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

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ClinicalTrials.gov Identifier: NCT04090918
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Christoffer Valdorff Madsen, Frederiksberg University Hospital

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.


Condition or disease Intervention/treatment
Atrial Fibrillation Surgery--Complications Diagnostic Test: Cardiac examination programme 3 months after abdominal surgery

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Novel Methods for Characterizing Patients With Post-operative Atrial Fibrillation Secondary to Abdominal Surgery (A SECAFIB-SURG Sub-study)
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Blood- and urine sampling, electrocardiogram, wavECG (Myovista), transthoracic echocardiography, Finapres, cardiac magnetic resonance imaging

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




Primary Outcome Measures :
  1. Number of patients with abnormal left atrial strain [ Time Frame: Three months after abdominal surgery ]
    Left atrial strain abnormality as measured by transthoracic echocardiography


Secondary Outcome Measures :
  1. Number of patients with clinical events after surgery [ Time Frame: From surgery until 1 year after surgery ]
    Clinical events defined as: reoperation; occurrence/recurrence of AF; ischemic stroke or transient ischemic attack; all-cause mortality


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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090918


Contacts
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Contact: Christoffer V Madsen, MD +4520661178 cmad0140@regionh.dk
Contact: Helena Dominguez, MD, assoc pr +4522989343 mdom0002@regionh.dk

Locations
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Denmark
Bispebjerg-Frederiksberg Hospital Not yet recruiting
Copenhagen, Denmark
Contact: Christoffer V Madsen, MD    +4520661178    cmad0140@regionh.dk   
Sponsors and Collaborators
Frederiksberg University Hospital
Investigators
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Principal Investigator: Christoffer V Madsen, MD Bispebjerg-Frederiksberg Hospital

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Responsible Party: Christoffer Valdorff Madsen, Principal Investigator, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT04090918     History of Changes
Other Study ID Numbers: H-19033687
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will be shared after study completion upon researchers reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christoffer Valdorff Madsen, Frederiksberg University Hospital:
post-operative atrial fibrillation
abdominal surgery
left atrial strain
atrial remodelling
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes