Coronary Artery DiseaseNCT07051473
Relationship Between Coronary CT Angiography Findings and Prognosis Of Patients Undergoing PCI
An observational study of Coronary Artery Disease, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Researchers at Cerrahpaşa Medical School in Istanbul are studying how a heart imaging test called coronary CT angiography can help improve care for people with coronary artery disease. This disease happens when fatty buildups, known as plaques, form in the arteries that supply blood to the heart. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to Dec 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of individuals residing in the Republic of Turkey. The study sample was selected using a simple random sampling method and includes individuals from this population who presented to the Cardiology Department of Cerrahpaşa Medical Faculty with symptoms or findings suggestive of stable coronary artery disease. It is assumed that every citizen living within the borders of the Republic of Turkey has an equal probability of presenting to the clinic with complaints related to this condition.
Who may be able to join
- Be over 18 years of age.
- Have presented to the Cardiology Department of Cerrahpaşa Medical Faculty with symptoms or findings suggestive of stable coronary artery disease and undergone a coronary CT angiography based on clinical evaluation.
- In addition, meet at least one of the following conditions:
- The coronary CT angiography showed at least one lesion with at least one high-risk plaque feature, and based on the 2018 European Society of Cardiology (ESC) Guidelines on Myocardial Revascularisation and the presence of CAD-RADS 1 or 2 lesions, no revascularisation was performed.
- The coronary CT angiography revealed a CAD-RADS 3 or higher lesion without high-risk plaque features, and revascularisation was performed on the target lesion, in accordance with the 2018 European Society of Cardiology (ESC) Guidelines on Myocardial Revascularisation.
- The coronary CT angiography revealed a CAD-RADS 3 or higher lesion with high-risk plaque features, and revascularisation was performed on the target lesion, in accordance with the 2018 European Society of Cardiology (ESC) Guidelines on Myocardial Revascularisation.
Who cannot join
- Being underaged (below 18 years of age).
- Loss of medical follow-up data caused by discontinuation of participation in follow-up visits.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Prof. Dr. Murat Dilmener Hospital
Istanbul, Bakırköy, 34153
About this study
Official title: Impact of Coronary CT Angiography Findings on Prognosis of Patients Undergoing Percutaneous Coronary Intervention
Researchers at Cerrahpaşa Medical School in Istanbul are studying how a heart imaging test called coronary CT angiography can help improve care for people with coronary artery disease. This disease happens when fatty buildups, known as plaques, form in the arteries that supply blood to the heart. Over time, these plaques can limit blood flow and lead to serious problems like heart attacks. The goal of this research is to better understand which types of plaques may lead to worse outcomes, and how treatment choices-such as placing a stent or using medication-can affect a person's long-term heart health. This study will help doctors make better treatment decisions in the future. Some plaques are more dangerous than others, even when they don't cause major blockages. These are called high-risk or "vulnerable" plaques. Even though they may not narrow the artery much at first, they can still cause heart attacks in the future. Currently, doctors do not usually place stents in arteries unless the plaque causes a serious blockage. This is because stenting also carries risks, and it is not clear whether treating high-risk plaques early-before they cause problems-helps people live longer or feel better. This study hopes to find out whether certain types of plaques should be treated differently in the future. This study will include at least 789 adults who have already had coronary CT angiography as part of their regular care at Cerrahpaşa Medical School's cardiology clinic. These participants were treated either with a stent or with medication, depending on their medical needs. The decision to do the scan and how to treat the person was made by their doctor, following national and international medical guidelines. People who join the study do so voluntarily. They can choose to leave the study at any time without affecting their regular medical care. Participants will be followed for at least one year, starting from the day of their CT scan. They will return for check-ups at 3, 6, and 12 months. After the first year, they will continue to have yearly follow-up visits as part of routine care. At each visit, the study team will check symptoms, such as chest pain or shortness of breath; monitor health indicators, like cholesterol and blood sugar; and review any new heart procedures or treatments. Researchers will also review results from medical tests, such as blood tests, electrocardiograms (EKGs), heart ultrasounds (echocardiograms), repeat heart scans or procedures if done. If a participant has had a heart procedure done at another hospital, they will be asked to bring those records to their next appointment. This helps the research team get a full picture of each participant's heart health. The researchers will look at the features of the plaques seen in each participant's heart scan. They want to find out which types of plaques are more likely to lead to heart attacks or other serious problems. Participants will be divided into groups based on whether they received a stent or not. The researchers will compare outcomes between these groups to see if certain plaque types are more dangerous and whether stenting made a difference. The study will try to answer questions like: which plaque features are linked to future heart problems; do people with high-risk plaques do better with stents or with medication; can doctors use plaque features to decide who should get a stent? This research may help doctors better identify high-risk plaques and choose the right treatment for each person. The study does not involve any new, experimental, or unapproved treatments. All participants will receive medical care that follows well-established guidelines from groups like the European Society of Cardiology (ESC) and the American Heart Association (AHA). Participants are not asked to take new medications or undergo any tests or treatments that are not already part of their usual care. If new medical knowledge becomes available during the study that could affect treatment, participants will be informed and can choose whether to continue with the original plan or make changes. All personal and medical information will be kept confidential. The data will be stored securely in the hospital's system, and only the research team and authorised health officials will be allowed to access it. Participants' names and other identifying information will not appear in any published reports. If a participant wants to know their results or the overall results of the study, they can ask for a report. Even if someone leaves the study or stops coming to the clinic, the information already collected may still be used in the research unless the participant requests otherwise. There is no cost to participate in this study. The study will not affect your health insurance or create any additional charges. All medical care will continue to be covered by Turkey's national health system or your existing insurance.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Vulnerable plaque, Vulnerable patient, Vulnerable blood, High risk coronary plaques, PCI, Coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High risk plaque features positive, PCI positive | The people that has at least one lesion in their coronary arteries, carrying at least one high-risk plaque feature, derived from CCTA and treated with PCI of that lesion | |
| High risk plaque features positive, PCI negative | The people that has at least one lesion in their coronary arteries, carrying at least one high-risk plaque feature, derived from CCTA and not treated with PCI of that lesion | |
| High-risk plaque features negative, PCI positive | The people that has no lesion in their coronary arteries, carrying at least one high-risk plaque feature, derived from CCTA and treated with PCI of any lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause death
Death from any cause
Measured: Baseline, 3 months, 6 months, 12 months
Major adverse cardiovascular events
Composition of cardiac death, spontaneous myocardial infarction, target vessel myocardial infarction, target vessel revascularisation, target lesion revascularisation
Measured: Baseline, 3 months, 6 months, 12 months
Secondary outcomes (5)
Any myocardial infarction
Any event of myocardial infarction defined by the "Fourth Universal Definition Of Myocardial Infarction"
Measured: Baseline, 3 months, 6 months, 12 months
Any revascularisation procedure
Revascularisation by either percutaneous coronary intervention or coronary artery bypass grafting
Measured: Baseline, 3 months, 6 months, 12 months
Target vessel non-target lesion revascularisation
Any lesion or revascularisation of a lesion in the target vessel other than the target lesion, respectively
Measured: Baseline, 3 months, 6 months, 12 months
Non-target vessel revascularisation
Revascularisation of a vessel for which revascularisation is not attempted in the first place, or of one with no lesion with high-risk plaque characteristics.
Measured: Baseline, 3 months, 6 months, 12 months
Improvement in angina class as defined by the Canadian Cardiovascular Society (CCS)
Any improvement in the angina class of the Canadian Cardiovascular Society (CCS) from a higher class to a lower class
Measured: Baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alpin Mert TEKİN, Istanbul University - Cerrahpasa
- Investigators
- Barış İKİTİMUR, Study director, İstanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051473
- Sponsor's protocol ID
- 2025/66
- Status last verified
- Feb 2026
- First submitted
- 26 Jun 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Coronary CT Angiography Findings on Prognosis of Patients Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT07051473
- Acronym / sponsor ID
- 2025/66
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Vulnerable plaque, Vulnerable patient, Vulnerable blood, High risk coronary plaques, PCI, Coronary intervention
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Jul 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.
Researchers at Cerrahpaşa Medical School in Istanbul are studying how a heart imaging test called coronary CT angiography can help improve care for people with coronary artery disease. This disease happens when fatty buildups, known as plaques, form in the arteries that supply blood to the heart. Over time, these plaques can limit blood flow and lead to serious problems like heart attacks. The goal of this research is to better understand which types of plaques may lead to worse outcomes, and how treatment choices-such as placing a stent or using medication-can affect a person's long-term heart health. This study will help doctors make better treatment decisions in the future. Some plaques are more dangerous than others, even when they don't cause major blockages. These are called high-risk or "vulnerable" plaques. Even though they may not narrow the artery much at first, they can still cause heart attacks in the future. Currently, doctors do not usually place stents in arteries unless the plaque causes a serious blockage. This is because stenting also carries risks, and it is not clear whether treating high-risk plaques early-before they cause problems-helps people live longer or feel better. This study hopes to find out whether certain types of plaques should be treated differently in the future. This study will include at least 789 adults who have already had coronary CT angiography as part of their regular care at Cerrahpaşa Medical School's cardiology clinic. These participants were treated either with a stent or with medication, depending on their medical needs. The decision to do the scan and how to treat the person was made by their doctor, following national and international medical guidelines. People who join the study do so voluntarily. They can choose to leave the study at any time without affecting their regular medical care. Participants will be followed for at least one year, starting from the day of their CT scan. They will return for check-ups at 3, 6, and 12 months. After the first year, they will continue to have yearly follow-up visits as part of routine care. At each visit, the study team will check symptoms, such as chest pain or shortness of breath; monitor health indicators, like cholesterol and blood sugar; and review any new heart procedures or treatments. Researchers will also review results from medical tests, such as blood tests, electrocardiograms (EKGs), heart ultrasounds (echocardiograms), repeat heart scans or procedures if done. If a participant has had a heart procedure done at another hospital, they will be asked to bring those records to their next appointment. This helps the research team get a full picture of each participant's heart health. The researchers will look at the features of the plaques seen in each participant's heart scan. They want to find out which types of plaques are more likely to lead to heart attacks or other serious problems. Participants will be divided into groups based on whether they received a stent or not. The researchers will compare outcomes between these groups to see if certain plaque types are more dangerous and whether stenting made a difference. The study will try to answer questions like: which plaque features are linked to future heart problems; do people with high-risk plaques do better with stents or with medication; can doctors use plaque features to decide who should get a stent? This research may help doctors better identify high-risk plaques and choose the right treatment for each person. The study does not involve any new, experimental, or unapproved treatments. All participants will receive medical care that follows well-established guidelines from groups like the European Society of Cardiology (ESC) and the American Heart Association (AHA). Participants are not asked to take new medications or undergo any tests or treatments that are not already part of their usual care. If new medical knowledge becomes available during the study that could affect treatment, participants will be informed and can choose whether to continue with the original plan or make changes. All personal and medical information will be kept confidential. The data will be stored securely in the hospital's system, and only the research team and authorised health officials will be allowed to access it. Participants' names and other identifying information will not appear in any published reports. If a participant wants to know their results or the overall results of the study, they can ask for a report. Even if someone leaves the study or stops coming to the clinic, the information already collected may still be used in the research unless the participant requests otherwise. There is no cost to participate in this study. The study will not affect your health insurance or create any additional charges. All medical care will continue to be covered by Turkey's national health system or your existing insurance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High risk plaque features positive, PCI positive | – | –The people that has at least one lesion in their coronary arteries, carrying at least one high-risk plaque feature, derived from CCTA and treated with PCI of that lesion |
| High risk plaque features positive, PCI negative | – | –The people that has at least one lesion in their coronary arteries, carrying at least one high-risk plaque feature, derived from CCTA and not treated with PCI of that lesion |
| High-risk plaque features negative, PCI positive | – | –The people that has no lesion in their coronary arteries, carrying at least one high-risk plaque feature, derived from CCTA and treated with PCI of any lesion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of individuals residing in the Republic of Turkey. The study sample was selected using a simple random sampling method and includes individuals from this population who presented to the Cardiology Department of Cerrahpaşa Medical Faculty with symptoms or findings suggestive of stable coronary artery disease. It is assumed that every citizen living within the borders of the Republic of Turkey has an equal probability of presenting to the clinic with complaints related to this condition.
Key inclusion criteria (6 listed)
- Be over 18 years of age.
- Have presented to the Cardiology Department of Cerrahpaşa Medical Faculty with symptoms or findings suggestive of stable coronary artery disease and undergone a coronary CT angiography based on clinical evaluation.
- In addition, meet at least one of the following conditions:
Key exclusion criteria (2 listed)
- Being underaged (below 18 years of age).
- Loss of medical follow-up data caused by discontinuation of participation in follow-up visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause death
Time frame: Baseline, 3 months, 6 months, 12 months
Death from any cause
Major adverse cardiovascular events
Time frame: Baseline, 3 months, 6 months, 12 months
Composition of cardiac death, spontaneous myocardial infarction, target vessel myocardial infarction, target vessel revascularisation, target lesion revascularisation
5 secondary outcomes
Any myocardial infarction
Time frame: Baseline, 3 months, 6 months, 12 months
Any revascularisation procedure
Time frame: Baseline, 3 months, 6 months, 12 months
Target vessel non-target lesion revascularisation
Time frame: Baseline, 3 months, 6 months, 12 months
Non-target vessel revascularisation
Time frame: Baseline, 3 months, 6 months, 12 months
Improvement in angina class as defined by the Canadian Cardiovascular Society (CCS)
Time frame: Baseline, 3 months, 6 months, 12 months
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 25 Feb 2026.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial
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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. This study is not recruiting at the moment.
Barış İKİTİMUR study director
İstanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 6 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause death (time frame: Baseline, 3 months, 6 months, 12 months). 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?
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 25 Feb 2026.