Prediction of Atherosclerotic Plaque Progression

Coronary Artery Disease Clinical Trial

— PPP  

Official title:

Prediction of Atherosclerotic Plaque Progression in Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05424705
• Other study ID #: 140504
• Status: Active, not recruiting
• Start date: January 15, 2015
• Est. completion date: March 31, 2027

Study information

• Verified date: June 2022
• Source: Na Homolce Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: March 31, 2027
• Est. primary completion date: January 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Plaque, Atherosclerotic

Intervention

Diagnostic Test:
• OCT, NIRS

Locations

Country	Name	City	State
Czechia	Na Homolce Hospital	Prague

Sponsors (2)

Lead Sponsor	Collaborator
Na Homolce Hospital	Ministry of Health, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.