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

NCT04090918 | Withdrawn

• 1 other identifier: H-19033687
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation; Surgery--Complications

Keywords

post-operative atrial fibrillation; abdominal surgery; left atrial strain; atrial remodelling

Outcome Measures

Primary Outcomes (1)

• Number of patients with abnormal left atrial strain

  Left atrial strain abnormality as measured by transthoracic echocardiography

  Three months after abdominal surgery

Secondary Outcomes (1)

• Number of patients with clinical events after surgery

  From surgery until 1 year after surgery

Study Arms (2)

Group 1: Abdominal surgery with POAF

Twenty patients undergoing abdominal surgery with new-onset atrial fibrillation

Diagnostic Test: Cardiac examination programme 3 months after abdominal surgery

Group 2: Abdominal surgery without POAF

Twenty patients undergoing abdominal surgery without new-onset atrial fibrillation matching patients in group 1 on age, sex and comorbidities.

Diagnostic Test: Cardiac examination programme 3 months after abdominal surgery

Interventions

Cardiac examination programme 3 months after abdominal surgery DIAGNOSTIC_TEST

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

Group 1: Abdominal surgery with POAF; Group 2: Abdominal surgery without POAF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Signed informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Frederiksberg University Hospital: lead

Study Sites (1)

Bispebjerg-Frederiksberg Hospital

Copenhagen, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A venous blood sample (approximately 30 mL) and a urine sample (approximately 30 mL) will be collected for a Research biobank. Blood samples will be collected in EDTA- and serum tubes, respectively, extracting plasma (from the EDTA tube) and serum (from the serum tube). Samples are subsequently immediately frozen and transported on dry ice to a -80 degree freezer at Copenhagen University's Faculty of Health and Medical Sciences. Samples will be analysed when the last sample has been collected. Analyses will focus on markers of oxidative stress, coagulation abnormalities (factors II, VII, X and von Willebrand Factor) as well as fibrosis.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christoffer V Madsen, MD

  University Hospital Bispebjerg and Frederiksberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 16, 2019
• Study Start: October 19, 2021
• Primary Completion: October 19, 2021
• Study Completion: October 19, 2021
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)