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

Cancer Clinical Trial

— SARIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05784766
• Other study ID #: 15595
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2023
• Est. completion date: July 30, 2025

Study information

• Verified date: November 2023
• Source: University of Oklahoma
• Contact: Aurora Vera, RMA
• Phone: 405-271-9060
• Email: Aurora-vera[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: July 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cancer

Intervention

Diagnostic Test:
• 30-second ECG using the Kardia Mobile
30-second ECG using the Kardia Mobile

Other:
• routine care
medical review

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Investigators will compare the incidence of newly diagnosed AF identified by screening versus usual care	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.	6 MONTHS
Secondary	To determine the effect of screening-detected AF on initiation of anticoagulation.	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.	6 MONTHS