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Incidence of Post-operative Atrial Fibrillation Secondary to Abdominal Surgery (SECAFIB-SURG)

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ClinicalTrials.gov Identifier: NCT04090905
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Christoffer Valdorff Madsen, Frederiksberg University Hospital

Tracking Information
First Submitted Date September 13, 2019
First Posted Date September 16, 2019
Last Update Posted Date June 30, 2020
Actual Study Start Date June 13, 2020
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 16, 2019)
Incidence of new onset atrial fibrillation peri- and post-operatively [ Time Frame: From admission to surgery, during surgery, and until 1 year after surgery ]
Occurrence of atrial fibrillation on electrocardiogram or Holter monitoring
Original Primary Outcome Measures
 (submitted: September 13, 2019)
New onset atrial fibrillation peri- and post-operatively [ Time Frame: From admission to surgery, during surgery, and until 1 year after surgery ]
Occurrence of atrial fibrillation on electrocardiogram or Holter monitoring
Change History
Current Secondary Outcome Measures
 (submitted: September 16, 2019)
  • Incidence of clinical events after surgery [ Time Frame: From surgery until 1 year after surgery ]
    Clinical events defined as: reoperation; ischemic stroke or transient ischemic attack; all-cause mortality
  • Number of patients with abnormal p-wave indexes [ Time Frame: Before surgery ]
    Abnormal p-wave indexes on electrocardiogram
  • Number of patients with left ventricular diastolic dysfunction [ Time Frame: Before surgery ]
    Left ventricular diastolic dysfunction as measured on wavECG (Myovista)
Original Secondary Outcome Measures
 (submitted: September 13, 2019)
  • Post-surgery clinical events [ Time Frame: From surgery until 1 year after surgery ]
    i.e. reoperation; ischemic stroke or transient ischemic attack; all-cause mortality
  • Abnormal p-wave indexes [ Time Frame: Before surgery ]
    Abnormal p-wave indexes on electrocardiogram
  • Left ventricular diastolic dysfunction [ Time Frame: Before surgery ]
    Left ventricular diastolic dysfunction as measured on wavECG (Myovista)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Incidence of Post-operative Atrial Fibrillation Secondary to Abdominal Surgery
Official Title Incidence of Post-operative Atrial Fibrillation Secondary to Abdominal Surgery - A Single-centre, Prospective, Cohort Study
Brief Summary

Background and purpose Post-operative AF (POAF) is considered a phenomenon rather than a definite diagnosis and the current clinical guidelines have no specific recommendations regarding its management. Few prospective studies have been performed in non-cardiac conditions and consequences of POAF in patients without known heart disease is not well described. However, recent data suggest an association between POAF in relation to non-cardiac surgery and increased post-operative mortality and stroke. POAF in relation to abdominal surgery seems common (incidence: 8-18%); however, the true incidence is uncertain. The available studies are few, heterogenous and often methodologically inadequate. The study aims at reporting the true incidence of AF, and associated complications, in relation to abdominal surgery.

Material and methods Designed as a prospective, single-centre, cohort study of consecutive adult patients undergoing acute or elective abdominal surgery at Department of Abdominal Surgery at Bispebjerg Hospital. Patients who are pregnant or where follow-up is not possible will be excluded. Patients will be examined pre-operatively by ECG and signal processed surface ECG (wavECG). Heart rhythm monitoring will be worn from admission and until discharge (preferably ≥72 hour post-operatively). Examinations are repeated 90 days post-operatively. Additional follow-up will be based on patient charts for ≥12 months. Primary endpoint is occurrence/recurrence of AF. The study will include 300 patients.

Perspective If more thorough heart rhythm monitoring of patients undergoing abdominal surgery leads to identification of more patients with AF, routine continuous heart rhythm monitoring should be considered recommended in upcoming guidelines to prevent associated complications.

Detailed Description

Background and rationale Post-operative AF (POAF), i.e. new-onset AF that occurs secondarily to surgery is considered a phenomenon rather than a definite diagnosis, and continuous anti-coagulation is not recommended in AF of short duration and non-persistent AF.1,2 The most recent guidelines from the European and American Societies of Cardiology has no specific recommendation regarding management of secondary AF, though referral for an outpatient cardiology clinic can be considered if the condition is not self-limiting.3,4 Despite this, recent data from the Framingham population suggest that secondary AF is not a benign condition,5,6 and some studies have found POAF in relation to non-cardiac surgery to be associated with increased post-operative mortality and stroke.7-9 Currently few prospective studies have been performed in non-cardiac conditions and consequences of secondary AF in patients without known heart disease is not well described. POAF in relation to non-cardiac surgery is common with an average incidence of 10.94%.10 However, the true incidence of POAF in relation to non-cardiac surgery is uncertain, as the available studies are few, heterogenous and often methodologically inadequate.10 Different risk-stratification models exist, however it is still challenging to accurately predict which patients will develop AF both perioperatively and in the years following surgery.11-14 Important risk factors for developing POAF 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).10 The use of electrocardiogram (ECG) in risk stratification for AF and stroke is not yet incorporated in clinical guidelines. However, short and prolonged p-wave and p-wave terminal force in lead V1 (PTFV1) is correlated with AF.15 Myovista (HeartSciences, Southlake, Texas, USA) is a novel ECG utilizing continuous wavelet transform signal processing (wavECG) and can be used to prove left ventricular diastolic dysfunction (LVDD).16 LVDD is other studies associated with AF.17-20 These new biomarkers might improve identification of patients at risk of developing POAF.

Purpose The study aims at reporting the true incidence of AF, and associated complications, in relation to abdominal surgery. Concurrently, patients will be characterized by specialized ECG analysis and wavECG.

Methods Prospective, single-centre, cohort study of consecutive patients undergoing abdominal surgery. Patients will be identified among elective and acute referrals for Department of Abdominal Surgery at Bispebjerg-Frederiksberg Hospital. The Investigator (Department of Cardiology at Bispebjerg-Frederiksberg Hospital) will ensure signed informed consent prior to any study related examinations. Surgery will be performed at Department of Abdominal Surgery at Bispebjerg-Frederiksberg Hospital independently of study enrolment.

No randomization or placebo will be used. ECG measurements will be compared to existing data from a healthy population.

Measurements

  • ECG: PR-interval, p-wave area, PTFV1
  • wavECG: LVDD
  • Heart rhythm monitoring: AF

Statistical considerations Consecutive patients attending the Department of Abdominal Surgery at Bispebjerg-Frederiksberg Hospital will be invited to participate in the pre- and post-operative examination programme. The study aim is to identify the true incidence of peri- and postoperative AF. Hence, sample size calculations are uncertain. The expected incidence of AF for non-oesophageal surgery patients is at least 7.63%.10 Pre-operative p-wave indices have shown ability to predict POAF in cardiac surgery population of 105 patients (with incidence 11%).21 wavECG has been used to show LVDD in a study population of 188 patients referred for computed tomography angiography of the heart.16 The study will include 300 patients. Follow-up will be at least 12 months. Parametric statistics is used as normal distribution is expected with two-sample unpaired Student's t-test (continuous variables) and Chi-square and Fisher's exact test (categorical variables) where appropriate. Data is presented with mean (±standard deviation) for continuous variables and frequency (percentages) for categorical variables. All tests are two-sided and a P-value < 0.05 is considered statistically significant. Furthermore, non-parametric Kaplan-Meier (time-to-event) curves will be produced and log rank test (chi-square and hazard ratio) will be used for comparison. IBM SPSS version 22 will be used for statistical analyses.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Consecutive adult patients undergoing abdominal surgery at the Department of Abdominal Surgery at Bispebjerg Hospital (Copenhagen, Denmark)
Condition
  • Atrial Fibrillation
  • Surgery--Complications
Intervention Diagnostic Test: Holter monitoring
Cardiac rhythm monitoring before, during and at least 72 hours after abdominal surgery
Study Groups/Cohorts Cohort
Intervention: Diagnostic Test: Holter monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 13, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Acute or elective abdominal surgery (non-oesophageal)

Exclusion Criteria:

  • Pregnancy
  • Follow-up not possible
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Christoffer V Madsen, MD +4538163816 ext 4376 christoffer.valdorff.madsen.01@regionh.dk
Contact: Helena Dominguez, MD, assoc pr +4538163816 ext 6068 maria.helena.dominguez.vall-lamora.02@regionh.dk
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT04090905
Other Study ID Numbers H-19033464
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Christoffer Valdorff Madsen, Frederiksberg University Hospital
Study Sponsor Frederiksberg University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Christoffer V Madsen, MD Bispebjerg Frederiksberg Hospital
PRS Account Frederiksberg University Hospital
Verification Date June 2020