Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT02499679
• Lead Sponsor: HeartFlow, Inc.

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.

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-13
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Primary Completion: 2019-02
• Study Completion: 2019-05
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6384

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	n/a: reclassification rate of management plan

Secondary Outcome Measures

Name	Time	Method
Rate of reclassification between Investigator management plan based on cCTA alone compared to actual clinical management	90 days
Rate of invasive catheterization without obstructive disease	90 days
Major Adverse Coronary Event (MACE) rates at 90 days, 180 days and 1 - 3 years	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.
Estimated cumulative medical radiation exposure	1 year
Resource Utilization at 90 days, 180 days, 1 - 3 years	3 years	Resource utilization composite defined as the composite of invasive diagnostic and therapeutic coronary procedures, treatment of MACE events, and noninvasive cardiac testing
Percent of patients undergoing revascularization within 90 days for whom functional data are available prior to revascularization	90 days
Individual components of MACE at 90 days, 180 days, 1 - 3 years	3 years	Individual components of MACE defined as all cause death, non-fatal MI, unplanned hospitalization for ACS leading to urgent revascularization