An interventional study of NIFFR in Chronic Coronary Syndrome, sponsored by Shiraz University of Medical Sciences. Recruiting at 1 site in Iran, Islamic Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Shiraz University of Medical Sciences · Not applicable, Interventional, and Diagnostic
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
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.
Shiraz University of Medical Sciences is the lead sponsor of 130 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients with coronary artery lesion in CT angiography, with NIFFR of more than 0.8
Diagnostic Test: NIFFR
patients with coronary artery lesion in CT angiography, with NIFFR of more than 0.8
Diagnostic Test: NIFFR
Fractional flow reserve derived from CT angiography from lesion between 50-70%
Also known as: Non invasive fractional flow reserve
Number of patients with MACE
Number of patients with Major adverse cardiac events,which included cardiac-related death, acute coronary syndrome (ACS), unexpected revascularisation, and hospitalization for cardiac reasons, stroke
Time frame: 1 year
Number of patients with bleeding
Number of patients with major or minor bleeding based on BARC classification
Time frame: 1 year
Number of patients with dyspnoea
Number of patients with minor and major dyspnoea ( based on that it affect daily activity or tolerable or not)
Time frame: 1 year
Plan to share: No — data sharing by rational request
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Jul 2026, 30 months after the start.
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