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

University of Oklahoma (OU)

Status: Enrolling

Conditions: Cancer

Treatments: Diagnostic Test: 30-second ECG using the Kardia Mobile; Other: routine care

Study type: Interventional

Funder types: Other

Identifiers

NCT05784766

15595

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

Screen group

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: 30-second ECG using the Kardia Mobile

Usual Care

Active Comparator group

Description:

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.

Treatment:

Other: routine care