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

480 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

Is the Kardia Mobile ECG safe for use in humans?

The research articles provided do not contain specific safety data for the Kardia Mobile ECG or its use in humans. ^{1 2 3 4 5}

How is the 30-second ECG using Kardia Mobile unique for atrial fibrillation screening in cancer patients?

The 30-second ECG using Kardia Mobile is unique because it provides a quick, non-invasive way to screen for atrial fibrillation (an irregular heartbeat) in cancer patients, which is different from traditional methods that may require longer monitoring or more complex equipment. This portable device allows for easy and frequent monitoring, which is particularly beneficial for cancer patients who may have increased cardiovascular risks due to their treatment. ^{1 2 3 6 7}

Research Team

Zain Asad, MD

Principal Investigator

OU Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Israel pubmed.ncbi.nlm.nih.gov

Management of Anticoagulation in Cancer Patients with Atrial Fibrillation. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Impact of timing of atrial fibrillation, CHA2DS2-VASc score and cancer therapeutics on mortality in oncology patients. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Atrial Fibrillation Incidence Associated With Exposure to Anticancer Drugs Used as Monotherapy in Clinical Trials. [2023]

4. England 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. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Validation of Embolic and Bleeding Risk Scores in Patients With Atrial Fibrillation and Cancer. [2022]

6. Ireland 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. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Atrial Fibrillation and Cancer Patients: Mechanisms and Management. [2022]