Coronary Artery DiseasePPPNCT05424705
Prediction of Atherosclerotic Plaque Progression
An observational study of Coronary Artery Disease, run by Na Homolce Hospital at 1 site in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- OCT, NIRS
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Jan 2015to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute coronary syndrome indicated for coronary angiography with presence of a non-culprit lesion not indicated for revascularization
Who may be able to join
- Acute coronary syndrome diagnosis
- Presence of at least one non-culprit coronary lesion (not indicated for revascularisation)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- OCT, NIRS
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT, NIRSDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Two years from the date of cardiac catheterization
Secondary outcomes (2)
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: 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.
Measured: Analyzed once at the time of cardiac catheterization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start15 Jan 2015
- Primary completion29 Jan 2018
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Na Homolce Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Czech Republic
- Responsible party
- Principal investigator, Karel Kopriva, Na Homolce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424705
- Sponsor's protocol ID
- 140504
- Acronym
- PPP
- Status last verified
- Jun 2022
- First submitted
- 16 May 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Atherosclerotic Plaque Progression in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05424705
- Acronym / sponsor ID
- PPP / 140504
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Na Homolce HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, Czech Republic
- Study start
- 15 Jan 2015 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute coronary syndrome indicated for coronary angiography with presence of a non-culprit lesion not indicated for revascularization
Key inclusion criteria (2 listed)
- Acute coronary syndrome diagnosis
- Presence of at least one non-culprit coronary lesion (not indicated for revascularisation)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT, NIRS | Diagnostic test | – |
Primary outcome
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)
2 secondary outcomes
Detection of vulnerable coronary atherosclerotic plaques by NIRS and OCT
Time frame: Measured once at the time of cardiac catheterization.
Presence of gene polymorphisms
Time frame: Analyzed once at the time of cardiac catheterization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Na Homolce Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of coronary atherosclerosis progression (time frame: Two years from the date of cardiac catheterization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.