Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial

Not Applicable

Recruiting

• Conditions: Cancer

• Registration Number: NCT05784766
• Lead Sponsor: University of Oklahoma

Brief Summary

Patients with cancer have a higher incidence of AF but despite the higher incidence of AF in the cancer population, there are no randomized controlled trials (RCTs) for AF screening in this population. RCTs of AF screening in the general population have shown that screening can effectively detect AF earlier, and helps to identify candidates for appropriate anticoagulation that may lead to improvement in clinical outcomes.

Detailed Description

The Investigators will conduct an open label, prospective, pilot RCT. After informed consent, patients will be randomized 1:1 into screening or usual care. Screening will be done at a single time point. Patients randomized to screening will undergo a 30-second ECG using the Kardia Mobile device (AliveCor Inc, Cupertino, CA) paired with an iPad (Apple, Cupertino, CA). Patients randomized to usual care will not receive a screening ECG. Primary outcome will be detection of newly diagnosed AF by screening vs usual care.

Study Timeline

• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-27
• Status Verified: 2023-11
• Study Start: 2023-11-06
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

1. Male and female patients age ≥65 with a current diagnosis or history of cancer.
2. Patients currently undergoing or history of chemotherapy, radiotherapy or cancer related surgeries will be included.
3. The age is restricted to ≥65 years because prevalence of AF is extremely low. .

Exclusion Criteria

1. Known history of atrial fibrillation.
2. Non-English-speaking participants will not be enrolled

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Investigators will compare the incidence of newly diagnosed AF identified by screening versus usual care	6 MONTHS	To compare the incidence of newly diagnosed AF with point-of-care screening using a mobile, single-lead ECG versus usual care, in patients with a diagnosis of solid cancer. In this open-label, prospective pilot RCT, patients (n=480) with AF and solid cancer presenting for an outpatient visit will be randomized 1:1 to screening versus usual care. A 30-second screening ECG will be done using the Kardia Mobile device (AliveCor Inc, Cupertino, CA) paired with an iPad. The Investigators will compare the incidence of newly diagnosed AF identified by screening versus usual care.

Secondary Outcome Measures

Name	Time	Method
To determine the effect of screening-detected AF on initiation of anticoagulation.	6 MONTHS	To determine the effect of screening-detected AF on initiation of anticoagulation. Patients diagnosed with AF through screening will be referred to their primary care physician for initiation of anticoagulation based on their CHA2DS2VASc score.The Investigators will conduct chart review at the end of study to compare the proportion of patients appropriately initiated on anticoagulation between screening versus usual care.

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States