CTFFR and Prediction of Non-Significant CAD Lesions Draft

Study of Heart Artery Narrowing Using CT Scans and Pressure Testing

Enrolling By Invitation
20 years - 80 years
All
Phase N/A
250 participants needed
1 Location

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 how well CT-based measurements of blood flow in the heart arteries can help predict outcomes in people with known or suspected coronary artery disease (CAD) who have a moderate narrowing in at least 1 heart artery.

Participants will have had a heart CT scan (coronary computed tomography angiography, also called CCTA) and an invasive heart artery test (invasive coronary angiography) that includes a pressure measurement called fractional flow reserve (FFR). The study team will collect health and heart-related information from an existing patient registry, such as medical history and CT scan details about the artery narrowing. Participants will be followed for 1 year to see if they have major heart-related problems (also called major adverse cardiovascular events), such as heart-related death, acute coronary syndrome, unexpected procedures to restore blood flow, or hospitalization for heart reasons. During the 1-year follow-up, participants will have visits every 3 months and will also be followed by phone calls.

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

  • Have at least 1 moderate heart artery narrowing seen on a heart CT scan (CCTA)
  • Have also had FFR pressure testing of the heart arteries

Study timeline and visits:
Participation lasts 1 year. Participants will be visited every 3 months and followed up with phone calls during the year.

Updated on 16 May 2025. Study ID: 1403.414
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting referrals by invitation only