Cardiac DiseaseSCANNCT06891222
A Study of Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening
An observational study of Cardiac Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate and compare the effectiveness of active screening for SHD in asymptomatic outpatients referred for an ECG, using a combination of AI-ECG and FOCUS. Invites will be sent and participants enrolled electronically. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- AI-ECG (artificial intelligence-enabled electrocardiogram) and Focus Screening (focused cardiac ultrasonography)
- How many people
- 2,705 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2025to Dec 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subjects aged 18 or older without known congenital or acquired SHD scheduled to undergo an elective outpatient electrocardiogram
Who may be able to join
- Adult patients (>18 years of age)
- Echocardiogram is not clinically indicated
Who cannot join
- Prior history of congenital or acquired SHD, as defined by the following
- Aortic Stenosis:
- Heart Failure
- Left Ventricular Dysfunction
- Cardiac Amyloidosis
- Hypertrophic Cardiomyopathy (HCM)
Show all 11Show fewer
- Rheumatic Heart Disease
- Congenital Heart Disease
- Recent (within last 12 months) echocardiogram
- Scheduled clinically indicated future echocardiogram
- Inability to provide informed consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening; Structural Cardiac Assessment With Networked AI-ECG & FOCUS (SCAN) Study
The purpose of this study is to evaluate and compare the effectiveness of active screening for SHD in asymptomatic outpatients referred for an ECG, using a combination of AI-ECG and FOCUS. Invites will be sent and participants enrolled electronically.
- Conditions
- Cardiac Disease
- Being tested
- AI-ECG (artificial intelligence-enabled electrocardiogram), Focus Screening (focused cardiac ultrasonography)
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-ECG (artificial intelligence-enabled electrocardiogram)Diagnostic test
Participants will undergo electrocardiogram analysis using AI-ECG during the baseline visit
Focus Screening (focused cardiac ultrasonography)Diagnostic test
Participants will undergo a focused cardiac ultrasound if the AI-ECG reflects a positive value
| Study group | Role | What they receive |
|---|---|---|
| Integrated pathway | Not described Receives: Diagnostic Test: AI-ECG (artificial intelligence-enabled electrocardiogram); Diagnostic Test: Focus Screening (focused cardiac ultrasonography) | |
| Standard of Care pathway | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects to be diagnosed with SHD (structural heart disease)
Percentage of subjects to be diagnosed with SHD will be determined by the number of subjects that have a positive SHD screening. Positive SHD screening is defined by any one of the following: decreased LVEF (left ventricular ejection fraction), cardiac amyloidosis, aortic stenosis, and hypertrophic cardiomyopathy.
Measured: Baseline, 6 months, 1 year
Positive predictive value (PPV)
Positive predictive value (PPV) will be measured as a percentage. PPV will reflect the percentage of times that each screening pathway matches a formal echocardiogram diagnosis.
Measured: Baseline, 6 months, 1 year
Secondary outcomes (6)
Number of deaths
Number of deaths will include all-cause deaths.
Measured: 1 year
Number of adverse cardiovascular events
Number of adverse cardiovascular events includes systolic heart failure, rt failure hospitalization.
Measured: 1 year
Percentage of subjects to be diagnosed with decreased LVEF (left ventricular ejection fraction)
Percentage of subjects to be diagnosed with decreased LVEF will be determined by the percentage of subjects to have a LVEF lower than 50%.
Measured: Baseline, 6 months,1 year
Percentage of subjects to be diagnosed with cardiac amyloidosis
Percentage of subjects to be diagnosed with cardiac amyloidosis will be determined by the number of subjects that have a positive AI-ECG or ultrasound. Cardiac amyloidosis is the buildup of protein in the heart muscle that affect the structure and function of the heart.
Measured: Baseline, 6 months,1 year
Percentage of subjects to be diagnosed with aortic stenosis
Percentage of subjects to be diagnosed with aortic stenosis will be determined by the number of subjects that have a positive AI-ECG or ultrasound. Aortic stenosis is the narrowing of the aortic value decreasing the blood flow from heart to the aorta.
Measured: Baseline, 6 months,1 year
Percentage of subjects to be diagnosed with hypertrophic cardiomyopathy
Percentage of subjects to be diagnosed with hypertrophic cardiomyopathy will be determined by the number of subjects that have a positive AI-ECG or ultrasound. Hypertrophic cardiomyopathy is the thickening of the heart muscle which leads to reduced blood flow.
Measured: Baseline, 6 months,1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start14 Apr 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gal Tsaban, Mayo Clinic
- Investigators
- Gal Tsaban, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891222
- Sponsor's protocol ID
- 25-000609
- Acronym
- SCAN
- Status last verified
- May 2026
- First submitted
- 18 Mar 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening; Structural Cardiac Assessment With Networked AI-ECG & FOCUS (SCAN) Study
- ClinicalTrials.gov ID
- NCT06891222
- Acronym / sponsor ID
- SCAN / 25-000609
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,705 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Mar 2025 (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.
The purpose of this study is to evaluate and compare the effectiveness of active screening for SHD in asymptomatic outpatients referred for an ECG, using a combination of AI-ECG and FOCUS. Invites will be sent and participants enrolled electronically.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated pathway | – | Diagnostic Test: AI-ECG (artificial intelligence-enabled electrocardiogram), Diagnostic Test: Focus Screening (focused cardiac ultrasonography) |
| Standard of Care pathway | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects aged 18 or older without known congenital or acquired SHD scheduled to undergo an elective outpatient electrocardiogram
Key inclusion criteria (2 listed)
- Adult patients (>18 years of age)
- Echocardiogram is not clinically indicated
Key exclusion criteria (11 listed)
- Prior history of congenital or acquired SHD, as defined by the following
- Recent (within last 12 months) echocardiogram
- Scheduled clinically indicated future echocardiogram
- Inability to provide informed consent to participate in the study
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 |
|---|---|---|
| AI-ECG (artificial intelligence-enabled electrocardiogram)Participants will undergo electrocardiogram analysis using AI-ECG during the baseline visit | Diagnostic test | Integrated pathway |
| Focus Screening (focused cardiac ultrasonography)Participants will undergo a focused cardiac ultrasound if the AI-ECG reflects a positive value | Diagnostic test | Integrated pathway |
Primary outcome
Percentage of subjects to be diagnosed with SHD (structural heart disease)
Time frame: Baseline, 6 months, 1 year
Percentage of subjects to be diagnosed with SHD will be determined by the number of subjects that have a positive SHD screening. Positive SHD screening is defined by any one of the following: decreased LVEF (left ventricular ejection fraction), cardiac amyloidosis, aortic stenosis, and hypertrophic cardiomyopathy.
Positive predictive value (PPV)
Time frame: Baseline, 6 months, 1 year
Positive predictive value (PPV) will be measured as a percentage. PPV will reflect the percentage of times that each screening pathway matches a formal echocardiogram diagnosis.
6 secondary outcomes
Number of deaths
Time frame: 1 year
Number of adverse cardiovascular events
Time frame: 1 year
Percentage of subjects to be diagnosed with decreased LVEF (left ventricular ejection fraction)
Time frame: Baseline, 6 months,1 year
Percentage of subjects to be diagnosed with cardiac amyloidosis
Time frame: Baseline, 6 months,1 year
Percentage of subjects to be diagnosed with aortic stenosis
Time frame: Baseline, 6 months,1 year
Percentage of subjects to be diagnosed with hypertrophic cardiomyopathy
Time frame: Baseline, 6 months,1 year
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 8 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Gal Tsaban, M.D., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by Mayo Clinic 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 2 inclusion and 11 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 8 Jun 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?
Percentage of subjects to be diagnosed with SHD (structural heart disease) (time frame: Baseline, 6 months, 1 year). The study lists 2 primary outcomes in all. 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 8 Jun 2026.