Clinical trial NCT06979427: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Coronary Syndrome
Keywords: Chronic Coronary Syndrome
Major adverse coronary events (MACE)
fractional flow reserve
coronary CT angiography
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2025-05-19
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: NIFFR of coronary less than 0.8
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of patients with MACE
timeFrame: 1 year
measure: Number of patients with bleeding
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients with dyspnoea
timeFrame: 1 year
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Professor Kojuri Cardiology Clinic
state: Fars
Study officials:
References: