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  • STATUS
    Recruiting
  • End date
    Sep 1, 2026
  • participants needed
    250
  • sponsor
    Shiraz University of Medical Sciences
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Updated on 20 May 2025
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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

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 hyperlipidemia (HLP). We also collected information on the prevalence of cigarette smoking and the ejection fraction of the left ventricle. Lesion and Vessel Characteristics 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.

Details
Condition Chronic Coronary Syndrome
Age 20years - 80years
Clinical Study IdentifierNCT06979427
SponsorShiraz University of Medical Sciences
Last Modified on20 May 2025

Eligibility

 Yes No Not Sure

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
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