Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
All Genders
ID06979427

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)

Led by Shiraz University of Medical Sciences · Updated on 2025-05-21

250

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates the use of a diagnostic test called fractional flow reserve derived from CT angiography (NIFFR) in patients with known or suspected chronic coronary syndrome (CAD). It focuses on patients who have at least one coronary artery lesion with 50-70% narrowing. The study aims to see if NIFFR can identify lesions that are not significant and predict major heart-related events over a one-year period. Participants had coronary computed tomography angiography (CCTA) and invasive coronary angiography (ICA) with FFR measurements. The study included 250 patients with intermediate coronary lesions and NIFFR values above 0.80. Their coronary artery lesions were carefully measured and classified using advanced imaging software. The study groups compared patients with nonsignificant NIFFR and those with significant NIFFR values. Over one year, patients were followed closely, with visits every three months and phone calls to monitor for major adverse cardiovascular events (MACE), including heart-related death, acute coronary syndrome, unexpected procedures to restore blood flow, and hospitalizations due to heart problems. Researchers collected detailed patient information including heart function, lesion characteristics, and cardiovascular risk factors. Outcomes such as MACE, bleeding, and shortness of breath were tracked to evaluate the diagnostic value of NIFFR in predicting heart health risks.

CONDITIONS

Brief Title

CTFFR and Prediction of Non-Significant CAD Lesions

Who Can Participate

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with at least one intermediate coronary lesion (50-70% diameter narrowing) seen on coronary computed tomography angiography (CCTA)
  • Patients who underwent fractional flow reserve (FFR) testing
  • Adults aged between 20 and 80 years
Not Eligible

You will not qualify if you...

  • History of coronary artery bypass graft surgery (CABG)
  • Previous percutaneous coronary intervention (PCI) in the target vessel
  • Significant kidney impairment with estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m²
  • Allergy to contrast agents used in imaging
  • Poor image quality preventing proper CCTA or CT-FFR analysis

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 week

Participants undergo coronary computed tomography angiography (CCTA) and fractional flow reserve (FFR) testing to evaluate coronary artery lesions.

1 to 2 visits (in-person)

Long-term Monitoring

Duration - 1 year

Participants are clinically monitored for one year to assess major cardiovascular events and other health outcomes.

Quarterly visits and phone follow-ups every 3 months

Trial Site Locations

Total: 1 location

1

Professor Kojuri Cardiology Clinic

Shiraz, Fars, Iran, 55318

Actively Recruiting

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Research Team

J

javad UOM kojuri

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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