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Atrial FibrillationNCT04090918

Novel Methods for Characterizing Patients With Post-operative Atrial Fibrillation Secondary to Abdominal Surgery

An observational study of Atrial Fibrillation and Surgery--Complications, run by Frederiksberg University Hospital at 1 site in Denmark.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Surgery--Complications
What is being tested?
Cardiac examination programme 3 months after abdominal surgery
How many people
0 participants
Where
1 siteDenmark
Study dates
19 Oct 2021to 19 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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 (H-19033464) who have agreed to be contacted if they developed POAF or matched on age and gender with someone who did.

Who may be able to join

  • Signed informed consent

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Bispebjerg-Frederiksberg Hospital

    Copenhagen

Other trials in Denmark

About this study

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

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.

Read more

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.

Read the detailed description

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.

Statistical considerations LA strain analysis has not been performed in this patient group. LA strain has predicted recurrence of AF in patients who have undergone radiofrequency ablation.23,24 In one study, patients with recurrent AF had LA strain mean of 18.4% while those without recurrence had a LA strain mean of 25.5%23. In another study, patients with recurrent AF had LA strain mean of 9.7% while those without recurrence had a LA strain mean of 16.2%.24 With 95% power and alpha 0.05, and enrolment ratio 1:1, 5 patients with - and 5 patients without - are required to identify significant difference in LA strain mean between the two groups. The current population is however expected more heterogenous that those undergoing radiofrequency ablation and as the study is explorative it will include 20 patients with POAF and 20 matched controls without POAF. Follow-up will remain unchanged from the main study, i.e. one year from surgery.

Being tested
Cardiac examination programme 3 months after abdominal surgery
Keywords
post-operative atrial fibrillation, abdominal surgery, left atrial strain, atrial remodelling
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac examination programme 3 months after abdominal surgeryDiagnostic test

    Blood- and urine sampling, electrocardiogram, wavECG (Myovista), transthoracic echocardiography, Finapres, cardiac magnetic resonance imaging

Study groups in NCT04090918
Study groupRoleWhat they receive
Group 1: Abdominal surgery with POAFTwenty patients undergoing abdominal surgery with new-onset atrial fibrillation
Receives: Diagnostic Test: Cardiac examination programme 3 months after abdominal surgery
Group 2: Abdominal surgery without POAFTwenty patients undergoing abdominal surgery without new-onset atrial fibrillation matching patients in group 1 on age, sex and comorbidities.
Receives: Diagnostic Test: Cardiac examination programme 3 months after abdominal surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with abnormal left atrial strain

    Left atrial strain abnormality as measured by transthoracic echocardiography

    Measured: Three months after abdominal surgery

Secondary outcomes (1)
  1. Number of patients with clinical events after surgery

    Clinical events defined as: reoperation; occurrence/recurrence of AF; ischemic stroke or transient ischemic attack; all-cause mortality

    Measured: From surgery until 1 year after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2019
  2. Study start19 Oct 2021
  3. Primary completion19 Oct 2021
  4. Study completion19 Oct 2021

Why it stopped: It was not possible to ensure sufficient recruitment of patients to complete the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04090918
Sponsor's protocol ID
H-19033687
Status last verified
Oct 2021
First submitted
13 Sep 2019
Last updated
27 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No data has been obtained.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Surgery--Complications, run by Frederiksberg University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with abnormal left atrial strain (time frame: Three months after abdominal surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.

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