Monitoring heart rhythm after noncardiac surgery

Enhanced DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery with Continuous Electrocardiographic Monitoring

This study is testing if wearing a portable heart monitor for up to 14 days after noncardiac surgery can help find heart rhythm problems that are often missed, to improve care for patients.

Quick facts

• Study type: Observational
• Enrollment: 750 (estimated)
• Ages: 18 Years to 120 Years
• Sex: All
• Sponsor: Population Health Research Institute (Academic / other)
• Locations: 6 sites (Hamilton, Ontario and 5 other locations)
• Trial ID: NCT06519747 on ClinicalTrials.gov

What this trial studies

This multicenter prospective cohort study aims to detect perioperative atrial fibrillation (POAF) by utilizing continuous ECG monitoring for up to 14 days in patients who have undergone noncardiac surgery. Patients will wear a portable monitoring device starting within 72 hours post-surgery to identify the incidence of clinically significant POAF. The study seeks to address the common oversight of POAF in clinical practice, which can lead to adverse long-term outcomes. By enhancing detection through continuous monitoring, the study aims to improve clinical care for affected patients.

Who should consider this trial

Good fit: Ideal candidates are patients aged 55 years and older who have undergone noncardiac surgery within the past 72 hours and meet specific high-risk criteria.

Not a fit: Patients who have undergone low-risk surgeries or those who do not meet the age and health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better detection and management of atrial fibrillation in patients after noncardiac surgery, potentially improving long-term outcomes.

How similar studies have performed: Other studies have shown success in using continuous ECG monitoring for detecting atrial fibrillation, indicating that this approach is promising.

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.

Where this trial is running

Hamilton, Ontario and 5 other locations

• Hamilton General Hospital — Hamilton, Ontario, Canada (Recruiting)
• St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (Not_yet_recruiting)
• Juravinski Hospital — Hamilton, Ontario, Canada (Recruiting)
• London Health Sciences Centre - University Hospital — London, Ontario, Canada (Not_yet_recruiting)
• Niagara Health System - St. Catharine's Site — St. Catharines, Ontario, Canada (Not_yet_recruiting)
• Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke — Sherbrooke, Quebec, Canada (Not_yet_recruiting)

Study contacts

• Principal investigator: David Conen, MD, MPH — Population Health Research Institute
• Study coordinator: Vitheya Thanabalan

Conditions Atrial Fibrillation; Atrial Flutter; Cardiac monitoring