History of Changes for Study: NCT05138289

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

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Study Record Versions

Version	Submitted Date	Changes
1	November 17, 2021	None (earliest Version on record)
2	November 30, 2021	Contacts/Locations and Study Status
3	December 13, 2022	Recruitment Status, Study Status, Contacts/Locations and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CP- 908-001
Brief Title:	The REVEALPLAQUE Study: A pRospEctiVe, multicEnter Study to AnaLyze PLAQUE Using CCTA (REVEALPLAQUE)
Official Title:	The REVEALPLAQUE Study: A pRospEctiVe, multicEnter Study to AnaLyze PLAQUE Using CCTA
Secondary IDs:

Study Status


Record Verification:	November 2021
Overall Status:	Recruiting
Study Start:	October 12, 2021
Primary Completion:	October 1, 2022 [Anticipated]
Study Completion:	January 1, 2023 [Anticipated]

First Submitted:	September 24, 2021
First Submitted that Met QC Criteria:	November 17, 2021
First Posted:	November 30, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	November 17, 2021
Last Update Posted:	November 30, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	HeartFlow, Inc.
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

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 .

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.

Conditions


Conditions:	Coronary Artery Disease
Keywords:

Study Design


Study Type:	Observational [Patient Registry]
Observational Study Model:	Other
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	250 [Anticipated]
Number of Groups/Cohorts	0
Target Follow-Up Duration:	1 Day

Groups and Interventions

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


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.
Sampling Method:	Non-Probability Sample
Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion criteria (all must be present): 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. Exclusion criteria (all must be absent): 1. CCTA showing no stenosis Uninterpretable CCTA by HeartFlow assessment, in which image quality prevents FFRCT from being processed. Acute chest pain CABG prior to CCTA acquisition Prior history of PCI for 3 or more vessels MI 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 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

Contacts/Locations


Central Contact Person:	Sarah Mullen Telephone: 408.314.2335 Email: smullen@heartflow.com
Central Contact Backup:	Gerri ORiordan Telephone: 6508679419 Email: gerrisnowball@gmail.com
Study Officials:	Jagat Narula, MD Principal Investigator HeartFlow Investigative Site
	Thomas Stuckey, MD Principal Investigator HeartFlow Investigative site
	Gaku Nakazawa, MD Principal Investigator HeartFlow investigative site
Locations:	United States, Nebraska
	HeartFlow Investigative Site [Recruiting] Lincoln, Nebraska, United States, 68506 Contact:Contact: Rose Saalfeld, MBA 402-483-3294 rose.saalfeld@bryanheart.com

IPDSharing


Plan to Share IPD:	Undecided

References


Citations:
Links:
Available IPD/Information: