Clinical Trial: The Value of CT Fractional Flow Reserve

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: The Value of Fractional Flow Reserve Derived From Coronary CTA and in the Triage of Low to Intermediate Risk Chest Pain Patients: Design: Single Center Prospective Clinical Trial; Target Disease: Coro

Brief Summary:

Coronary Computed Tomography Angiogram (CCTA) is a non-invasive imaging modality that has high sensitivity and negative predictive value for the detection of coronary artery disease (CAD). The main limitations of CCTA are its poor specificity and positive predictive value, as well as its inherent lack of physiologically relevant data on hemodynamic significance of coronary stenosis, a data that is provided either by non-invasive stress tests such as myocardial perfusion imaging (MPI) or invasively by measurement of the Fractional Flow Reserve (FFR). Recent advances in computational fluid dynamic techniques applied to standard CCTA are now emerging as powerful tools for virtual measurement of FFR from CCTA imaging (CT-FFR). These techniques correlate well with invasively measured FFR [1-4]. The primary purpose of this study is to evaluate the incremental benefit CT-FFR as compared to CCTA in triaging chest pain patients in outpatient settings who are found to have obstructive CAD upon CCTA (> 30% and < 90% stenosis). Invasive FFR and short term clinical outcomes (90 days) will be correlated with each diagnostic modality in order to evaluate positive and negative predictive value of each when used incrementally with CCTA.

Patients will undergo a CCTA, as part of routine care. If the patient consents to participate in the study and is found to have coronary stenosis of 30% to 90%, based on the cardiologist's reading, the CCTA study will be sent to HeartFlow, a vendor that will provide a computerized FFR reading, based on the CCTA study. If the noninvasive FFR diagnosis indicates obstructive disease, the patient will undergo cardiac catheterization with invasive FFR.

As CCTA utilization increases, the need to train additional imaging specialists will increase. This study will assess the capability of FFR-CT to enhance pe

Detailed Summary:

CCTA is increasingly becoming a preferred non-invasive imaging modality because of its high sensitivity and negative predictive value for the detection of CAD. It has been shown to be a robust imaging modality for evaluation of chest pain, and is associated with decreased unnecessary hospital admission, length of stay, major adverse cardiovascular event rates, recidivism rates, and downstream resource utilization compared to standard evaluation [5]. While findings so far are highly suggestive of CCTA's significance as a gatekeeper for Invasive Coronary Angiography (ICA) by ruling out obstructive CAD, fewer than half of obstructive stenosis identified by CCTA are ischemia-causing, signifying its poor positive predictive value and inherent lack of physiological information [6-8]. Consequently, utilization of CCTA has not entirely averted need for downstream testing for functional assessment of CCTA-detected obstructive lesions either by stress testing or ICA. Recently a major treatment modality, associated with the use of CCTA, has become available that offers promise for improving positive predictive value and physiological relevant hemodynamic data. Advances in computational fluid dynamic techniques applied to standard CCTA are now emerging as a powerful tool for virtual measurement of FFR from CCTA imaging (CT-FFR). This techniques correlate well with invasively measured FFR [1-4]. CT-FFR is not an investigational agent, having been approved by FDA in November, 2014. However, more work is necessary to delineate the patient population that could derive maximal benefit from this new technology.

While few publications regarding the use of CT-FFR specifically address the cost of diagnostic work-up for obstructive disease, it is clear that the cost structure resulting from changes in diagnostic testing will also change. Deferral or avoidance of cardiac catheterization and nuc
Sponsor: Northwell Health

Current Primary Outcome: Comparison of CT-FFR to Invasive FFR [ Time Frame: Up to 1 year from the study initiation will be required to enroll all study patients and obstain invasive and noninvasive FFR. ]

Original Primary Outcome: Comparison of CT-FFR to Invasive FFR [ Time Frame: 1/2017 to 11/2017 ]

Current Secondary Outcome:

• Inter-observer reliability [ Time Frame: Up to 1 year will be required to obtain all reader evaluations for the study in order to asses inter-observer reliability. ]
  To evaluate differences in performance of readers of CCTA and CT-FFR based on years of experience.
• Return Visits [ Time Frame: Up to 15 months will be required to collect 90 day follow up information on all study participants. ]
  To identify factors influencing return visits within 90 days for patient who had negative CCTA or Cardiac Catheterization findings.

Original Secondary Outcome:

• Inter-observer reliability [ Time Frame: 1/2017 to 11/2017 ]
  To evaluate differences in performance of readers of CCTA and CT-FFR based on years of experience.
• Return Visits [ Time Frame: 1/2017 to 11/2017 ]
  To identify factors influencing return visits within 90 days for patient who had negative CCTA or Cardiac Catheterization findings.

Information By: Northwell Health

Dates:
Date Received: January 17, 2017
Date Started: January 2017
Date Completion: January 2018
Last Updated: April 3, 2017
Last Verified: April 2017