Prediction of Atherosclerotic Plaque Progression

NCT ID: NCT05424705

Last Updated: 2022-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-15

Study Completion Date

2027-03-31

Brief Summary

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To predict coronary atherosclerosis progression in patients with acute coronary syndrome by the use of intracoronary imaging methods.

To investigate the ability of NIRS to detect vulnerable plaque characterized by the presence of OCT-defined TCFA To study the influence of gene polymorphisms (in genes playing role in vessel dilatation) on the progression of coronary atherosclerosis and clinical outcomes

Detailed Description

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The fundamental aim of this study is to investigate the ability of intracoronary imaging to predict progression of coronary atherosclerosis in patients with acute coronary syndrome. In patients who are indicated for acute coronary angiography and have at least one non-culprit lesion (not indicated for revascularization) identical segment of non-culprit vessel will be analysed and several parameters will be detected by OCT (optical coherence tomography) and NIRS (near-infrared spectroscopy) including the presence of TCFA (thin-cap fibroatheroma) and plaque lipid content quantified by LCBI (lipid core burden index). During follow up visits (1Y, 2Y, 5Y and 10Y) major cardiovascular events will be monitored and the progression of coronary involvement will be estimated at 1Y and 2Y by CCTA (coronary computed angiography).

The second part of the trial is to investigate the ability of NIRS to detect vulnerable plaque characterized by the presence of OCT-defined TCFA.

A further target is to study the influence of gene polymorphisms (in genes playing a role in vessel dilatation) on the progression of coronary atherosclerosis and clinical outcomes. Patient DNA will be isolated from peripheral blood leucocytes, and polymorphisms in genes for Hemoxygenase-1 and endothelial Nitric Oxide Synthase will be analysed.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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OCT, NIRS

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Acute coronary syndrome diagnosis
* Presence of at least one non-culprit coronary lesion (not indicated for revascularisation)

Exclusion Criteria

* Contraindication for OCT or IVUS
* Circulatory instability
* Renal insufficiency (creatinine level \>200umol/l)
* Pregnant or of childbirth age and not using reliable contraception
* Life expectancy of less than one year
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Czech Republic

OTHER_GOV

Sponsor Role collaborator

Na Homolce Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karel Kopriva

M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Na Homolce Hospital

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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140504

Identifier Type: -

Identifier Source: org_study_id

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