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

November 20, 2023 updated by: University of Oklahoma
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
          • Aurora Vera
          • Phone Number: 45319 405-271-9060
        • Contact:
          • Natalia Serrano
          • Phone Number: 37520 405-271-9060

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
medical review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 MONTHS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Zain Asad, MD, OU Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15595

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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