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

NCT04090918 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2021-10-27

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Cardiac examination programme 3 months after abdominal surgery

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

Sponsors & Collaborators

  • Frederiksberg University Hospital

    lead OTHER

Principal Investigators

  • Christoffer V Madsen, MD · University Hospital Bispebjerg and Frederiksberg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2021-10-19
Completion
2021-10-19

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04090918 on ClinicalTrials.gov