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

• ClinicalTrials.gov Identifier: NCT05138289
• Recruitment Status: Completed
• First Posted: November 30, 2021
• Last Update Posted: December 15, 2022
• Sponsor: HeartFlow, Inc.
• Information provided by (Responsible Party): HeartFlow, Inc.

Study Description

Brief Summary:

This study will evaluate the level of agreement between noninvasive CCTA-based quantification and characterization of coronary atherosclerosis and invasive IVUS .

Condition or disease
Coronary Artery Disease

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 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, FFR, any NHPR (e.g., dPR, RFR, iFR, 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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 258 participants
• Observational Model: Other
• Time Perspective: Prospective
• Target Follow-Up Duration: 1 Day
• Official Title: The REVEALPLAQUE Study: A pRospEctiVe, multicEnter Study to AnaLyze PLAQUE Using CCTA
• Actual Study Start Date: October 12, 2021
• Actual Primary Completion Date: November 8, 2022
• Actual Study Completion Date: November 8, 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. total plaque volume [ Time Frame: During IVUS procedure ]
   Compare total plaque volume with IVUS obtained during ICA

Other Outcome Measures:

1. calcified plaque volume, plow attenuated plaque volume, fibrous plaque volume, [ Time Frame: During IVUS procedure ]
   Compare with IVUS obtained during ICA
2. percent plaque burden, [ Time Frame: During IVUS procedure ]
   Compare with IVUS obtained during ICA
3. minimum lumen area [ Time Frame: During IVUS procedure ]
   Compare with IVUS obtained during ICA
4. positive remodeling index and percent area stenosis [ Time Frame: During IVUS procedure ]
   Compare with IVUS obtained during ICA

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

Inclusion criteria (all must be present):

1. Age ≥18 years
2. Clinically stable patient with known CAD
3. 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
4. FFRct successfully processed
5. Willing to comply with all aspects of the protocol
6. Agrees to be included in the study and able to provide written informed consent.

Exclusion criteria (all must be absent):

1. 1. CCTA showing no stenosis
2. Uninterpretable CCTA by HeartFlow assessment, in which image quality prevents FFRCT from being processed.
3. Acute chest pain
4. CABG prior to CCTA acquisition
5. Prior history of PCI for 3 or more vessels
6. MI less than 30 days prior to CCTA or between CCTA and ICA.
7. Suspicion of acute coronary syndrome (acute myocardial infarction or unstable angina)
8. Known complex congenital heart disease
9. Tachycardia or significant arrhythmia
10. Subject requires an emergent procedure
11. 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 III or IV) or acute pulmonary edema
12. Any active, serious, life-threatening disease with a life expectancy of less than 2 months
13. Currently enrolled in another study utilizing FFRCT or in an investigational trial that involves a non-approved cardiac drug or device
14. Persons under the protection of justice, guardianship, or curatorship

Contacts and Locations

Locations

United States, Nebraska

HeartFlow Investigative Site

Lincoln, Nebraska, United States, 68506

Sponsors and Collaborators

HeartFlow, Inc.

Investigators

• Principal Investigator: Jagat Narula, MD; HeartFlow Investigative Site
• Principal Investigator: Thomas Stuckey, MD; HeartFlow Investigative site
• Principal Investigator: Gaku Nakazawa, MD; HeartFlow investigative site

More Information

• Responsible Party: HeartFlow, Inc.
• ClinicalTrials.gov Identifier: NCT05138289
• Other Study ID Numbers: CP- 908-001
• First Posted: November 30, 2021
• Last Update Posted: December 15, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases