CClinicalTrials.gg
Active, not recruitingNCT05784766SARICUpdated Apr 6, 2026

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

An interventional study of 30-second ECG using the Kardia Mobile and routine care in Cancer, sponsored by University of Oklahoma. Active, not recruiting at 1 site in United States. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by University of Oklahoma · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
494
Allocation
Randomized
Ages
65 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer

Browse trials for

03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 494 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Known history of atrial fibrillation.
  2. Non-English-speaking participants will not be enrolled
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
494 participants (actual)

Study arms

  • Active comparator
    Screen group

    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). If the mobile ECG shows possible AF or unclassified, then patients will undergo a 12-lead standard ECG during the same visit, read by a cardiologist, to verify the correct diagnosis.

    Diagnostic Test: 30-second ECG using the Kardia Mobile

  • Active comparator
    Usual Care

    For patients in the usual care arm, medical record review will be done at end of study to assess for the newly diagnosed AF during the study period.

    Other: routine care

Interventions

  • Diagnostic test30-second ECG using the Kardia Mobile

    30-second ECG using the Kardia Mobile

  • Otherroutine care

    medical review

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 MONTHS

Secondary outcomes

  1. 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.

    Time frame: 6 MONTHS

07

Study locations

1 site
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05784766
Lead sponsor
University of Oklahoma
Responsible party
Sponsor
First posted
Mar 27, 2023
Start date
Nov 6, 2023
Primary completion
Jun 13, 2025
Completion
Jan 2027 (estimated)
Last update
Apr 6, 2026

Study contacts

Zain Asad, MD
principal investigator · OU Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion