Coronary Artery DiseaseDECIPHERNCT07548554
DECisive Intracoronary PHysiology and Imaging in the Evaluation and Reclassification of Non-culprit Lesions in Acute Coronary Syndrome
An observational study of Coronary Artery Disease and Acute Coronary Syndromes (ACS), run by Istanbul Mehmet Akif Ersoy Educational and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Despite all advances in diagnostic and therapeutic methods over the past century, ischemic heart disease (IHD) remains a leading cause of mortality and morbidity worldwide. IHD develops as a result of reversible or irreversible impairment of myocardial perfusion in acute or chronic settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndromes (ACS), Optic Coherence Tomography
- What is being tested?
- Intracoronary Physiology and Intracoronary imaging
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2026to 30 Apr 2027
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients presented with acute coronary syndrome undergoing successful PCI for the culprit vessel and at least one additional non-culprit vessel were enrolled form the Mehmet Akif Ersoy Hospital Emergency Department
Who may be able to join
- Presenting to the clinic with a diagnosis of Acute Coronary Syndrome.
- Having a significant (total or subtotal) culprit lesion detected during the index angiography procedure and having successfully undergone percutaneous coronary intervention (PCI) for this lesion.
- Having at least one distant non-culprit lesion with moderate stenosis (between 50% and 90%) according to visual angiographic evaluation in coronary arteries (or side branches with a diameter >2.5 mm) that are not major epicardial and not major left main coronary arteries.
- Having TIMI III flow in the vessel containing the non-culprit lesion to be evaluated.
- The patient being able to understand the nature of the study and signing the written informed consent form.
- Patients for whom intracoronary hemodynamic evaluation is planned for treatment planning of the non-culprit lesion after the index procedure.
Who cannot join
- Clinical Exclusion Criteria:
- Advanced renal insufficiency to the extent that the patient cannot tolerate the additional contrast load required for intracoronary imaging (IC-OCT) (e.g., eGFR < 30 mL/min/1.73 m²).
- Known serious allergy or absolute contraindication to the hyperemic agents to be used (e.g., adenosine, papaverine), iodinated contrast agents, or mandatory antiplatelet/anticoagulant therapy.
- Patients presenting to the hospital due to heart failure and cardiogenic shock.
- Additional investigation required due to in-stent restenosis of a non-culprit vessel.
- Patients with blood disorders, bleeding disorders, cancer, end-stage liver or kidney failure, patients with active bleeding, and pregnant women.
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- Angiographic and Procedural Exclusion Criteria:
- Presence of significant stenosis in the left main coronary artery (LMCA) or the patient having previously undergone coronary artery bypass graft (CABG) surgery.
- Failure of PCI on the culprit lesion in the index procedure, no-reflow, etc. The vessel containing the non-culprit lesion has technical impediments that prevent safe passage of the IC-OCT catheter or pressure/flow wire (e.g., excessive tortuosity, advanced angulation, very dense calcification, or chronic total occlusion [CTO]).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Mehmet Akif Ersoy Training and Research Hospital
Istanbul
About this study
Official title: DECisive Intracoronary PHysiology and Imaging in the Evaluation and Reclassification of Non-culprit Lesions in Acute Coronary Syndrome (DECIPHER-NonCulprit)
Despite all advances in diagnostic and therapeutic methods over the past century, ischemic heart disease (IHD) remains a leading cause of mortality and morbidity worldwide. IHD develops as a result of reversible or irreversible impairment of myocardial perfusion in acute or chronic settings. This perfusion abnormality most commonly arises from compromise of epicardial coronary artery patency due to stenosis, occlusion, or vasomotor abnormalities. Structural and/or functional alterations in the microcirculation may also contribute to impaired myocardial perfusion.
