Prediction of Atherosclerotic Plaque Progression | NCT05424705

Studies
Prediction of Atherosclerotic Plaque Progression

NCT05424705

Sponsor

Na Homolce Hospital

Status

Active, not recruiting

Last Update Posted

Jun 21, 2022Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

OCT, NIRS

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2015Actual

Primary Completion Date

Jan 29, 2018Actual

Completion Date

Mar 31, 2027Estimated

First Submitted Date

May 16, 2022

First Submission Date that Met QC Criteria

Jun 15, 2022

First Posted Date

Jun 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2022

Last Update Posted Date

Jun 21, 2022Actual

Name	Class
Ministry of Health, Czech Republic	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Actual

Name	Type	Description	Arm Group Labels	Other Names
OCT, NIRS	Diagnostic Test

Outcomes Module

Primary Outcomes

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 Outcomes

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).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Na Homolce Hospital		Prague		15030	Czechia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D041623	Tomography, Optical Coherence
D019265	Spectroscopy, Near-Infrared

Ancestor Terms

ID	Term
D041622	Tomography, Optical
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Patient DNA will be isolated from peripheral blood leucocytes by standard techniques. Genetic analysis of polymorphisms in gene for Hemoxygenase-1 and endothelial Nitric Oxide Synthase.