CTFFR and Prediction of Non-Significant CAD Lesions

Shiraz University of Medical Sciences

Status: Enrolling

Conditions: Chronic Coronary Syndrome

Treatments: Diagnostic Test: NIFFR

Study type: Interventional

Funder types: Other

Identifiers

NCT06979427

1403.414

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups

nonsignificant NIFFR

Experimental group

Description:

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

Treatment:

Diagnostic Test: NIFFR

significant NIFFR

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: NIFFR