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

NCT03045601 | Completed

• 1 other identifier: 2016/1609
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Disease

Keywords

Diagnostic Techniques, Cardiovascular; Coronary Angiography; Fractional Flow Reserve, Myocardial; Echocardiography, Stress

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

CT-FFR

EXPERIMENTAL

Analyse With New CT-FFR Method

Diagnostic Test: CT-FFR

Stress echocardiography

ACTIVE COMPARATOR

Analyse With invasive FFR and stress echocardiography

Diagnostic Test: Stress echocardiography

Interventions

CT-FFR DIAGNOSTIC_TEST

Invasive FFR and CCTA With CT-FFR

CT-FFR

Stress echocardiography DIAGNOSTIC_TEST

Stress echocardiography and invasive FFR

Stress echocardiography

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St Olavs Hospital, Klinikk for hjertemedisin

Trondheim, Norway

Location

Related Publications (2)

• Braten AT, Fossan FE, Muller LO, Jorgensen A, Stensaeth KH, Hellevik LR, Wiseth R. Automated computed tomography-derived fractional flow reserve model for diagnosing haemodynamically significant coronary artery disease: a prospective validation study. Eur Heart J Imaging Methods Pract. 2024 Sep 30;2(3):qyae102. doi: 10.1093/ehjimp/qyae102. eCollection 2024 Jul.

  PMID: 39450294 DERIVED

• Tjellaug Braten A, Holte E, Wiseth R, Aakhus S. Dobutamine stress echocardiography after positive CCTA: diagnostic performance using fractional flow reserve and instantaneous wave-free ratio as reference standards. Open Heart. 2024 Sep 30;11(2):e002899. doi: 10.1136/openhrt-2024-002899.

  PMID: 39349050 DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

Echocardiography, Stress

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Petter Aadahl, MD, PhD

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: February 7, 2017
• Study Start: February 21, 2017
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 9, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)