Atrial Fibrillation Screening for Cancer Patients

(SARIC Trial)

Overseen By Aurora Vera, RMA

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Atrial fibrillation, Non-English-speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if early screening for atrial fibrillation (AF), a heart rhythm disorder, benefits cancer patients. Participants will use a device called Kardia Mobile for a quick, 30-second ECG (electrocardiogram) heart check. If the device detects possible AF, a more detailed heart test will confirm the results. The trial compares this screening method with usual care to assess whether early detection improves health outcomes. Cancer patients aged 65 or older who have undergone treatments like chemotherapy or surgeries may be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance early detection and improve health outcomes for cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Kardia Mobile ECG is safe for cancer patients?

Research has shown that the Kardia Mobile device is safe for taking a quick, 30-second heart rhythm test called an ECG. The FDA has approved this device, confirming it has passed safety checks for everyday use. Users can easily check their heart rhythm without wires or patches. No major safety issues have been reported with its use.

Studies have found that people using Kardia Mobile were much better at detecting atrial fibrillation (AFib), a common heart rhythm issue, without experiencing serious side effects. However, this device is not recommended for individuals with pacemakers or ICDs, which are devices implanted to help control heart rhythms. Overall, most people find the Kardia Mobile easy and safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a quick and convenient method to screen for atrial fibrillation (AF) in cancer patients using the Kardia Mobile device. Unlike traditional methods that typically require a longer 12-lead ECG read by a specialist, this approach offers a 30-second ECG using a mobile device paired with an iPad, making it potentially faster and more accessible. If the initial screening suggests AF, a follow-up with the standard ECG ensures accuracy. This could lead to earlier detection and treatment of AF in cancer patients, who might otherwise go undiagnosed.

What evidence suggests that the Kardia Mobile ECG is effective for detecting atrial fibrillation in cancer patients?

Research shows that the Kardia Mobile device, used by participants in the screening group of this trial, effectively detects atrial fibrillation (AF), a common irregular heartbeat. Studies have demonstrated that this device can identify AF in just 30 seconds, providing quick results similar to those from traditional ECG machines. The FDA has approved the Kardia Mobile, which can also detect other heart rhythm issues like slow heart rate (bradycardia) and fast heart rate (tachycardia). It uses AI technology to help predict possible AF events, making it a valuable tool for early detection. This could be especially helpful for cancer patients, who are at a higher risk of developing AF. ^{4 6 7 8 9}

Who Is on the Research Team?

Zain Asad, MD

Principal Investigator

OU Health

Are You a Good Fit for This Trial?

This trial is for men and women aged 65 or older who have been diagnosed with cancer, including those currently undergoing or with a history of chemotherapy, radiotherapy, or cancer-related surgeries. It's focused on detecting atrial fibrillation (AF), which is more common in the cancer population.

Inclusion Criteria

I have had or am currently having cancer treatment, including surgery.

I am 65 or older with a current or past cancer diagnosis.

I am 65 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Screening for Atrial Fibrillation

Participants undergo a 30-second ECG using the Kardia Mobile device. If AF is suspected, a 12-lead ECG is performed during the same visit.

Single time point

1 visit (in-person)

Follow-up

Participants are monitored for the detection of newly diagnosed AF and initiation of anticoagulation therapy.

6 months

Medical record review at end of study

What Are the Treatments Tested in This Trial?

Interventions

• 30-second ECG using the Kardia Mobile

Trial Overview The study tests if a quick, 30-second ECG using Kardia Mobile can spot AF better than routine care in older adults with cancer. This randomized controlled trial aims to find out whether early detection leads to improved treatment outcomes.

How Is the Trial Designed?

Group I: Screen group Active Control 1 Intervention

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.

Group II: Usual Care Active Control 1 Intervention

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.

30-second ECG using the Kardia Mobile is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Kardia Mobile for:

• Detection of atrial fibrillation and normal sinus rhythm in adults

Approved in European Union as Kardia Mobile for:

• Detection of atrial fibrillation and normal sinus rhythm in adults

Approved in Canada as Kardia Mobile for:

• Detection of atrial fibrillation and normal sinus rhythm in adults

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Published Research Related to This Trial

A survey of 36 European centers revealed that 89% manage cardio-oncologic patients, with 1-5% of cardiovascular patients affected by cancer treatments, highlighting the significant intersection of cardiology and oncology.

While there is a consensus on using echocardiography for screening cardiotoxicity in these patients, practices for risk assessment and safety measures during radiotherapy for those with cardiac implantable electronic devices (CIEDs) vary widely, indicating a need for standardized protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approach to cardio-oncologic patients with special focus on patients with cardiac implantable electronic devices planned for radiotherapy: results of the European Heart Rhythm Association survey. Lenarczyk, R., Potpara, TS., Haugaa, KH., et al.[2018]

Atrial fibrillation is increasingly common among cancer patients, with studies showing a higher incidence and worse outcomes, indicating a significant connection between the two conditions.

There is a bidirectional relationship between cancer and atrial fibrillation, influenced by shared risk factors and potentially common biological mechanisms, highlighting the need for tailored management strategies for atrial fibrillation in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atrial Fibrillation and Cancer Patients: Mechanisms and Management. Madnick, DL., Fradley, MG.[2022]

Atrial fibrillation is a significant concern in cardio-oncology, influenced by specific cancer types and anticancer medications, which can complicate treatment.

