Chronic Coronary SyndromeNCT06979427
CTFFR and Prediction of Non-Significant CAD Lesions
A study testing NIFFR in people with Chronic Coronary Syndrome, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Coronary Syndrome
- What is being tested?
- NIFFR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2024to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site, 1 recruiting
- Recruiting
Professor Kojuri Cardiology Clinic
Shiraz, Fars, 55318
javad kojuri, MD.MS, 09171115083, kojurij@yahoo.com
javad kojuri, MD.MS., 09171115083, kojurij@yahoo.com
About this study
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)
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
Read the 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.
- Conditions
- Chronic Coronary Syndrome
- Being tested
- NIFFR
- Keywords
- Chronic Coronary Syndrome, Major adverse coronary events (MACE), fractional flow reserve, coronary CT angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIFFRDiagnostic test
Also called Non invasive fractional flow reserve
Fractional flow reserve derived from CT angiography from lesion between 50-70%
| Study group | Role | What they receive |
|---|---|---|
| nonsignificant NIFFR | Experimental | patients with coronary artery lesion in CT angiography, with NIFFR of more than 0.8 Receives: Diagnostic Test: NIFFR |
| significant NIFFR | Active comparator | patients with coronary artery lesion in CT angiography, with NIFFR of more than 0.8 Receives: Diagnostic Test: NIFFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Number of patients with bleeding
Number of patients with major or minor bleeding based on BARC classification
Measured: 1 year
Secondary outcomes (1)
Number of patients with dyspnoea
Number of patients with minor and major dyspnoea ( based on that it affect daily activity or tolerable or not)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2025
- Study start1 Jan 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- NIFFR of coronary less than 0.8
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979427
- Sponsor's protocol ID
- 1403.414
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data sharing by rational request
Publications
Khalafinezhad H, Zarifkar H, Vafa RG, Zarifkar H, Mirrhosseini A, Kojuri J. 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). BMC Cardiovasc Disord. 2026 Mar 26;26(1):393. doi: 10.1186/s12872-026-05782-0.
PubMed 41888687
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06979427
- Acronym / sponsor ID
- 1403.414
- Conditions
- Chronic Coronary Syndrome
- Keywords
- Chronic Coronary Syndrome, Major adverse coronary events (MACE), fractional flow reserve, coronary CT angiography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 19 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- NIFFR of coronary less than 0.8
| Arm | Type | Receives |
|---|---|---|
| nonsignificant NIFFR | Experimental | Diagnostic Test: NIFFRpatients with coronary artery lesion in CT angiography, with NIFFR of more than 0.8 |
| significant NIFFR | Active comparator | Diagnostic Test: NIFFRpatients with coronary artery lesion in CT angiography, with NIFFR of more than 0.8 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIFFRAlso: Non invasive fractional flow reserveFractional flow reserve derived from CT angiography from lesion between 50-70% | Diagnostic test | nonsignificant NIFFR, significant NIFFR |
Primary outcome
Number of patients with MACE
Time frame: 1 year
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
Number of patients with bleeding
Time frame: 1 year
Number of patients with major or minor bleeding based on BARC classification
1 secondary outcome
Number of patients with dyspnoea
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Derived from this study: PubMed 41888687Khalafinezhad H, Zarifkar H, Vafa RG, Zarifkar H, Mirrhosseini A, Kojuri J. 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). BMC Cardiovasc Disord. 2026 Mar 26;26(1):393. doi: 10.1186/s12872-026-05782-0.
- Individual participant dataSharing planned: No. data sharing by rational request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIFFR in people with Chronic Coronary Syndrome, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact javad UOM kojuri (09171115083, kojurij@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with MACE (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06979427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.