CTFFR and Prediction of Non-Significant CAD Lesions

Official title

Evaluation of the Ability of CTFFR to Determine Non-significant Lesions of Coronary Disease Based on MACE in One-year Follow-up of Patients (Seeing Beyond the Stenosis: CTFFR and MACE in a One-Year Follow-Up)

Overview

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

Detailed description

This prospective cohort includes people with known or suspected CAD who had both CCTA and ICA with this index (FFR) measurements. 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.

Data about the patients was acquired from the Professor Kojuri registry. The database provided demographic information for instance age, gender, CAD family history, prior CAD history, hypertension (HTN), diabetes mellitus (DM), and hyperlipidaemia (HLP). The prevalence of cigarette smoking and the ejection fraction of the left ventricle. Lesion and Vessel Characteristics were also collected from registry.

The target vessel was identified (LAD, RCA, LCX, or LMC), the lesion was located (proximal, mid, or bifurcation), the vessel diameters were measured (proximal, distal, stenotic), and the lesion length was determined. Measurements were taken using CCTA datasets using semi-automated software methods.

Patients were clinically monitored for one year after examination. The primary outcome was the occurrence of major cardiovascular consequences, or MACE, which included cardiac-related death, acute coronary syndrome (ACS), unexpected revascularisation, and hospitalization for cardiac reasons. Throughout the one-year study period, all participants were visited every three months and followed up with phone calls.

Interventions

• Diagnostic test NIFFR
  Fractional flow reserve derived from CT angiography from lesion between 50-70%

Primary outcome measures

• Number of patients with MACE [Time frame: 1 year]
• Number of patients with bleeding [Time frame: 1 year]

Secondary outcome measures (1)

• Number of patients with dyspnoea [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Diagnostic

Study locations

Iran · 1 center

• Professor Kojuri Cardiology Clinic — Shiraz

Publications

• Khalafinezhad H, Zarifkar H, Vafa RG, Zarifkar H, Mirrhosseini A, Kojuri J. Evaluation of the ability of CTFFR to determine non-significant lesions of coronary disease based on MACE in one-year follow-up of patients (seeing beyond the stenosis: CTFFR and MACE in a one-year follow-up). BMC Cardiovasc Disord. 2026 Mar 26;26(1):393. doi: 10.1186/s12872-026-05782-0. PMID 41888687

Identifiers

NCT: NCT06979427 · 1403.414

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