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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045601
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : January 3, 2020
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

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.

Condition or disease Intervention/treatment Phase
Coronary Disease Diagnostic Test: CT-FFR Diagnostic Test: Stress echocardiography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Diagnostic Accuracy of Coronary Computed Tomographic Angiography Derived Fractional Flow Reserve Compared to Invasive Coronar Angiography With Fractional Flow Reserve
Actual Study Start Date : February 21, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

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




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045601


Contacts
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Contact: Anders Tjellaug Bråten, MD 0047 92687530 anders.t.braten@ntnu.no
Contact: Rune Wiseth, MD, PhD rune.wiseth@ntnu.no

Locations
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Norway
St Olavs Hospital, Klinikk for hjertemedisin Recruiting
Trondheim, Norway
Contact: Anders Tjellaug Bråten, MD       anders.t.braten@ntnu.no   
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
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Study Director: Petter Aadahl, MD, PhD Norwegian University of Science and Technology

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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03045601    
Other Study ID Numbers: 2016/1609
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Diagnostic Techniques, Cardiovascular
Coronary Angiography
Fractional Flow Reserve, Myocardial
Echocardiography, Stress
Additional relevant MeSH terms:
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Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases