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Completed

NCT Number: NCT03045601

Diagnostic Accuracy of CT-FFR 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital, Klinikk for hjertemedisin

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT-FFR

Diagnostic Test

Invasive FFR and CCTA With CT-FFR

Stress echocardiography

Diagnostic Test

Stress echocardiography and invasive FFR

Primary outcomes

  1. CT- FFR values by New Method as a dichotomous variable

    Time frame: 4 weeks

    Determining the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve

  2. Worsening regional wall motion abnormality

    Time frame: 4 weeks

    Determining the diagnostic accuracy of invasive FFR with comprehensive stress echocardiographic techniques

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 7, 2017
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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