Trial Outcomes & Findings for The REVEALPLAQUE Study: A pRospEctiVe, multicEnter Study to AnaLyze PLAQUE Using CCTA (NCT NCT05138289)

Last Updated: 2025-08-22

Results Overview

Level of agreement between total plaque volume measured by AI-QCPA (Artificial intelligence quantitative coronary plaque analysis) and IVUS (intravascular ultrasound).

Recruitment status

COMPLETED

Target enrollment

258 participants

Primary outcome timeframe

13 months

Results posted on

2025-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	IVUS All patients who have a stenosis in at least one major epicardial vessel confirmed by CCTA, who have undergone FFRCT analysis, and who are scheduled to undergo clinically indicated IVUS-guided invasive evaluation and/or treatment will be eligible for enrollment.
Overall Study STARTED	258
Overall Study COMPLETED	258
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IVUS n=237 Participants All patients who have a stenosis in at least one major epicardial vessel confirmed by CCTA, who have undergone FFRCT analysis, and who are scheduled to undergo clinically indicated IVUS-guided invasive evaluation and/or treatment will be eligible for enrollment.
Age, Continuous	67.5 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	176 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	227 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	157 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	9 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	63 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 13 months

Population: 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.

Level of agreement between total plaque volume measured by AI-QCPA (Artificial intelligence quantitative coronary plaque analysis) and IVUS (intravascular ultrasound).

Outcome measures

Outcome measures
Measure	IVUS n=237 Participants All patients who have a stenosis in at least one major epicardial vessel confirmed by CCTA, who have undergone FFRCT analysis, and who are scheduled to undergo clinically indicated IVUS-guided invasive evaluation and/or treatment will be eligible for enrollment.
Comparison of Total Plaque Volume	0.91 Pearson's correlation statistic

Adverse Events

IVUS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Saba Mirza

HeartFlow

Phone: 650-241-1221

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place