Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))REVEALPLAQUENCT05138289

The REVEALPLAQUE Study: A pRospEctiVe, multicEnter Study to AnaLyze PLAQUE Using CCTA

An observational study of Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by HeartFlow, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will evaluate the level of agreement between noninvasive CCTA (coronary computed tomography angiography)-based quantification and characterization of coronary atherosclerosis and invasive IVUS (intravascular ultrasound). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
What is being tested?: Total Plaque Volume
How many people: 258 participants
Where: 1 siteUnited States
Study dates: 12 Oct 2021to 8 Nov 2022
How long will I take part?: 1 Day
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 patients with known CAD who have a CCTA showing stenosis in at least one major epicardial vessel of stentable/graftable diameter and in whom clinically-indicated IVUS is planned.

Who may be able to join

Age ≥18 years
Clinically stable patient with known CAD
CCTA showing stenosis in at least one major epicardial vessel of stentable/graftable diameter, in whom clinically indicated IVUS is planned within 45 days of the CCTA and FFRct available
FFRct successfully processed
Willing to comply with all aspects of the protocol
Agrees to be included in the study and able to provide written informed consent.

Who cannot join

1. CCTA showing no stenosis
Uninterpretable CCTA by HeartFlow assessment, in which image quality prevents FFRCT from being processed.
Acute chest pain
CABG (coronary artery bypass graft) prior to CCTA acquisition
Prior history of PCI for 3 or more vessels
MI (myocardial infarction) less than 30 days prior to CCTA or between CCTA and ICA.

Show all 14Show fewer

Suspicion of acute coronary syndrome (acute myocardial infarction or unstable angina)
Known complex congenital heart disease
Tachycardia or significant arrhythmia
Subject requires an emergent procedure
Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, and severe congestive heart failure (NYHA [New York Heart Association] III or IV) or acute pulmonary edema
Any active, serious, life-threatening disease with a life expectancy of less than 2 months
Currently enrolled in another study utilizing FFRCT 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

1 site in 1 country.

United States1 site

HeartFlow Investigative Site
Lincoln, Nebraska, 68506

Other trials in United States

About this study

Read the detailed description

This is a prospective, multi-center study. All patients who have a stenosis in at least one major epicardial vessel confirmed by CCTA, who have undergone FFRCT (Fractional flow reserve-computed tomography) analysis, and who are scheduled to undergo clinically indicated IVUS-guided invasive evaluation and/or treatment will be eligible for enrollment. Enrolling sites will have FFRCT analysis incorporated when indicated into their standard evaluation of CCTA scans. Data collected will include CCTA and FFRCT, full angiographic, and IVUS images, and if obtained, any other imaging or physiologic data including OCT (Optical coherence tomography), FFR (fractional flow reserve), any NHPR (non-hyperemic pressure ratios) (e.g., dPR (diastolic pressure ratio), RFR (resting full-cycle ratio), iFR (instantaneous wave-free ratio), etc.), and pre- and post-stent implantation invasive data. All non-invasive and invasive data collected will be obtained as clinical practice consistent with standard clinical care.

Conditions: Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Being tested: Total Plaque Volume
Medical subject headings: Coronary Artery Disease, Angina Pectoris, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Total Plaque VolumeOther
Compare total plaque volume with IVUS obtained during ICA (invasive coronary angiography)

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of Total Plaque Volume
Level of agreement between total plaque volume measured by AI-QCPA (Artificial intelligence quantitative coronary plaque analysis) and IVUS (intravascular ultrasound).
Measured: 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 20218 Nov 2022

First posted30 Nov 2021
Study start12 Oct 2021
Primary completion8 Nov 2022
Study completion8 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))Studies 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: Other
Time perspective: Prospective
Enrolment: 258 participants (actual)
Target duration: 1 Day

IDs, dates and publications

ClinicalTrials.gov ID: NCT05138289
Sponsor's protocol ID: CP- 908-001
Acronym: REVEALPLAQUE
Status last verified: Aug 2025
First submitted: 24 Sep 2021
Last updated: 22 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)) trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The REVEALPLAQUE Study: A pRospEctiVe, multicEnter Study to AnaLyze PLAQUE Using CCTA
ClinicalTrials.gov ID: NCT05138289
Acronym / sponsor ID: REVEALPLAQUE / CP- 908-001
Conditions: Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Study type: Observational
Recruitment status: Completed
Enrolment: 258 participants (actual)
Lead sponsor: HeartFlow, Inc.Industry (pharma, biotech, devices)
Study start: 12 Oct 2021 (actual)
Primary completion: 8 Nov 2022 (actual)
Study completion: 8 Nov 2022 (actual)
First posted: 30 Nov 2021 (actual)
Results: Posted 29 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective
Target follow-up: 1 Day

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Clinically stable patients with known CAD who have a CCTA showing stenosis in at least one major epicardial vessel of stentable/graftable diameter and in whom clinically-indicated IVUS is planned.

Key inclusion criteria (6 listed)

Age ≥18 years
Clinically stable patient with known CAD
CCTA showing stenosis in at least one major epicardial vessel of stentable/graftable diameter, in whom clinically indicated IVUS is planned within 45 days of the CCTA and FFRct available
FFRct successfully processed
Willing to comply with all aspects of the protocol

Key exclusion criteria (14 listed)

1. CCTA showing no stenosis
Uninterpretable CCTA by HeartFlow assessment, in which image quality prevents FFRCT from being processed.
Acute chest pain
CABG (coronary artery bypass graft) prior to CCTA acquisition
Prior history of PCI for 3 or more vessels

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
Total Plaque VolumeCompare total plaque volume with IVUS obtained during ICA (invasive coronary angiography)	Other	–

Primary outcome

Comparison of Total Plaque Volume
Time frame: 13 months
Level of agreement between total plaque volume measured by AI-QCPA (Artificial intelligence quantitative coronary plaque analysis) and IVUS (intravascular ultrasound).

Results and safety

Results posted to the registry on 29 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IVUS	258	258

Primary outcome: Comparison of Total Plaque Volume

Time frame: 13 months. Number. Unit: Pearson's correlation statistic

Measure	IVUS n = 237
Value	0.91

Population analysed: Baseline participants is not the same as the Participant flow as 21 participants were excluded from analysis due to technical limitations and we were not able to process medical imaging data.

Adverse events

Time frame: No adverse event data was collected. This was an observational study and all patients received standard clinical care, no intervention was given.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IVUS	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

Recruiting
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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.

Jagat Narula, MD principal investigator

HeartFlow Investigative Site

Thomas Stuckey, MD principal investigator

HeartFlow Investigative site

Gaku Nakazawa, MD principal investigator

HeartFlow investigative site

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 Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by HeartFlow, Inc. 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 6 inclusion and 14 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: finished, as of the sponsor's last update on 22 Aug 2025. 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?

Yes. Results are posted in the registry (first posted 29 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Comparison of Total Plaque Volume (time frame: 13 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05138289.

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 Aug 2025.