoagulants are arguably the most important drug family of all, based on the frequency and duration of their use, and the clinical importance and frequency of benefits and harms. Several direct acting oral anticoagulants (DOACs) have recently joined warfarin for the treatment of atrial fibrillation, with a resultant significant expansion in use of oral anticoagulants (OACs). Our objectives are to compare safety and effectiveness of DOACs versus warfarin in a full population where anticoagulation management is good and to identify which types of patients do better with DOACs versus warfarin and vice versa. ...
Source: BMJ Open - November 23, 2016 Category: Journals (General) Authors: Holbrook, A., Dormuth, C., Morrow, R., Lee, A., Troyan, S., Li, G., Pullenyegum, E. Tags: Open access, Cardiovascular medicine, Pharmacology and therapeutics Protocol Source Type: research

Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER): protocol for a prospective observational nationwide study
Introduction Atrial fibrillation (AF) is a prevalent disease considerably contributing to the worldwide cardiovascular burden. For patients at high thromboembolic risk (CHA2DS2-VASc ≥3) and not suitable for chronic oral anticoagulation, owing to history of major bleeding or other contraindications, left atrial appendage occlusion (LAAO) is indicated for stroke prevention, as it lowers patient’s ischaemic burden without augmentation in their anticoagulation profile. Methods and analysis Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in nonvalvular Atrial fibrillatioN DiseasE Registry (S...
Source: BMJ Open - September 21, 2022 Category: General Medicine Authors: Kowalewski, M., Wanha, W., Litwinowicz, R., Kołodziejczak, M., Pasierski, M., Januszek, R., Kuzma, Łukasz, Grygier, M., Lesiak, M., Kapłon-Cieslicka, A., Reczuch, K., Gil, R., Pawłowski, T., Bartus, K., Dobrzycki, S., Lorusso, Tags: Open access, Cardiovascular medicine Source Type: research

wEight chanGes, caRdio-mEtabolic risks and morTality in patients with hyperthyroidism (EGRET): a protocol for a CPRD-HES linked cohort study
Introduction Hyperthyroidism is a common condition affecting up to 3% of the UK population. Treatment improves symptoms and reduces the risk of atrial fibrillation and stroke that contribute to increased mortality. The most common symptom is weight loss, which is reversed during treatment. However, the weight regain may be excessive, contributing to increased risk of obesity. Current treatment options include antithyroid drugs, radioiodine and thyroidectomy. Whether there are differences in either weight change or the long-term cardiometabolic risk between the three treatments is unclear. Methods and analysis The study wi...
Source: BMJ Open - October 1, 2021 Category: General Medicine Authors: Torlinska, B., Hazlehurst, J. M., Nirantharakumar, K., Thomas, G. N., Priestley, J. R., Finnikin, S. J., Saunders, P., Abrams, K. R., Boelaert, K. Tags: Open access, Diabetes and Endocrinology Source Type: research

Rationale and design of a prospective study evaluating population pharmacokinetics and pharmacodynamics of rivaroxaban in Chinese patients with non-valvular atrial fibrillation
Introduction Rivaroxaban is one of the most commonly used non-vitamin K antagonists for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Different individual exposures exist for Asian and non-Asian populations, and dose selection is different for Japanese and non-Japanese subjects. Few studies have investigated the pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in Chinese patients and provided a solid reference for dose selection and individualised therapy. Methods and analysis This is a single-centre prospective study. Rivaroxaban-treated Chinese NVAF patients will be recruited ...
Source: BMJ Open - June 3, 2022 Category: General Medicine Authors: Liu, X.-Q., Zhang, Y.-F., Ding, H.-Y., Yan, M.-M., Zhong, M.-K., Ma, C.-L. Tags: Open access, Pharmacology and therapeutics Source Type: research

Bi-atrial versus left atrial ablation for patients with rheumatic mitral valve disease and non-paroxysmal atrial fibrillation (ABLATION): rationale, design and study protocol for a multicentre randomised controlled trial
Introduction Atrial fibrillation (AF) is common in patients with rheumatic mitral valve disease (RMVD) and increase the risk of stroke and death. Bi-atrial or left atrial ablation remains controversial for treatment of AF during mitral valve surgery. The study aims to compare the efficacy and safety of bi-atrial ablation with those of left atrial ablation among patients with RMVD and persistent or long-standing persistent AF. Methods and analysis The ABLATION trial (Bi-atrial vs Left Atrial Ablation for Patients with RMVD and Non-paroxysmal AF) is a prospective, multicentre, randomised controlled study. The trial will ran...
Source: BMJ Open - November 29, 2022 Category: General Medicine Authors: Yu, C., Li, H., Wang, Y., Chen, S., Zhao, Y., Zheng, Z. Tags: Open access, Cardiovascular medicine Source Type: research

Registry for Evaluating Healthy Life Expectancy and Long-Term Outcomes after Catheter Ablation of Atrial Fibrillation in the Very Elderly (REHEALTH AF) study: rationale and design of a prospective, multicentre, observational, comparative study
Introduction Data are lacking on the extent to which patients with non-valvular atrial fibrillation (AF) who are aged ≥80 years benefit from ablation treatment. The question pertains especially to patients’ postablation quality of life (QoL) and long-term clinical outcomes. Methods and analysis We are initiating a prospective, registry-based, multicentre observational study that will include patients aged ≥80 years with non-valvular AF who choose to undergo treatment by catheter ablation and, for comparison, such patients who do not choose to undergo ablation (either according to their physician’s advice...
Source: BMJ Open - February 15, 2023 Category: General Medicine Authors: Okumura, Y., Nagashima, K., Watanabe, R., Yokoyama, K., Kato, T., Fukaya, H., Hayashi, H., Nakahara, S., Shimizu, W., Iwasaki, Y.-k., Fujimoto, Y., Mukai, Y., Ejima, K., Otsuka, T., Suzuki, S., Murakami, M., Kimura, M., Harada, M., Koyama, J., Okamatsu, H Tags: Open access, Cardiovascular medicine Source Type: research

Atorvastatin and the influence on postoperative atrial fibrillation after surgical aortic valve replacement (STARC) in adults at Odense University Hospital, Denmark: study protocol for a randomised controlled trial
Introduction Atrial fibrillation (AF) is the most common postoperative complication after surgical aortic valve replacement (SAVR) and occurs in up to 50% of the patients. Development of postoperative AF (POAF) is associated with a 2–3 fold increased risk of adverse events, including stroke, myocardial infarction and death. Several studies have implied that prophylactic Atorvastatin therapy could prevent POAF in patients undergoing coronary artery bypass graft. These studies suggest that Atorvastatin has rapid and significant pleiotropic actions that reduce the risk of POAF. However, prophylactic treatment with stati...
Source: BMJ Open - May 10, 2023 Category: General Medicine Authors: Krasniqi, L., Brandes, A., Mortensen, P. E., Dahl, J. S., Gerke, O., Ali, M., Riber, L. P. S. Tags: Open access, Cardiovascular medicine Source Type: research