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Trial record 1 of 1 for:    NCT02499679
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Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care (ADVANCE)

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ClinicalTrials.gov Identifier: NCT02499679
Recruitment Status : Enrolling by invitation
First Posted : July 16, 2015
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of the HeartFlow ADVANCE Registry is to evaluate utility, clinical outcomes and resource utilization of FFRCT-guided evaluation in clinically stable, symptomatic patients with coronary artery disease (CAD) in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of CAD.

Condition or disease
Coronary Artery Disease

Detailed Description:

REGISTRY OBJECTIVE

The objective of the HeartFlow ADVANCE Registry is to evaluate utility, clinical outcomes and resource utilization of FFRCT-guided evaluation in clinically stable, symptomatic patients with CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of CAD.

SPECIFIC OBJECTIVES:

  1. To determine if the availability of FFRCT, in addition to coronary anatomy from the cCTA, will lead to a significant change in the coronary management plan.
  2. To assess the real world outcomes of utilizing FFRCT to guide invasive management and/or medical treatment.
  3. To assess resource utilization, following standard practice for diagnostic and treatment pathways incorporating FFRCT as the preferred CAD diagnostic test.
  4. To provide society including patients, health care providers, and other stakeholders with information about which diagnostic technologies are most effective and efficient in managing patients with CAD.

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Assessing Diagnostic Value of Non-invasive FFRCT in Coronary CarE (ADVANCE)
Study Start Date : July 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Patients diagnosed with CAD by cCTA
All clinically stable, symptomatic patients diagnosed with CAD by coronary computed tomography angiography (cCTA), that meet eligibility criteria, and are able and willing to participate are candidates for the ADVANCE Registry. Those patients that meet all inclusion/exclusion criteria and who sign the ethics committee (EC)/institutional review board (IRB) approved informed consent will be enrolled in the registry. FFRCT shall be used in accordance with the current Instructions for Use (IFU) document.


Outcome Measures

Primary Outcome Measures :
  1. Reclassification rate between the coronary management plan based on the review of the cCTA compared to the management plan based on FFRCT when obtained, as assessed by an independent review committee. [ Time Frame: n/a: reclassification rate of management plan ]

Secondary Outcome Measures :
  1. Rate of reclassification between Investigator management plan based on cCTA alone compared to actual clinical management [ Time Frame: 90 days ]
  2. Rate of invasive catheterization without obstructive disease [ Time Frame: 90 days ]
  3. Percent of patients undergoing revascularization within 90 days for whom functional data are available prior to revascularization [ Time Frame: 90 days ]
  4. Major Adverse Coronary Event (MACE) rates at 90 days, 180 days and 1 - 3 years [ Time Frame: 3 years ]
    MACE is defined as the composite rate of all cause death, non-fatal myocardial infarction (MI) and unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization.

  5. Individual components of MACE at 90 days, 180 days, 1 - 3 years [ Time Frame: 3 years ]
    Individual components of MACE defined as all cause death, non-fatal MI, unplanned hospitalization for ACS leading to urgent revascularization

  6. Estimated cumulative medical radiation exposure [ Time Frame: 1 year ]
  7. Resource Utilization at 90 days, 180 days, 1 - 3 years [ Time Frame: 3 years ]
    Resource utilization composite defined as the composite of invasive diagnostic and therapeutic coronary procedures, treatment of MACE events, and noninvasive cardiac testing


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All clinically stable, symptomatic patients diagnosed with CAD by cCTA, that meet eligibility criteria, and are able and willing to participate are candidates for the ADVANCE Registry. Those patients that meet all inclusion/exclusion criteria and who sign the EC/IRB approved informed consent will be enrolled in the registry. FFRCT shall be used in accordance with the current Instructions for Use document.
Criteria

Inclusion Criteria:

  1. Provide written informed consent
  2. Clinically stable, symptomatic patients who undergo cCTA and are diagnosed with CAD and meet eligibility criteria for FFRCT.

Exclusion Criteria:

  1. cCTA showing no CAD
  2. Uninterpretable cCTA by site assessment, in which severe artifacts prevent angiographic evaluation
  3. Any active, serious, life-threatening disease with a life expectancy of less than 1 year
  4. Inability to comply with follow-up requirements
Contacts and Locations

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): NCT02499679


Sponsors and Collaborators
HeartFlow, Inc.
Investigators
Principal Investigator: Manesh Patel, MD Duke University Health System
Principal Investigator: Jonathon Leipsic, MD Providence Health & Services
Principal Investigator: Koen Nieman, MD Erasmus Medical Center
Principal Investigator: Takashi Akasaka, MD Wakayama Medical University
More Information

Responsible Party: HeartFlow, Inc.
ClinicalTrials.gov Identifier: NCT02499679     History of Changes
Other Study ID Numbers: CP-905-001
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases