Clinical trial NCT06519747: DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery
Official title: Enhanced DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery with Continuous Electrocardiographic Monitoring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Atrial Flutter
Keywords: Cardiac monitoring
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who have undergone noncardiac surgery

Brief summary: This is a multicentre prospective cohort study where patients will receive up to 14 days of continuous ECG monitoring by wearing a portable monitoring device, starting within 72 hours after noncardiac surgery.

Detailed description: POAF commonly occurs after noncardiac surgery and is associated with adverse long-term outcomes. Despite this, patients with POAF are routinely being missed during clinical practice. Continuous ECG monitoring has the potential to enhance POAF detection and improve clinical care in affected patients. Based on this background, the DETECT-POAF study will determine the incidence of clinically important POAF in those receiving up to 14 days of continuous ECG monitoring within 35 days after noncardiac surgery.

Eligibility criteria: Inclusion Criteria:

1. Had undergone noncardiac surgery within the past 72 hours and requiring, or expected to require, at least one of the following:

   * an overnight hospital admission after surgery
   * day surgery that would result in a large enough physiological insult to be able to cause POAF. Procedures excluded include those that are conducted using local anesthesia alone, are less than 30 minutes in duration, and/or are judged to be of low physiologic insult by the local investigator.
2. Have one of the following high-risk criteria;

   * age 55-64 years, and having either established cardiovascular disease, recent major vascular surgery, a CHA2DS2-VASc score ≥3, or an elevated postoperative troponin level;
   * age 65-74 years, and having either established cardiovascular disease, recent major vascular surgery, a CHA2DS2-VASc score ≥2, or an elevated postoperative troponin level; or
   * age ≥75 years;
3. Provide written informed consent to participate.

Exclusion Criteria:

1. History of documented chronic (i.e., non-transient) AF before noncardiac surgery;
2. Need for long-term systemic anticoagulation;
3. Ongoing need for long-term dual antiplatelet treatment;
4. Contraindication to oral anticoagulation;
5. Severe renal insufficiency;
6. Severe liver cirrhosis;
7. Acute stroke in the past 14 days;
8. Underwent cardiac surgery in the past 35 days;
9. History of nontraumatic intracranial, intraocular, or spinal bleeding;
10. Hemorrhagic disorder or bleeding diathesis;
11. Known life expectancy \<1 year due to concomitant disease;
12. Women who are pregnant, breastfeeding, or of childbearing potential not taking effective contraception;
13. Expected to be non-compliant with follow-up and/or device use;
14. Known contact allergy to monitoring device and/or its peripheral components;
15. Previously enrolled in DETECT-POAF.

Primary outcomes:
measure: Incidence of clinically important post-operative atrial fibrillation/atrial flutter
timeFrame: Within 35 days of non-cardiac surgery
Secondary outcomes:
measure: Incidence of sustained ventricular arrhythmia
timeFrame: Within 35 days of non-cardiac surgery
measure: Incidence of sinus node dysfunction
timeFrame: Within 35 days of non-cardiac surgery
measure: Incidence of high-grade atrioventricular block
timeFrame: Within 35 days of non-cardiac surgery
measure: Incidence of death
timeFrame: Within 35 days of non-cardiac surgery
measure: Incidence of clinically important post-operative atrial fibrillation/atrial flutter
timeFrame: Within 14 days of continuous cardiac monitoring
measure: Incidence of clinically important post-operative atrial fibrillation/atrial flutter detected by clinical monitoring only
timeFrame: Within 35 days of non-cardiac surgery
measure: Incidence of clinically important post-operative atrial fibrillation/atrial flutter define with minimum duration of 6 minutes
timeFrame: Within 35 days of non-cardiac surgery
measure: Incidence of clinically important post-operative atrial fibrillation/atrial flutter detected by study device monitoring only
timeFrame: Within 35 days of non-cardiac surgery
measure: Proportion of participants meeting eligibility criteria for ASPIRE-AF study
timeFrame: Within 35 days of non-cardiac surgery
measure: Multivariate odds ratio of risk factors associated with the occurrence of clinically important POAF
timeFrame: Within 35 days of non-cardiac surgery
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Health System - St. Catharine's Site
state: Ontario
city: Sherbrooke
country: Canada
facility: Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Population Health Research Institute
name: David Conen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute
name: Michael K Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: