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DECisive Intracoronary PHysiology and Imaging in the Evaluation and Reclassification of Non-culprit Lesions in Acute Coronary Syndrome

DECisive Intracoronary PHysiology and Imaging in the Evaluation and Reclassification of Non-culprit Lesions in Acute Coronary Syndrome (DECIPHER-NonCulprit)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07548554
Acronym
DECIPHER
Enrollment
40
Registered
2026-04-23
Start date
2026-04-14
Completion date
2027-04-30
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Acute Coronary Syndromes (ACS), Optic Coherence Tomography, Fractional Flow Reserve

Keywords

coronary artery disease, acute coronary syndrome

Brief 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. 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.

Interventions

The evaluation of non-culprit lesion with the intra-coronary physiology

DIAGNOSTIC_TESTIntracoronary imaging

The evaluation of non-culprit lesion with the intra-coronary imaging (OCT)

Sponsors

Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

Clinical

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of non-culprit lesion by intracoronary physiology and imagingFrom enrollment to the end of the evaluation of non-culprit lesion within 4 weeksThe 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026