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Imaging Collagen Content in Human Coronary Atherosclerosis and Assessing its Role in Plaque Progression and Destabilization: A Clinical OCT-polarimetry Study

Imaging Collagen Content in Human Coronary Atherosclerosis and Assessing its Role in Plaque Progression and Destabilization: A Clinical OCT-polarimetry Study - Intravascular OCT-polarimetry Registry

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000046910
Enrollment
600
Registered
2022-05-01
Start date
2022-05-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Patients with coronary artery disease

Interventions

None listed

Sponsors

Osaka City University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. scheduled to undergo coronary interventional treatment or OCT imaging at Osaka City University Hospital between April 2022 and March 2026 2. chronic coronary syndrome or acute coronary syndrome diagnosed by noninvasive coronary imaging or invasive coronary angiography 3. between 20 and 90 years of age at the time of initial consent.

Exclusion criteria

Exclusion criteria: 1. patients diagnosed by physician as hemodynamically unstable at the time of enrollment 2. patients who cannot undergo coronary angiography or intracoronary imaging due to allergy to contrast media 3. patients with severe renal failure (eGFR less than 30ml/min/1.73mm2) who are not on maintenance dialysis 4. patients with a life expectancy of less than 1 year 5. pregnant women Patients who are judged unsuitable for participation in this study by the principal investigator or sub-investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
The polarization characteristics (birefringence and degree of polarization resolution) of coronary artery lesions that develop ACS will be analyzed and compared with those of lesions in patients with CCS to identify determinants of ACS development (in patients who develop ACS due to in-stent restenosis or stent thrombosis, the polarization characteristics will be compared with those of in-stent neointima in patients with CCS).

Secondary

MeasureTime frame
1) Comparison of biomarkers (high-sensitivity CRP, high-sensitivity cardiac troponin I, CK-MB, IL-1beta, IL-6, MCP-1, MMP-2, MMP-9, MMP-13, adipokine) and polarization characteristics of coronary lesions 2) Evaluation of polarization characteristics of coronary lesions and acute response to stent therapy (stent expansion, stent-induced coronary dissection, slow-flow phenomenon, no-reflow phenomenon) 3) Coronary artery calcification angle, length, thickness, and polarization characteristics in relation to acute phase response to balloon dilation 4) Evaluation of chronic restenosis and predictors of chronic restenosis to treatment with drug-eluting balloons 5) Evaluation of stent restenosis and predictors by coronary CT or coronary angiography in the chronic phase 6) Progression of stenosis in non-responsible lesions by coronary CT or coronary angiography in chronic phase, evaluation of predictors 7) Comparison of peri-coronary adipose tissue attenuation index by coronary CT and polarization characteristics of coronary lesions 8) Comparison of coronary plaque volume and polarization characteristics by coronary CT 9) Comparison of lipid index and coronary plaque polarization characteristics by NIRS-IVUS 10) Comparison with coronary ischemia assessment (FFR, myocardial scintigraphy) 11) Combined events (all-cause mortality, cardiovascular death, myocardial infarction, unstable or stable angina requiring revascularization, stroke, transient ischemia, PCI / CABG, stent thrombosis and restenosis)

Countries

Japan

Contacts

Public ContactKenichiro Otsuka

Osaka City University Graduate School of Medicine Cardiovascular Medicine

otsukakenichiro1@gmail.com06-6645-3801

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026