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Active, Not Recruiting

NCT Number: NCT05424705

Prediction of Atherosclerotic Plaque Progression

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Na Homolce Hospital

Prague, 15030, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OCT, NIRS

Diagnostic Test

Primary outcomes

  1. Prediction of coronary atherosclerosis progression

    Time frame: Two years from the date of cardiac catheterization

    Prediction of coronary atherosclerosis progression (assesed by computed tomography, CT) in patients with acute coronary syndrome by the use of intracoronary imaging methods (OCT and NIRS)

Secondary outcomes

  1. Detection of vulnerable coronary atherosclerotic plaques by NIRS and OCT

    Time frame: Measured once at the time of cardiac catheterization.

    Subjects are presenting for their clinically-indicated cardiac catheterization and NIRS and OCT imaging are performed at the time of this catheterization).

    NIRS is used for the quantification of plaque lipid content using the 4mm region of the vessel with the highest lipid core burden index (LCBI) and thus, the highest lipid content (maxLCBI4mm). OCT is used for the measuring of the thickness of plaque fibrous cap and thus, the presence of thin-cap fibroatheroma (TCFA).

  2. Presence of gene polymorphisms

    Time frame: Analyzed once at the time of cardiac catheterization.

    Presence of gene polymorphisms in genes for Hemoxygenase-1 ane Endothelial Nitric Oxide Synthase by genetic analysis of patient DNA isolated from periferal blood leukocytes.

Sponsors and collaborators

Lead sponsor

Na Homolce Hospital

Other

Collaborators

  • Ministry of Health, Czech Republic

Registry information

Official study title

Prediction of Atherosclerotic Plaque Progression in Patients With Acute Coronary Syndrome

Acronym: PPP

Important dates

Study start
2015
Primary completion
2018
Study completion
2027
First posted
Jun 21, 2022
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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