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Trial Title:
Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial
NCT ID:
NCT05784766
Condition:
Cancer
Conditions: Official terms:
Atrial Fibrillation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
30-second ECG using the Kardia Mobile
Description:
30-second ECG using the Kardia Mobile
Arm group label:
Screen group
Intervention type:
Other
Intervention name:
routine care
Description:
medical review
Arm group label:
Usual Care
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
65 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Aurora Vera
Phone:
405-271-9060
Phone ext:
45319
Contact backup:
Last name:
Natalia Serrano
Phone:
405-271-9060
Phone ext:
37520
Start date:
November 6, 2023
Completion date:
July 30, 2025
Lead sponsor:
Agency:
University of Oklahoma
Agency class:
Other
Source:
University of Oklahoma
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05784766
