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NCT Number: NCT05784766

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Neoplasms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

30-second ECG using the Kardia Mobile

Diagnostic Test

30-second ECG using the Kardia Mobile

Routine care

Other

medical review

Primary outcomes

  1. The Investigators will compare the incidence of newly diagnosed AF identified by screening versus usual care

    Time frame: 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 outcomes

  1. To determine the effect of screening-detected AF on initiation of anticoagulation.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Acronym: SARIC

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Mar 27, 2023
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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