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

NCT05138289 | Completed Results

• 1 other identifier: CP- 908-001
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  13 months

Interventions

Total Plaque Volume OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• \. 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.
• 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

Sponsors & Collaborators

• HeartFlow, Inc.: lead

Study Sites (1)

HeartFlow Investigative Site

Lincoln, Nebraska, 68506, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Results Point of Contact

• Title: Saba Mirza
• Organization: HeartFlow

smirza@heartflow.com

650-241-1221

Study Officials

• Jagat Narula, MD

  HeartFlow Investigative Site

  PRINCIPAL INVESTIGATOR

• Thomas Stuckey, MD

  HeartFlow Investigative site

  PRINCIPAL INVESTIGATOR

• Gaku Nakazawa, MD

  HeartFlow investigative site

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: November 30, 2021
• Study Start: October 12, 2021
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: August 22, 2025
• Results First Posted: January 29, 2025

Record last verified: 2025-08

Locations

US (1)