Conditions in which myocardial perfusion is acutely compromised are classified as acute coronary syndromes (ACS), whereas reversible ischemia developing on a chronic basis is evaluated under the umbrella of chronic coronary syndromes (CCS). In the assessment of epicardial (macrovascular) or microvascular pathologies leading to ischemia in CCS, angiography, a macroscopic lumenographic method, is often insufficient. Intracoronary pressure and flow measurements are required to determine the impact of angiographically detected epicardial lesions on coronary blood flow, perfusion pressure, and consequently myocardial perfusion. These measurements are referred to as invasive intracoronary physiology (IIP).
Read more
Current guidelines recommend that decisions regarding revascularization of intermediate epicardial lesions should be based on IIP. Revascularization guided by IIP is associated with reduced mortality and morbidity, along with a lower stent burden. IIP can be performed using pressure-based, flow-based, or combined strategies. Recent multinational studies indicate that strategies integrating both flow and pressure parameters achieve better clinical outcomes with fewer interventions and reduced stent implantation compared to pressure-only approaches. Indeed, in cases where coronary flow and flow reserve are preserved, abnormalities in pressure parameters alone may not justify revascularization.
Nevertheless, lesions deemed not to be associated with reversible ischemia based on IIP may still pose a risk due to plaque erosion/rupture and subsequent thrombotic cascades that can acutely compromise the lumen. Many acute coronary syndromes arise from lesions that are hemodynamically insignificant (i.e., do not affect flow) and unrelated to reversible ischemia in the CCS setting, but which undergo sudden near-total or total occlusion.
The histopathological characteristics of any coronary lesion can be evaluated using intracoronary imaging techniques. Intracoronary Optical Coherence Tomography (IC-OCT) is a high-resolution, real-time imaging modality that quantitatively assesses lipid-rich plaque content, evaluates the thickness and stability of the fibrous cap separating this content from the lumen, and provides detailed information regarding minimal lumen area, lesion morphology, surface characteristics, presence of erosion, and plaque vulnerability to rupture. IC-OCT can identify lesions that are hemodynamically insignificant yet may benefit from revascularization and have the potential to cause ACS.
Combined evaluation using IC-OCT and IIP enables an integrated assessment of both the relationship with chronic reversible perfusion impairment and the risk of precipitating ACS for each lesion and coronary segment, thereby facilitating optimal revascularization strategies. Despite the available evidence and guideline recommendations in CCS, the use of IC-OCT and IIP in the context of ACS remains limited due to procedural challenges and variability in practical application. These methods are not routinely recommended in guidelines and, in some cases, are even discouraged.
However, the optimal strategy for revascularization of non-culprit lesions in ACS remains uncertain, and no consensus has yet been established. Patients with ACS are at increased risk for recurrent events arising from all coronary lesions. Therefore, accurate evaluation and preventive revascularization strategies for these lesions are expected to provide substantial benefit. Our study aims to reclassify and characterize non-culprit lesions in patients with ACS using combined IC-OCT and IIP assessment.
- Conditions
- Coronary Artery Disease, Acute Coronary Syndromes (ACS), Optic Coherence Tomography, Fractional Flow Reserve
- Being tested
- Intracoronary Physiology, Intracoronary imaging
- Keywords
- coronary artery disease, acute coronary syndrome
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary PhysiologyDiagnostic test
The evaluation of non-culprit lesion with the intra-coronary physiology
Intracoronary imagingDiagnostic test
The evaluation of non-culprit lesion with the intra-coronary imaging (OCT)
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of non-culprit lesion by intracoronary physiology and imaging
The primary endpoint of our study is the evaluation of non-culprit lesions in patients with acute coronary syndrome using intracoronary physiology and imaging. We will determine how many of these non-culprit lesions have hemodynamic significance based on intracoronary physiology. Additionally, intravascular optical coherence tomography will be used to examine how many of these lesions exhibit vulnerable plaque characteristics.
Intracoronary Physiology Measurements:
- Fractional Flow Reserve (FFR): An FFR value of 0.80 will be considered hemodynamically significant epicardial ischemia
- Coronary Flow Reserve (CFR): CFR values < 2.0 will be considered impaired hyperemic coronary flow reserve.
