Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-27 @ 1:34 PM
Study NCT ID:
NCT05784766
Status:
UNKNOWN
Last Update Posted:
2023-11-22
First Post:
2023-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial
Sponsor:
University of Oklahoma
Organization:
Study Overview
Official Title:
Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SARIC
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: