Diagnostic Accuracy of CT-FFR Compared to Invasive Coronar Angiography With Fractional Flow Reserve

Diagnostic Accuracy of Coronary Computed Tomographic Angiography Derived Fractional Flow Reserve Compared to Invasive Coronar Angiography With Fractional Flow Reserve

Invasive coronary angiography is currently considered gold standard in the assessment of coronary artery disease although the method has limitations. Most importantly invasive angiography only depicts coronary anatomy without determining its physiological significance i.e the likelihood that the stenosis impedes oxygen delivery to the heart muscle. Fractional flow reserve (FFR) is a catheterization technique for assessing the physiological significance of a coronary artery lesion during invasive coronary angiography. Coronary computed tomographic angiography (CCTA) is a noninvasive imaging test that has become an alternative route to diagnosis for patients with suspected coronary artery disease. Computational fluid dynamics combined with anatomical models based on CCTA scans allows determination of coronary flow and pressure, and has emerged as a promising diagnostic modality called CT-FFR. In this Project New Mathematical algorithms are developed for computation of CT-FFR. The main objective of this study is to determine the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve and state-of-the-art dobutamin stress echocardiography.

Study Overview

• Status: Completed
• Conditions: Coronary Disease
• Intervention / Treatment: Diagnostic test: CT-FFR; Diagnostic test: Stress echocardiography

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs Hospital, Klinikk for hjertemedisin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• Proven stenosis by CCTA that require further investigation with invasive coronary angiography i.e. patients with estimated stenosis ≥30- 50%.
• Informed consent

Exclusion Criteria:

• Patients with unstable coronary artery disease.
• Previously treated with PCI or coronary surgery.
• Severe renal impairment i.e. GFR <30ml / min
• Contrast allergy
• Contraindication to adenosine / nitroglycerin / beta-blocker
• BMI> 40
• Patients referred on the basis of technically unsuccessful CTA, motion artifact or similar

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT-FFR; Analyse With New CT-FFR Method	Diagnostic test: CT-FFR; Invasive FFR and CCTA With CT-FFR
Active Comparator: Stress echocardiography; Analyse With invasive FFR and stress echocardiography	Diagnostic test: Stress echocardiography; Stress echocardiography and invasive FFR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT- FFR values by New Method as a dichotomous variable	Determining the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve	4 weeks
Worsening regional wall motion abnormality	Determining the diagnostic accuracy of invasive FFR with comprehensive stress echocardiographic techniques	4 weeks

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology
• Investigators: Study Director: Petter Aadahl, MD, PhD, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2017
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Coronary Angiography; Fractional Flow Reserve, Myocardial; Diagnostic Techniques, Cardiovascular; Echocardiography, Stress
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: 2016/1609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No