Incidence of Post-operative Atrial Fibrillation Secondary to Abdominal Surgery (SECAFIB-SURG)
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|ClinicalTrials.gov Identifier: NCT04090905|
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : June 30, 2020
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|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Incidence of Post-operative Atrial Fibrillation Secondary to Abdominal Surgery - A Single-centre, Prospective, Cohort Study|
|Actual Study Start Date :||June 13, 2020|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Diagnostic Test: Holter monitoring
Cardiac rhythm monitoring before, during and at least 72 hours after abdominal surgery
- 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
- 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
- Number of patients with abnormal p-wave indexes [ Time Frame: Before surgery ]Abnormal p-wave indexes on electrocardiogram
- Number of patients with left ventricular diastolic dysfunction [ Time Frame: Before surgery ]Left ventricular diastolic dysfunction as measured on wavECG (Myovista)
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
|Contact: Christoffer V Madsen, MD||+4538163816 ext firstname.lastname@example.org|
|Contact: Helena Dominguez, MD, assoc pr||+4538163816 ext email@example.com|
|Contact: Christoffer V Madsen, MD +4538163816 ext 4376 firstname.lastname@example.org|
|Principal Investigator:||Christoffer V Madsen, MD||Bispebjerg Frederiksberg Hospital|