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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-21

Study Completion Date

2021-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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CT-FFR

Analyse With New CT-FFR Method

Group Type EXPERIMENTAL

CT-FFR

Intervention Type DIAGNOSTIC_TEST

Invasive FFR and CCTA With CT-FFR

Stress echocardiography

Analyse With invasive FFR and stress echocardiography

Group Type ACTIVE_COMPARATOR

Stress echocardiography

Intervention Type DIAGNOSTIC_TEST

Stress echocardiography and invasive FFR

Interventions

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CT-FFR

Invasive FFR and CCTA With CT-FFR

Intervention Type DIAGNOSTIC_TEST

Stress echocardiography

Stress echocardiography and invasive FFR

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No