Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care (ADVANCE)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02499679|
Recruitment Status : Enrolling by invitation
First Posted : July 16, 2015
Last Update Posted : February 23, 2017
|Condition or disease|
|Coronary Artery Disease|
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.
- 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.
- To assess the real world outcomes of utilizing FFRCT to guide invasive management and/or medical treatment.
- To assess resource utilization, following standard practice for diagnostic and treatment pathways incorporating FFRCT as the preferred CAD diagnostic test.
- 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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||5000 participants|
|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|
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.
- 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 ]
- Rate of reclassification between Investigator management plan based on cCTA alone compared to actual clinical management [ Time Frame: 90 days ]
- Rate of invasive catheterization without obstructive disease [ Time Frame: 90 days ]
- Percent of patients undergoing revascularization within 90 days for whom functional data are available prior to revascularization [ Time Frame: 90 days ]
- 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.
- 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
- Estimated cumulative medical radiation exposure [ Time Frame: 1 year ]
- 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
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
|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|