Coronary Artery DiseaseADVANCE-EDNCT05325112
Assessing Diagnostic Value of Non-invasive FFR-CT in Coronary Care in the Emergency Department
An observational study of Coronary Artery Disease, run by HeartFlow, Inc. at 2 sites in United States.
Trial summary
This is a prospective multi-center study. All clinically stable, symptomatic patients who present to the emergency department (ED) or observation unit with suspected coronary artery disease (CAD) and who have at least one ≥40% lesion and no lesion >90% confirmed by CCTA (Coronary Computed Tomography Angiogram) are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- FFR-CT
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2022to 14 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Clinically stable, symptomatic patients who present to the ED with suspected coronary artery disease and no history of coronary artery disease, and who while in the ED have a CCTA performed which shows at least one ≥40% lesion and no lesions >90% in a major epicardial vessel, and a successfully processed FFR-CT (if applicable).
Who may be able to join
- Age ≥18 years
- Clinically stable, symptomatic patients who present to ED/observation unit with suspected CAD
- CCTA shows at least one ≥40% lesion and no lesions >90% in at least one major epicardial vessel
- FFR-CT processed successfully (if applicable)
- EKG with no acute ischemic changes
- Willing to comply with all aspects of the protocol, including adherence to follow up visit
- Agrees to be included in the study
- Able to provide written informed consent
Who cannot join
- CCTA showing no ≥40% lesion in a major epicardial vessel
- CCTA showing a lesion >90% in a major epicardial vessel
- CCTA showing other incidental, non-cardiac findings requiring admission, e.g., pneumonia, pulmonary embolism, or aortic dissection
- Uninterpretable CCTA which is not of diagnostic quality
- Coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) prior to CCTA acquisition
- Left main lesion >50%
Show all 13Show fewer
- Confirmed acute coronary syndrome (acute myocardial infarction or unstable angina)
- Known complex congenital heart disease or any history of coronary artery disease
- Patients with tachycardia or significant arrhythmia which cannot be adequately controlled with medications to allow CTA
- Any active, serious, life-threatening disease with a life expectancy of less than 2 months
- Inability to comply with follow-up requirements
- Currently enrolled in another study utilizing FFR-CT or in an investigational trial that involves a non-approved cardiac drug or device
- Persons under the protection of justice, guardianship, or curatorship
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Hospital Clevelan
Cleveland, Ohio, 44106
UMass Memorial Hospital
Worcester, Massachusetts, 01605
About this study
Official title: ADVANCE-ED: Assessing Diagnostic Value of Non-invasive FFR-CT in Coronary Care in the Emergency Department
This is a prospective multi-center study. All clinically stable, symptomatic patients who present to the emergency department (ED) or observation unit with suspected coronary artery disease (CAD) and who have at least one ≥40% lesion and no lesion >90% confirmed by CCTA (Coronary Computed Tomography Angiogram) are eligible for enrollment once their CCTA has been completed and their FFR-CT (if applicable) has been ordered. All enrolling sites will have CCTA incorporated into their standard evaluation of chest pain in the ED/observation unit. Non-control sites will have CCTA and FFR-CT analysis incorporated into their standard evaluation of chest pain in the ED/observation unit.
Read the detailed description
This is a prospective multi-center study. All clinically stable, symptomatic patients who present to the ED or observation unit with suspected CAD and who have at least one ≥40% lesion and no lesions <90% lesion in a major vessel, confirmed by CCTA, are eligible for enrollment once their CCTA has been completed and FFR-CT (if applicable) has been ordered. All enrolling sites will have CCTA incorporated into their standard evaluation of chest pain in the ED/observation unit. Non-control sites will have CCTA and FFR-CT analysis incorporated into their standard evaluation of chest pain in the ED/observation unit.
All participating sites will provide demographics, medical history, CCTA images, FFR-CT (for non-control sites), the decision plan post CCTA and pre FFR-CT (for non-control sites), length of stay for patients in the ED/observation unit/hospital, billing reports (UB-04 preferred), 30-day clinical outcomes, and any other hospital or office visits, imaging, and/or procedural data completed prior to the follow-up 30-day visit. Sites which do not have FFR-CT incorporated into the ED/observation unit will be control sites.
- Conditions
- Coronary Artery Disease
- Being tested
- FFR-CT
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFR-CTDiagnostic test
FFR-CT is a diagnostic test following a CCTA to help diagnose and treat coronary artery disease.
| Study group | Role | What they receive |
|---|---|---|
| FFR-CT Group | Sites who have CCTA and FFR-CT analysis incorporated into their standard evaluation of chest pain in the ED/observation unit. Receives: Diagnostic Test: FFR-CT | |
| Control Group | Sites who have CCTA but not FFR-CT incorporated into the ED/observation unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reclassification rate between the coronary management plan based on the review of the CCTA alone compared to the coronary management plan based on the review of the CCTA and the FFR-CT analysis.
For each enrolled patient, investigators used data from coronary CTA,along with the clinical data such as medical history and demographics todetermine the management plan for the patient. The investigator wouldthen also view the patient's FFR-CT results and determine themanagement plan for the patient with the additional information from theFFR-CT. None of the data was collected or analyzed due to the study'searly termination. No additional procedures occurred due to studytermination, and Patients were treated per standard clinical care.
Measured: 30 days
Secondary outcomes (4)
Cost Utility Analysis
Cost measurements to include length of stay in the emergency department and in the hospital overall, secondary coronary artery disease testing, and invasive procedures done.
Measured: 30 days
Rate of Major Adverse Coronary Events (MACE)
Major Adverse Coronary Events (MACE) is defined as the composite ofnonfatal stroke, nonfatal myocardial infarction and cardiovascular death.
Measured: 30 days
Time to primary diagnosis
Time between when the patient first arrives to the emergency department to when the treating physician documents the primary diagnosis.
Measured: Within 30 days
Time to discharge
Time between when the patient first arrives to the emergency department to the time the patient was discharged from the emergency department or the hospital.
Measured: Within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start15 Jul 2022
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Why it stopped: Sponsor decision to terminate the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- HeartFlow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sadeer Al-Kindi, MD, Principal investigator, University Hospitals ClevelandSneha Chinai, MD, Principal investigator, UMass Memorial Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325112
- Sponsor's protocol ID
- CP- 909-001
- Acronym
- ADVANCE-ED
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2022
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADVANCE-ED: Assessing Diagnostic Value of Non-invasive FFR-CT in Coronary Care in the Emergency Department
- ClinicalTrials.gov ID
- NCT05325112
- Acronym / sponsor ID
- ADVANCE-ED / CP- 909-001
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision to terminate the study
- Enrolment
- 18 participants (actual)
- Lead sponsor
- HeartFlow, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 13 Apr 2022 (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.
This is a prospective multi-center study. All clinically stable, symptomatic patients who present to the emergency department (ED) or observation unit with suspected coronary artery disease (CAD) and who have at least one ≥40% lesion and no lesion >90% confirmed by CCTA (Coronary Computed Tomography Angiogram) are eligible for enrollment once their CCTA has been completed and their FFR-CT (if applicable) has been ordered. All enrolling sites will have CCTA incorporated into their standard evaluation of chest pain in the ED/observation unit. Non-control sites will have CCTA and FFR-CT analysis incorporated into their standard evaluation of chest pain in the ED/observation unit.
Detailed description
This is a prospective multi-center study. All clinically stable, symptomatic patients who present to the ED or observation unit with suspected CAD and who have at least one ≥40% lesion and no lesions <90% lesion in a major vessel, confirmed by CCTA, are eligible for enrollment once their CCTA has been completed and FFR-CT (if applicable) has been ordered. All enrolling sites will have CCTA incorporated into their standard evaluation of chest pain in the ED/observation unit. Non-control sites will have CCTA and FFR-CT analysis incorporated into their standard evaluation of chest pain in the ED/observation unit.
All participating sites will provide demographics, medical history, CCTA images, FFR-CT (for non-control sites), the decision plan post CCTA and pre FFR-CT (for non-control sites), length of stay for patients in the ED/observation unit/hospital, billing reports (UB-04 preferred), 30-day clinical outcomes, and any other hospital or office visits, imaging, and/or procedural data completed prior to the follow-up 30-day visit. Sites which do not have FFR-CT incorporated into the ED/observation unit will be control sites.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FFR-CT Group | – | Diagnostic Test: FFR-CTSites who have CCTA and FFR-CT analysis incorporated into their standard evaluation of chest pain in the ED/observation unit. |
| Control Group | – | –Sites who have CCTA but not FFR-CT incorporated into the ED/observation unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinically stable, symptomatic patients who present to the ED with suspected coronary artery disease and no history of coronary artery disease, and who while in the ED have a CCTA performed which shows at least one ≥40% lesion and no lesions >90% in a major epicardial vessel, and a successfully processed FFR-CT (if applicable).
Key inclusion criteria (8 listed)
- Age ≥18 years
- Clinically stable, symptomatic patients who present to ED/observation unit with suspected CAD
- CCTA shows at least one ≥40% lesion and no lesions >90% in at least one major epicardial vessel
- FFR-CT processed successfully (if applicable)
- EKG with no acute ischemic changes
Key exclusion criteria (13 listed)
- CCTA showing no ≥40% lesion in a major epicardial vessel
- CCTA showing a lesion >90% in a major epicardial vessel
- CCTA showing other incidental, non-cardiac findings requiring admission, e.g., pneumonia, pulmonary embolism, or aortic dissection
- Uninterpretable CCTA which is not of diagnostic quality
- Coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) prior to CCTA acquisition
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 |
|---|---|---|
| FFR-CTFFR-CT is a diagnostic test following a CCTA to help diagnose and treat coronary artery disease. | Diagnostic test | FFR-CT Group |
Primary outcome
Reclassification rate between the coronary management plan based on the review of the CCTA alone compared to the coronary management plan based on the review of the CCTA and the FFR-CT analysis.
Time frame: 30 days
For each enrolled patient, investigators used data from coronary CTA,along with the clinical data such as medical history and demographics todetermine the management plan for the patient. The investigator wouldthen also view the patient's FFR-CT results and determine themanagement plan for the patient with the additional information from theFFR-CT. None of the data was collected or analyzed due to the study'searly termination. No additional procedures occurred due to studytermination, and Patients were treated per standard clinical care.
4 secondary outcomes
Cost Utility Analysis
Time frame: 30 days
Rate of Major Adverse Coronary Events (MACE)
Time frame: 30 days
Time to primary diagnosis
Time frame: Within 30 days
Time to discharge
Time frame: Within 30 days
Results and safety
The study was stopped early (reason given: Sponsor decision to terminate the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 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.
Sadeer Al-Kindi, MD principal investigator
University Hospitals Cleveland
Sneha Chinai, MD principal investigator
UMass Memorial Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by HeartFlow, Inc. at 2 sites 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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Sponsor decision to terminate the study). Results are not available in the source record.
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?
Reclassification rate between the coronary management plan based on the review of the CCTA alone compared to the coronary management plan based on the review of the CCTA and the FFR-CT analysis. (time frame: 30 days). 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 22 May 2026.