The use of direct oral anticoagulants is increasing, but they must be tailored to each patient to avoid harmful interactions with cancer therapies and manage bleeding risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Anticoagulation in Cancer Patients with Atrial Fibrillation. Szmit, S., Kępski, J., Wilk, M.[2022]

In a study of 6754 oncology patients, the first diagnosis of atrial fibrillation (AF) was more common at or shortly after cancer diagnosis, particularly in older patients and those receiving cardiotoxic treatments, indicating a significant link between cancer and AF onset.

The timing of AF diagnosis impacts mortality; AF diagnosed within 3 years of cancer diagnosis is associated with a higher risk of death, while the CHA2DS2-VASc score, which assesses stroke risk, only correlates with mortality in patients diagnosed with AF later than 3 years after their cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of timing of atrial fibrillation, CHA2DS2-VASc score and cancer therapeutics on mortality in oncology patients. Hussain, M., Misbah, R., Donnellan, E., et al.[2023]

A systematic review of 191 clinical trials involving 26,604 patients revealed that atrial fibrillation (AF) is a notable side effect of certain anticancer drugs, with incidence rates ranging from 0.26 to 4.92 per 100 person-years.

The highest rates of AF were associated with the drugs ibrutinib (4.92 per 100 person-years), clofarabine (2.38), and ponatinib (2.35), suggesting a need for standardized AF monitoring in trials involving these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atrial Fibrillation Incidence Associated With Exposure to Anticancer Drugs Used as Monotherapy in Clinical Trials. Alexandre, J., Boismoreau, L., Morice, PM., et al.[2023]

In a study of 16,056 patients with atrial fibrillation (AF), including 1,137 with cancer, the CHA2DS2-VASc score was found to be poor at predicting embolic risk in cancer patients not treated with anticoagulation, indicating limitations in its use for this population.

The HAS-BLED score also showed poor calibration and discrimination in cancer patients, and a CHA2DS2-VASc score of 0 effectively identified those at low risk for embolic events, suggesting it may be useful for risk stratification in this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of Embolic and Bleeding Risk Scores in Patients With Atrial Fibrillation and Cancer. Raposeiras-Roubin, S., Abu-Assi, E., Marchán, A., et al.[2022]

In a study of 760,339 cancer patients, the HATCH score was found to have the best predictive performance for new-onset atrial fibrillation (AF) compared to the CHA2DS2-VASc and CHADS2 scores, indicating its potential utility in clinical settings.

The predictive accuracy of the scores was assessed using ROC curves, with the HATCH score achieving a c-statistic of 0.69, suggesting it is a reliable tool for identifying patients at risk for AF in the context of newly diagnosed cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of CHA2DS2-VASc, CHADS2 and HATCH scores for the prediction of new-onset atrial fibrillation in cancer patients: A nationwide cohort study of 760,339 study participants with competing risk analysis. Hu, WS., Lin, CL.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10704323/

Diagnostic Accuracy of Single-Lead Electrocardiograms ... This study aimed to examine the agreement between the mobile single-lead ECG measurements of the Kardia Mobile App and the Apple Watch 4

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9971999/

Artificial intelligence–enabled mobile electrocardiograms for ... The purpose of this study was to investigate the utility of AI to predict AF events prospectively and retrospectively using sinus rhythm mECG data.

3. alivecor.com alivecor.com/resource-hub/MTG64%20Non-clinical%20Summary%20Document.pdf

KardiaMobile is now recommended for detecting atrial ... KardiaMobile is a CE-marked, FDA-cleared medical-grade personal ECG device. Our AI-driven technology can detect the most common arrhythmias - AF, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05407415

KardiaMobile ECG Monitoring Effects on Health Care ... Kardia Mobile is an FDA approved device that allows one- or six lead ECG recording for 30 seconds using the patient's smart phone. The device has a automated ...

5. kardia.com kardia.com/products/kardiamobile?srsltid=AfmBOoourFQgek16BRietZ9BdBm70xQ5roQn_9ylQM__G8eDvuQR3_uI

KardiaMobile EKG Monitor - Instant EKG on Your Phone KardiaMobile can detect AFib, Bradycardia, and Tachycardia ... Record a medical-grade EKG in 30 seconds and get an instant analysis right on your phone.

6. kardia.com kardia.com/products/kardiamobile?srsltid=AfmBOorDamY7PE_2y_jzkesqAnT9_mkuzB8VERpzf0_CK0sZdGNqIRZD

KardiaMobile EKG Monitor - Instant EKG on Your Phone Check your heart in 30 seconds with FDA cleared Mobile EKG Monitor. Trusted by top cardiologists. Easy-to-use. No wires, patches or gels. 30-day guarantee.

7. alivecor.com alivecor.com/atrial-fibrillation-kardiamobile

Detect AFib from home with KardiaMobile. Record a medical-grade EKG in just 30 seconds and get instant results. ... KardiaMobile is not tested or recommended for use with pacemakers and ICDs.

8. alivecor.com alivecor.com/press/press_release/new-research-confirms-significance-of-alivecors-30-second-ekg

New Research Confirms Significance of AliveCor's 30 ... Patients using Kardia Mobile had a 4X increase in AFib Detection ... He found that at each 30-second EKG using Kardia Mobile, his team ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0828282X19302260

Clinical Research Screening for Atrial Fibrillation Using a ... Physicians were asked to obtain a single 30-second ECG recording of all patients seen in their daily practice who were ≥65 years old and not previously ...