Prediction of Atherosclerotic Plaque Progression (PPP)

Prediction of Atherosclerotic Plaque Progression in Patients With Acute Coronary Syndrome

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

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: OCT, NIRS

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 15030
    • Na Homolce Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute coronary syndrome indicated for coronary angiography with presence of a non-culprit lesion not indicated for revascularization

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of coronary atherosclerosis progression	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)	Two years from the date of cardiac catheterization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of vulnerable coronary atherosclerotic plaques by NIRS and OCT	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).	Measured once at the time of cardiac catheterization.
Presence of gene polymorphisms	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.	Analyzed once at the time of cardiac catheterization.

Collaborators and Investigators

• Sponsor: Na Homolce Hospital
• Collaborators: Ministry of Health, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2015
• Primary Completion (Actual): January 29, 2018
• Study Completion (Anticipated): March 31, 2027

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Coronary Disease; Coronary Artery Disease; Plaque, Atherosclerotic
• Other Study ID Numbers: 140504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No