Intracoronary Optical Coherence Tomography (OCT) Measurements:
- Plaque Characterization and Vulnerability Criteria:
- Thin-capsulated fibroatheroma (fibrous cap thickness < 65 µm)
- Lipid-rich core (lipid arc > 90°) and at its thinnest point
- Minimal lumen area less than 4.0 mm2
Measured: From enrollment to the end of the evaluation of non-culprit lesion within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start14 Apr 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Serkan Kahraman, Istanbul Mehmet Akif Ersoy Educational and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548554
- Sponsor's protocol ID
- DECIPHER-NonCulprit
- Acronym
- DECIPHER
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DECisive Intracoronary PHysiology and Imaging in the Evaluation and Reclassification of Non-culprit Lesions in Acute Coronary Syndrome (DECIPHER-NonCulprit)
- ClinicalTrials.gov ID
- NCT07548554
- Acronym / sponsor ID
- DECIPHER / DECIPHER-NonCulprit
- Conditions
- Coronary Artery Disease, Acute Coronary Syndromes (ACS), Optic Coherence Tomography, Fractional Flow Reserve
- Keywords
- coronary artery disease, acute coronary syndrome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training HospitalOther government
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 23 Apr 2026 (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.
Despite all advances in diagnostic and therapeutic methods over the past century, ischemic heart disease (IHD) remains a leading cause of mortality and morbidity worldwide. IHD develops as a result of reversible or irreversible impairment of myocardial perfusion in acute or chronic settings. This perfusion abnormality most commonly arises from compromise of epicardial coronary artery patency due to stenosis, occlusion, or vasomotor abnormalities. Structural and/or functional alterations in the microcirculation may also contribute to impaired myocardial perfusion.
Conditions in which myocardial perfusion is acutely compromised are classified as acute coronary syndromes (ACS), whereas reversible ischemia developing on a chronic basis is evaluated under the umbrella of chronic coronary syndromes (CCS). In the assessment of epicardial (macrovascular) or microvascular pathologies leading to ischemia in CCS, angiography, a macroscopic lumenographic method, is often insufficient. Intracoronary pressure and flow measurements are required to determine the impact of angiographically detected epicardial lesions on coronary blood flow, perfusion pressure, and consequently myocardial perfusion. These measurements are referred to as invasive intracoronary physiology (IIP).
Current guidelines recommend that decisions regarding revascularization of intermediate epicardial lesions should be based on IIP. Revascularization guided by IIP is associated with reduced mortality and morbidity, along with a lower stent burden. IIP can be performed using pressure-based, flow-based, or combined strategies. Recent multinational studies indicate that strategies integrating both flow and pressure parameters achieve better clinical outcomes with fewer interventions and reduced stent implantation compared to pressure-only approaches. Indeed, in cases where coronary flow and flow reserve are preserved, abnormalities in pressure parameters alone may not justify revascularization.
Nevertheless, lesions deemed not to be associated with reversible ischemia based on IIP may still pose a risk due to plaque erosion/rupture and subsequent thrombotic cascades that can acutely compromise the lumen. Many acute coronary syndromes arise from lesions that are hemodynamically insignificant (i.e., do not affect flow) and unrelated to reversible ischemia in the CCS setting, but which undergo sudden near-total or total occlusion.
The histopathological characteristics of any coronary lesion can be evaluated using intracoronary imaging techniques. Intracoronary Optical Coherence Tomography (IC-OCT) is a high-resolution, real-time imaging modality that quantitatively assesses lipid-rich plaque content, evaluates the thickness and stability of the fibrous cap separating this content from the lumen, and provides detailed information regarding minimal lumen area, lesion morphology, surface characteristics, presence of erosion, and plaque vulnerability to rupture. IC-OCT can identify lesions that are hemodynamically insignificant yet may benefit from revascularization and have the potential to cause ACS.
Combined evaluation using IC-OCT and IIP enables an integrated assessment of both the relationship with chronic reversible perfusion impairment and the risk of precipitating ACS for each lesion and coronary segment, thereby facilitating optimal revascularization strategies. Despite the available evidence and guideline recommendations in CCS, the use of IC-OCT and IIP in the context of ACS remains limited due to procedural challenges and variability in practical application. These methods are not routinely recommended in guidelines and, in some cases, are even discouraged.
However, the optimal strategy for revascularization of non-culprit lesions in ACS remains uncertain, and no consensus has yet been established. Patients with ACS are at increased risk for recurrent events arising from all coronary lesions. Therefore, accurate evaluation and preventive revascularization strategies for these lesions are expected to provide substantial benefit. Our study aims to reclassify and characterize non-culprit lesions in patients with ACS using combined IC-OCT and IIP assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presented with acute coronary syndrome undergoing successful PCI for the culprit vessel and at least one additional non-culprit vessel were enrolled form the Mehmet Akif Ersoy Hospital Emergency Department
Key inclusion criteria (6 listed)
- Presenting to the clinic with a diagnosis of Acute Coronary Syndrome.
- Having a significant (total or subtotal) culprit lesion detected during the index angiography procedure and having successfully undergone percutaneous coronary intervention (PCI) for this lesion.
- Having at least one distant non-culprit lesion with moderate stenosis (between 50% and 90%) according to visual angiographic evaluation in coronary arteries (or side branches with a diameter >2.5 mm) that are not major epicardial and not major left main coronary arteries.
- Having TIMI III flow in the vessel containing the non-culprit lesion to be evaluated.
- The patient being able to understand the nature of the study and signing the written informed consent form.
Key exclusion criteria (9 listed)
- Advanced renal insufficiency to the extent that the patient cannot tolerate the additional contrast load required for intracoronary imaging (IC-OCT) (e.g., eGFR < 30 mL/min/1.73 m²).
- Known serious allergy or absolute contraindication to the hyperemic agents to be used (e.g., adenosine, papaverine), iodinated contrast agents, or mandatory antiplatelet/anticoagulant therapy.
- Patients presenting to the hospital due to heart failure and cardiogenic shock.
- Additional investigation required due to in-stent restenosis of a non-culprit vessel.
- Patients with blood disorders, bleeding disorders, cancer, end-stage liver or kidney failure, patients with active bleeding, and pregnant women.
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 |
|---|---|---|
| Intracoronary PhysiologyThe evaluation of non-culprit lesion with the intra-coronary physiology | Diagnostic test | – |
| Intracoronary imagingThe evaluation of non-culprit lesion with the intra-coronary imaging (OCT) | Diagnostic test | – |
Primary outcome
Evaluation of non-culprit lesion by intracoronary physiology and imaging
Time frame: From enrollment to the end of the evaluation of non-culprit lesion within 4 weeks
The primary endpoint of our study is the evaluation of non-culprit lesions in patients with acute coronary syndrome using intracoronary physiology and imaging. We will determine how many of these non-culprit lesions have hemodynamic significance based on intracoronary physiology. Additionally, intravascular optical coherence tomography will be used to examine how many of these lesions exhibit vulnerable plaque characteristics. Intracoronary Physiology Measurements: * Fractional Flow Reserve (FFR): An FFR value of 0.80 will be considered hemodynamically significant epicardial ischemia * Coronary Flow Reserve (CFR): CFR values < 2.0 will be considered impaired hyperemic coronary flow reserve. Intracoronary Optical Coherence Tomography (OCT) Measurements: • Plaque Characterization and Vulnerability Criteria: 1. Thin-capsulated fibroatheroma (fibrous cap thickness < 65 µm) 2. Lipid-rich core (lipid arc > 90°) and at its thinnest point 3. Minimal lumen area less than 4.0 mm2
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 23 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Acute Coronary Syndromes (ACS), run by Istanbul Mehmet Akif Ersoy Educational and Training Hospital 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 9 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 23 Apr 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?
Evaluation of non-culprit lesion by intracoronary physiology and imaging (time frame: From enrollment to the end of the evaluation of non-culprit lesion within 4 weeks). 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 23 Apr 2026.