CTFFR and Prediction of Non-Significant CAD Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-09-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Chronic Coronary Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

NIFFR of coronary less than 0.8

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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nonsignificant NIFFR

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

Group Type EXPERIMENTAL

NIFFR

Intervention Type DIAGNOSTIC_TEST

Fractional flow reserve derived from CT angiography from lesion between 50-70%

significant NIFFR

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

Group Type ACTIVE_COMPARATOR

NIFFR

Intervention Type DIAGNOSTIC_TEST

Fractional flow reserve derived from CT angiography from lesion between 50-70%

Interventions

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NIFFR

Fractional flow reserve derived from CT angiography from lesion between 50-70%

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Non invasive fractional flow reserve

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No