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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 : 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:

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.


Condition or disease Intervention/treatment
Atrial Fibrillation Surgery--Complications Diagnostic Test: Holter monitoring

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Post-operative Atrial Fibrillation Secondary to Abdominal Surgery - A Single-centre, Prospective, Cohort Study
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cohort Diagnostic Test: Holter monitoring
Cardiac rhythm monitoring before, during and at least 72 hours after abdominal surgery




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Number of patients with abnormal p-wave indexes [ Time Frame: Before surgery ]
    Abnormal p-wave indexes on electrocardiogram

  3. Number of patients with left ventricular diastolic dysfunction [ Time Frame: Before surgery ]
    Left ventricular diastolic dysfunction as measured on wavECG (Myovista)



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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
Consecutive adult patients undergoing abdominal surgery at the Department of Abdominal Surgery at Bispebjerg Hospital (Copenhagen, Denmark)
Criteria

Inclusion Criteria:

  • Acute or elective abdominal surgery (non-oesophageal)

Exclusion Criteria:

  • Pregnancy
  • 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): NCT04090905


Contacts
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Contact: Christoffer V Madsen, MD +4520661178 cmad0140@regionh.dk
Contact: Helena Dominguez, MD, assoc pr +4522989343 mdom0002@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, Primary Investigator, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT04090905     History of Changes
Other Study ID Numbers: H-19033464
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

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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
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes