Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT06979427
Status:
RECRUITING
Last Update Posted:
2025-05-21
First Post:
2025-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CTFFR and Prediction of Non-Significant CAD Lesions
Sponsor:
Shiraz University of Medical Sciences
Organization:
Study Overview
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)
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: