Thinking of joining a study?

Register your interest

NCT05784766 | RECRUITING | Cancer


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

University of Oklahoma

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.

Condition or disease

Cancer

Intervention/treatment

30-second ECG using the Kardia Mobile

routine care

Phase

NA

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
Estimated Enrollment : 480 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial
Actual Study Start Date : 2023-11-06
Estimated Primary Completion Date : 2024-12-31
Estimated Study Completion Date : 2025-07-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 65 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

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

Location Details

NCT05784766


Please Choose a site



How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, Oklahoma

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Loading...