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

Primary Purpose

Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
30-second ECG using the Kardia Mobile
routine care
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Screen group

    Usual Care

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    February 27, 2023
    Last Updated
    March 13, 2023
    Sponsor
    University of Oklahoma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05784766
    Brief Title
    Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial
    Acronym
    SARIC
    Official Title
    Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    July 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Oklahoma

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    480 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Screen group
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Usual Care
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    30-second ECG using the Kardia Mobile
    Intervention Description
    30-second ECG using the Kardia Mobile
    Intervention Type
    Other
    Intervention Name(s)
    routine care
    Intervention Description
    medical review
    Primary Outcome Measure Information:
    Title
    The Investigators will compare the incidence of newly diagnosed AF identified by screening versus usual care
    Description
    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 Outcome Measure Information:
    Title
    To determine the effect of screening-detected AF on initiation of anticoagulation.
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Stout, RN
    Phone
    405271-9060
    Ext
    44761
    Email
    Michael-H-Stout@ouhsc.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zain Asad, MD
    Phone
    405-271-4742
    Email
    ZainUlAbideen.Asad@ouhealth.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zain Asad, MD
    Organizational Affiliation
    OU Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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