CTFFR and Prediction of Non-Significant CAD Lesions

Not Applicable

Recruiting

• Conditions: Chronic Coronary Syndrome

• Registration Number: NCT06979427
• Lead Sponsor: Shiraz University of Medical Sciences

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

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.

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-16
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-18
• Study First Posted: 2025-05-19
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-07-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of patients with MACE	1 year	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
Number of patients with bleeding	1 year	Number of patients with major or minor bleeding based on BARC classification

Secondary Outcome Measures

Name	Time	Method
Number of patients with dyspnoea	1 year	Number of patients with minor and major dyspnoea ( based on that it affect daily activity or tolerable or not)

Trial Locations

Locations (1)

Professor Kojuri Cardiology Clinic; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of