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

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045601
• Other study ID #: 2016/1609
• Status: Completed
• Phase: N/A
• Start date: February 21, 2017
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2020
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Disease

Intervention

Diagnostic Test:
• CT-FFR
Invasive FFR and CCTA With CT-FFR
• Stress echocardiography
Stress echocardiography and invasive FFR

Locations

Country	Name	City	State
Norway	St Olavs Hospital, Klinikk for hjertemedisin	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Worsening regional wall motion abnormality	Determining the diagnostic accuracy of invasive FFR with comprehensive stress echocardiographic techniques	4 weeks