DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery (DETECT-POAF)

November 5, 2024 updated by: Population Health Research Institute

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Recruiting
        • Hamilton General Hospital
        • Contact:
          • Research Coordinator
          • Phone Number: 44156 905-521-2100
          • Email: gregus@hhsc.ca
        • Contact:
          • Mohamed Panju, MD
      • Hamilton, Ontario, Canada, L8V 1C3
        • Recruiting
        • Juravinski Hospital
        • Contact:
          • Ameen Patel, MD
      • Hamilton, Ontario, Canada, L8N 4A6
        • Not yet recruiting
        • St. Joseph's Healthcare Hamilton
        • Contact:
          • Vikas Tandon, MD
      • London, Ontario, Canada, N6A 5A5
        • Not yet recruiting
        • London Health Sciences Centre - University Hospital
        • Contact:
          • Marko Mrkobrada, MD
      • St. Catharines, Ontario, Canada, L2S 0A9
        • Not yet recruiting
        • Niagara Health System - St. Catharine's Site
        • Contact:
          • Leonard Blair, MD
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5H3
        • Not yet recruiting
        • Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke
        • Contact:
          • Felix Ayala-Paredes, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults who have undergone noncardiac surgery

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Study Cohort
Participants will receive up to 14 days of continuous cardiac monitoring
Device: Cardiac monitoring device
Portable, up to 14 days of monitoring

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within 35 days of non-cardiac surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of sustained ventricular arrhythmia
Time Frame: Within 35 days of non-cardiac surgery
Within 35 days of non-cardiac surgery
Incidence of sinus node dysfunction
Time Frame: Within 35 days of non-cardiac surgery
Within 35 days of non-cardiac surgery
Incidence of high-grade atrioventricular block
Time Frame: Within 35 days of non-cardiac surgery
Within 35 days of non-cardiac surgery
Incidence of death
Time Frame: Within 35 days of non-cardiac surgery
Within 35 days of non-cardiac surgery
Incidence of clinically important post-operative atrial fibrillation/atrial flutter
Time Frame: Within 14 days of continuous cardiac monitoring
Within 14 days of continuous cardiac monitoring
Incidence of clinically important post-operative atrial fibrillation/atrial flutter detected by clinical monitoring only
Time Frame: Within 35 days of non-cardiac surgery
Within 35 days of non-cardiac surgery
Incidence of clinically important post-operative atrial fibrillation/atrial flutter define with minimum duration of 6 minutes
Time Frame: Within 35 days of non-cardiac surgery
Within 35 days of non-cardiac surgery
Incidence of clinically important post-operative atrial fibrillation/atrial flutter detected by study device monitoring only
Time Frame: Within 35 days of non-cardiac surgery
Within 35 days of non-cardiac surgery
Proportion of participants meeting eligibility criteria for ASPIRE-AF study
Time Frame: Within 35 days of non-cardiac surgery
Within 35 days of non-cardiac surgery
Multivariate odds ratio of risk factors associated with the occurrence of clinically important POAF
Time Frame: Within 35 days of non-cardiac surgery
A multivariate logistic regression analysis of age, sex, surgical urgency, type of surgery, vascular disease, chronic kidney disease, and heart failure.
Within 35 days of non-cardiac surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Population Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Conen, MD, MPH, Population Health Research Institute
  • Principal Investigator: Michael K Wang, MD, Population Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-DETECTPOAF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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