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

April 21, 2026 updated by: Serkan Kahraman, Istanbul Mehmet Akif Ersoy Educational and Training Hospital

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).

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Istanbul Mehmet Akif Ersoy Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

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 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.

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]).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of the evaluation of non-culprit lesion within 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DECIPHER-NonCulprit

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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