CTFFR and Prediction of Non-Significant CAD Lesions

NCT06979427 | Recruiting DMC

• 1 other identifier: 1403.414
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective cohort study, 250 patients with suspected or known CAD and at least one intermediate coronary lesion (50-70% stenosis) who had a NiFFR value greater than 0.80 underwent coronary computed tomography angiography (CCTA) with NiFFR assessment. Patients were followed for one year to monitor for MACE

Conditions

Chronic Coronary Syndrome

Keywords

Chronic Coronary Syndrome; Major adverse coronary events (MACE); fractional flow reserve; coronary CT angiography

Outcome Measures

Primary Outcomes (2)

• Number of patients with MACE

  Number of patients with Major adverse cardiac events,which included cardiac-related death, acute coronary syndrome (ACS), unexpected revascularisation, and hospitalization for cardiac reasons, stroke

  1 year

• Number of patients with bleeding

  Number of patients with major or minor bleeding based on BARC classification

  1 year

Secondary Outcomes (1)

• Number of patients with dyspnoea

  1 year

Study Arms (2)

nonsignificant NIFFR

EXPERIMENTAL

patients with coronary artery lesion in CT angiography, with NIFFR of more than 0.8

Diagnostic Test: NIFFR

significant NIFFR

ACTIVE COMPARATOR

patients with coronary artery lesion in CT angiography, with NIFFR of more than 0.8

Diagnostic Test: NIFFR

Interventions

NIFFR DIAGNOSTIC_TEST

Fractional flow reserve derived from CT angiography from lesion between 50-70%

Also known as: Non invasive fractional flow reserve

nonsignificant NIFFR; significant NIFFR

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were enrolled if they had at least one intermediate coronary lesion (classified as 50-70% diameter stenosis on visual judgment) on CCTA and then underwent FFR testing

You may not qualify if:

• Patients having past coronary artery bypass graft surgery (CABG)
• previous PCI in the target vascular
• significant renal impairment define with eGFR \< 30 mL/min/1.73 m²
• contrast allergy
• poor image quality that prevented appropriate CCTA or CT-FFR analysis

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Professor Kojuri Cardiology Clinic

Shiraz, Fars, 55318, Iran

RECRUITING

Central Study Contacts

javad UOM kojuri

CONTACT

09171115083; kojurij@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: NIFFR of coronary less than 0.8

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 19, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)