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

Primary Purpose

Coronary Disease

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
CT-FFR
Stress echocardiography
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Disease focused on measuring Diagnostic Techniques, Cardiovascular, Coronary Angiography, Fractional Flow Reserve, Myocardial, Echocardiography, Stress

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Olavs Hospital, Klinikk for hjertemedisin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CT-FFR

Stress echocardiography

Arm Description

Analyse With New CT-FFR Method

Analyse With invasive FFR and stress echocardiography

Outcomes

Primary Outcome Measures

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
Worsening regional wall motion abnormality
Determining the diagnostic accuracy of invasive FFR with comprehensive stress echocardiographic techniques

Secondary Outcome Measures

Full Information

First Posted
January 26, 2017
Last Updated
March 8, 2021
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03045601
Brief Title
Diagnostic Accuracy of CT-FFR Compared to Invasive Coronar Angiography With Fractional Flow Reserve
Official Title
Diagnostic Accuracy of Coronary Computed Tomographic Angiography Derived Fractional Flow Reserve Compared to Invasive Coronar Angiography With Fractional Flow Reserve
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Diagnostic Techniques, Cardiovascular, Coronary Angiography, Fractional Flow Reserve, Myocardial, Echocardiography, Stress

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT-FFR
Arm Type
Experimental
Arm Description
Analyse With New CT-FFR Method
Arm Title
Stress echocardiography
Arm Type
Active Comparator
Arm Description
Analyse With invasive FFR and stress echocardiography
Intervention Type
Diagnostic Test
Intervention Name(s)
CT-FFR
Intervention Description
Invasive FFR and CCTA With CT-FFR
Intervention Type
Diagnostic Test
Intervention Name(s)
Stress echocardiography
Intervention Description
Stress echocardiography and invasive FFR
Primary Outcome Measure Information:
Title
CT- FFR values by New Method as a dichotomous variable
Description
Determining the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve
Time Frame
4 weeks
Title
Worsening regional wall motion abnormality
Description
Determining the diagnostic accuracy of invasive FFR with comprehensive stress echocardiographic techniques
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petter Aadahl, MD, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs Hospital, Klinikk for hjertemedisin
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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