Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05138289
Recruitment Status : Recruiting
First Posted : November 30, 2021
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
HeartFlow, Inc.

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 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
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine





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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05138289


Contacts
Layout table for location contacts
Contact: Sarah Mullen 408.314.2335 smullen@heartflow.com
Contact: Saba Mirza 6508679419 smirza@heartflow.com

Locations
Layout table for location information
United States, Nebraska
HeartFlow Investigative Site Recruiting
Lincoln, Nebraska, United States, 68506
Contact: Rose Saalfeld, MBA    402-483-3294    rose.saalfeld@bryanheart.com   
Sponsors and Collaborators
HeartFlow, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Jagat Narula, MD HeartFlow Investigative Site
Principal Investigator: Thomas Stuckey, MD HeartFlow Investigative site
Principal Investigator: Gaku Nakazawa, MD HeartFlow investigative site
Layout table for additonal information
Responsible Party: HeartFlow, Inc.
ClinicalTrials.gov Identifier: NCT05138289    
Other Study ID Numbers: CP- 908-001
First Posted: November 30, 2021    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases