Enhanced DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery with Continuous Electrocardiographic Monitoring
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Population Health Research Institute
- Enrollment
- 750
- Locations
- 6
- Primary Endpoint
- Incidence of clinically important post-operative atrial fibrillation/atrial flutter
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •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;
- •Provide written informed consent to participate.
Exclusion Criteria
- •History of documented chronic (i.e., non-transient) AF before noncardiac surgery;
- •Need for long-term systemic anticoagulation;
- •Ongoing need for long-term dual antiplatelet treatment;
- •Contraindication to oral anticoagulation;
- •Severe renal insufficiency;
- •Severe liver cirrhosis;
- •Acute stroke in the past 14 days;
- •Underwent cardiac surgery in the past 35 days;
- •History of nontraumatic intracranial, intraocular, or spinal bleeding;
- •Hemorrhagic disorder or bleeding diathesis;
Outcomes
Primary Outcomes
Incidence of clinically important post-operative atrial fibrillation/atrial flutter
Time Frame: Within 35 days of non-cardiac surgery
The primary outcome is clinically important POAF, defined as: 1. Atrial fibrillation (AF) documented by a 12-lead ECG; 2. Confirmed AF (e.g., rhythm strip) that results in symptoms of angina, heart failure, or symptomatic hypotension; 3. Confirmed AF that requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion; or, 4. Confirmed continuous AF episode with a minimum duration of 1 hour.
Secondary Outcomes
- Incidence of death(Within 35 days of non-cardiac surgery)
- Incidence of clinically important post-operative atrial fibrillation/atrial flutter detected by study device monitoring only(Within 35 days of non-cardiac surgery)
- Proportion of participants meeting eligibility criteria for ASPIRE-AF study(Within 35 days of non-cardiac surgery)
- Incidence of sustained ventricular arrhythmia(Within 35 days of non-cardiac surgery)
- Incidence of sinus node dysfunction(Within 35 days of non-cardiac surgery)
- Incidence of high-grade atrioventricular block(Within 35 days of non-cardiac surgery)
- Incidence of clinically important post-operative atrial fibrillation/atrial flutter detected by clinical monitoring only(Within 35 days of non-cardiac surgery)
- Incidence of clinically important post-operative atrial fibrillation/atrial flutter define with minimum duration of 6 minutes(Within 35 days of non-cardiac surgery)
- Incidence of clinically important post-operative atrial fibrillation/atrial flutter(Within 14 days of continuous cardiac monitoring)
- Multivariate odds ratio of risk factors associated with the occurrence of clinically important POAF(Within 35 days of non-cardiac surgery)