CTFFR and Prediction of Non-Significant CAD Lesions (123)

Study of Heart Artery CT Imaging to Predict Risk From CAD Narrowing

Age
20 years - 80 years
Gender
All
participants needed
250
Location
1

Brief description of study

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 of study

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 hyperlipidemia (HLP). We also collected information on the prevalence of cigarette smoking and the ejection fraction of the left ventricle. Lesion and Vessel Characteristics 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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Coronary Syndrome
  • Age: 20 years - 80 years
  • Gender: All

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

The purpose of this research study is to learn whether a heart CT scan measurement can help predict the risk of major heart problems in people with known or suspected coronary artery disease (CAD) who have a medium-level narrowing in at least 1 heart artery.

Participants will have a heart CT scan (coronary computed tomography angiography, or CCTA) that is used to measure blood flow in the heart arteries (sometimes called CT-based fractional flow reserve). Participants will also have an invasive coronary angiogram test (ICA) with a blood flow measurement (FFR). The study team will collect health information such as age, medical history, and heart-related risk factors from an existing registry. Participants will be followed for 1 year to see if they have major heart-related events, such as heart-related death, acute coronary syndrome, unexpected procedures to open blocked arteries, or hospital stays for heart reasons. During the year, participants will have in-person visits every 3 months and will also get follow-up phone calls.

Who can participate:
People with known or suspected CAD may be able to participate if they:

  • Have at least 1 medium-level narrowing (about 50–70%) in a heart artery seen on a CCTA scan
  • Have had an invasive blood flow test in the heart artery (FFR)

Study timeline and visits:
Participation lasts 1 year. Participants will be visited every 3 months and will also have follow-up phone calls during the year.

Updated on 21 May 2025. Study ID: 1403.414

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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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