CancerSARICNCT05784766
Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial
A study testing 30-second ECG using the Kardia Mobile and routine care in people with Cancer, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Cancer
- What is being tested?
- 30-second ECG using the Kardia Mobile and routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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. .
Who cannot join
- Known history of atrial fibrillation.
- Non-English-speaking participants will not be enrolled
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- 30-second ECG using the Kardia Mobile, routine care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30-second ECG using the Kardia MobileDiagnostic test
30-second ECG using the Kardia Mobile
routine careOther
medical review
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 MONTHS
Secondary outcomes (1)
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.
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start6 Nov 2023
- Primary completion13 Jun 2025
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zain Asad, MD, Principal investigator, OU Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784766
- Sponsor's protocol ID
- 15595P
- Acronym
- SARIC
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05784766
- Acronym / sponsor ID
- SARIC / 15595P
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 494 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screen group | Active comparator | Diagnostic Test: 30-second ECG using the Kardia MobilePatients 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. |
| Usual Care | Active comparator | Other: routine careFor 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. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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. .
Key exclusion criteria (2 listed)
- Known history of atrial fibrillation.
- Non-English-speaking participants will not be enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30-second ECG using the Kardia Mobile30-second ECG using the Kardia Mobile | Diagnostic test | Screen group |
| routine caremedical review | Other | Usual Care |
Primary outcome
The Investigators will compare the incidence of newly diagnosed AF identified by screening versus usual care
Time frame: 6 MONTHS
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.
1 secondary outcome
To determine the effect of screening-detected AF on initiation of anticoagulation.
Time frame: 6 MONTHS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zain Asad, MD principal investigator
OU Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30-second ECG using the Kardia Mobile and routine care in people with Cancer, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Investigators will compare the incidence of newly diagnosed AF identified by screening versus usual care (time frame: 6 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.