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临床试验/NCT04090918
NCT04090918撤回不适用

Novel Methods for Characterizing Patients With Post-operative Atrial Fibrillation Secondary to Abdominal Surgery (A SECAFIB-SURG Sub-study)

Frederiksberg University Hospital1 个研究点 分布在 1 个国家开始时间: 2021年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Number of patients with abnormal left atrial strain

研究概览

简要总结

Purpose The primary purpose of the current project is to characterize unselected patients undergoing surgery developing post-operative atrial fibrillation (POAF), ultimately leading to a new risk-stratification model.

Background and rationale According to rather scarce existing reports, it is estimated that 10% will develop POAF following abdominal surgery. It remains a challenge for the clinicians to predict which patients are at risk. POAF can be difficult to diagnose, as symptoms are often vague. Hence, the diagnosis may remain underreported leaving many patients without adequate treatment. Untreated atrial fibrillation is associated with increased morbidity and mortality, especially due to an increased risk of ischemic stroke.

Methods Three-hundred adult patients admitted for surgery at the Digestive Disease Center at Bispebjerg Hospital will be examined by heart rhythm monitoring during hospitalization, i.e. pre-, peri- and postoperatively in the main SECAFIB-SURG study. Twenty study participants who develop POAF and 20 without POAF matched with these on sex, age and co-morbidity, will undergo additional cardiovascular examinations three months after surgery in the current sub-study. All patients will be followed for at least one year after surgery. The study is scheduled for completion within two years, commencing in January 2020.

Perspective Creating a POAF risk-stratification model for patients undergoing abdominal surgery, could ensure timely diagnosis and treatment, hence, preventing complications associated with POAF.

详细描述

Background and rationale Post-operative AF (POAF) appears to be common in relation to abdominal surgery affecting between 8% and 18%, however the incidence is not well reported,1 and the SECAFIB-SURG study aims at reporting this.

A number of risk-stratification models exist in the general population and in cardiac surgery patients, but it remains challenging to predict which patients will develop POAF in non-cardiac surgery patients.2-5 Diagnosing POAF is important, as recent data from the Framingham population suggest that secondary AF (AF occurring during a concomitant medical condition, e.g. surgery) is not a benign condition.6,7 Studies have found an association between POAF in relation to non-cardiac surgery and increased risk of post-operative mortality and stroke.8-10 Despite this, the current perception is that POAF is self-limiting and merely a result of the physiological stresses of surgery, why continuous anti-coagulation and referral for a cardiologist is not necessarily recommended.11-13 Well-known factors associated with AF in the general population is age, hypertension, heart failure, myocardial infarction, heart valve disease and diabetes.14 In general surgery important risk factors of AF is age (age 65-74, OR 2.08; age >85, OR 3.56), hypertension (OR 3.66), heart failure (OR 1.64), thyroid disease (OR 6.29), laparotomy (vs laparoscopy, OR 3.30) and duration of surgery (> 600 min, OR 1.38).1 The pathophysiology of AF is however incompletely comprehended.14-16 Structural remodelling of the atria and electrical pathways, oxidative stress, inflammation, calcium overload, myofibroblast activation and microRNAs are suspected implicated in AF initiation and progression.14-17 Improved understanding of the pathophysiology of AF and improved diagnostic tools for predicting POAF is needed. In the current study, blood samples will focus on markers of cardiac surcharge (troponins and natriuretic peptide)18,19, inflammation20-22 and microRNAs associated with AF.23-25 Urine samples will focus on oxidative stress markers.22,26,27 Electrocardiogram (ECG) will focus on short and prolonged p-wave, and p-wave terminal force in lead V1 (PTFV1) which are correlated with AF.28 Myovista (HeartSciences, Southlake, Texas, USA) a novel type of ECG (wavECG) utilizing continues wavelet transform signal processing, appears to identify left ventricular diastolic dysfunction (LVDD),29 which is associated with AF in other studies.16,30-32 Finapres Nova (Enschede, The Netherlands) is a continuous blood pressure monitor which will be used for non-invasive hemodynamic monitoring, e.g. beat-to-beat cardiac output, stroke volume, cardiac contractility, left ventricular ejection time and total peripheral resistance.33 Oral glucose tolerance test performed during monitoring with Finapres might demask peripheral vascular dysfunction.34 Speckle-tracking and strain analysis of the left atrium (LA) by transthoracic echocardiography (TTE) is in some studies able improve AF risk-prediction.35-39 Cardiac magnetic resonance imaging (CMRI) with late gadolinium enhancement (LGE) has been used to quantify atrial structural remodelling, fibrosis and function, and has been used to improve prediction of favourable outcome of patients undergoing ablation for AF.40-43

Purpose The study aims at characterizing patients developing POAF by novel methods to improve risk stratification of patients undergoing abdominal surgery.

Methods Prospective, single-centre, case-control study of patients undergoing abdominal surgery.

The current study is a sub-study of SECAFIB-SURG. Study participants will be identified among those enrolled in the SECAFIB-SURG study (study ID: 68605) who have agreed to be contacted if they developed POAF or matched on age and gender with someone who did. POAF is defined as new-onset AF developing from surgery until discharge and diagnosed by specialists in Cardiology or Anaesthesiology on ECG or heart rhythm monitoring for at least 30 seconds duration or three recurrent episodes of AF. The Investigator (Department of Cardiology at Bispebjerg-Frederiksberg Hospital) will ensure signed informed consent.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion in the SECAFIB-surg study
  • Signed informed consent

排除标准

  • Ongoing inflammation or infection
  • Connective tissue disease
  • Active cancer diagnosis
  • Follow-up not possible

结局指标

主要结局

Number of patients with abnormal left atrial strain

时间窗: Three months after abdominal surgery

Left atrial strain abnormality as measured by transthoracic echocardiography

次要结局

  • Number of patients with clinical events after surgery(From surgery until 1 year after surgery)

研究者

发起方
Frederiksberg University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoffer Valdorff Madsen

Principal Investigator

Frederiksberg University Hospital

研究点 (1)

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