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

NCT05784766 | Unknown DMC FDA Device

• 1 other identifier: 15595
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

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.

  6 MONTHS

Secondary Outcomes (1)

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

  6 MONTHS

Study Arms (2)

Screen group

ACTIVE COMPARATOR

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

Usual Care

ACTIVE COMPARATOR

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

30-second ECG using the Kardia Mobile DIAGNOSTIC_TEST

30-second ECG using the Kardia Mobile

Screen group

routine care OTHER

medical review

Usual Care

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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. .

You may not qualify if:

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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Zain Asad, MD

  OU Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurora Vera, RMA

CONTACT

405-271-9060; Aurora-vera@ouhsc.edu

Zain Asad, MD

CONTACT

405-271-4742; ZainUlAbideen.Asad@ouhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 27, 2023
• Study Start: November 6, 2023
• Primary Completion: December 31, 2024
• Study Completion: July 30, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

US (1)