Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04090918 |
| Other study ID # |
H-19033687 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 19, 2021 |
| Est. completion date |
October 19, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Frederiksberg University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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.
