Coronary Artery Disease ProgressionNCT03540381
Relation Among HDL Functionality, Neoatherosclerosis and Target Lesion Revascularization
An observational study of Coronary Artery Disease Progression, run by Kobe University at 1 site in Japan.
Trial summary
The aim of this study is to evaluate the relation among cholesterol uptake capacity which measure HDL functionality, neoathrosclerosis and target-lesion revascularization. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Coronary Artery Disease Progression
- What is being tested?
- neoatherosclerosis
- How many people
- 181 participants
- Where
- 1 siteJapan
- Study dates
- 1 May 2011to 31 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study population consist of the consecutive patients who have undergone coronary-artery OCT. the investigators performed OCT for these reasons: (1) planned follow-up coronary angiography and OCT as routine stent follow-up or due to other study protocols, regardless of symptoms; (2) evidence of myocardial ischemia, such as silent myocardial ischemia, stable angina, or acute coronary syndrome; or (3) planned follow-up angiography for other stent segments. Exclusion criteria for OCT were (1) anatomically unsuitable target artery for OCT, according to previously described criteria; (2) apparent congestive heart failure; (3) renal insufficiency with baseline creatinine level of ≥2.0 mg/dL except for under hemodialysis; or (4) no written informed consent from the patient.
Who may be able to join
- Clinical diagnosis of coronary artery disease
- Patients who had undergone percutaneous coronary intervention
- Patients who had been treated with bare-metal stents, drug-eluting stents
- Patients who had successfully undergone follow-up OCT for the target stents >6 months after stenting.
Who cannot join
- The stent was implanted in the left main trunk
- OCT images were of insufficient quality
Trial locations and contacts
1 site in 1 country.
Japan1 site
Kobe University Graduate School of Medicine, Department of Cardiology
Kobe, Hyōgo, 650-0017
About this study
Official title: Relation Among Cholesterol Uptake Capacity Which Measure HDL Functionality, Neoatherosclerosis and Target Lesion Revascularization After Stent Implantation
The aim of this study is to evaluate the relation among cholesterol uptake capacity which measure HDL functionality, neoathrosclerosis and target-lesion revascularization.
Read the detailed description
Intracoronary stent implantation has markedly reduced the incidence of restenosis in patients with coronary artery disease. However, in-stent restenosis requiring target-lesion revascularization (TLR) occurs even with the use of drug-eluting stents. Emerging evidence suggests that among various potential risk factors, atherogenic progression within the neointima, "neoatherosclerosis" is one of the major contributors to TLR, and that patients' lipid profile is one of the key risk factors for the development of neoatherosclerosis.
Conversely, recent animal and human studies have demonstrated the importance of high-density lipoprotein (HDL) functionality, rather than of HDL-cholesterol levels, in the development of de novo coronary artery disease. Cholesterol efflux capacity, a measure of the ability of HDL to promote cholesterol removal from lipid-laden macrophages, was found to be inversely correlated with the incidence of cardiovascular events and was shown to improve cardiovascular risk prediction beyond that with the use of traditional coronary risk factors. Therefore, the investigators hypothesized that the HDL function of promoting cholesterol removal from lipid-laden macrophages could be associated with TLR through its effect on the process of neoatherosclerosis progression within stents.
Recently, the investigators developed a rapid cell-free assay system to directly evaluate the capacity of HDL to accept additional cholesterol; the measurement of this cholesterol uptake capacity (CUC) enables HDL functionality to be readily evaluated in our daily practice. Thus, the investigators performed this study in order to clarify the potential relationship among CUC, neoatherosclerosis, and TLR by using the novel cell-free assay system, CUC measurement, and optical coherence tomography (OCT) analysis.
- Conditions
- Coronary Artery Disease Progression
- Being tested
- neoatherosclerosis
- Keywords
- Neoatherosclerosis, Cholesterol Uptake Capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoatherosclerosisOther
| Study group | Role | What they receive |
|---|---|---|
| Identified neoatherosclerosis group | From the patients treated with coronary stents, the investigators functionally evaluated their HDL by measuring the CUC. the investigators also performed follow-up OCT to evaluate the presence of neoatherosclerosis. Consecutive patients were divided into two groups. The patients with neoatherosclerosis were identified neoatherosclerosis group and the remaining were not-identified neoatherosclerosis group. After that, clinical follow-up was performed to assess TLR and the investigators examined the relation between CUC, neoatherosclerosis and TLR. Receives: Other: neoatherosclerosis | |
| Not-identified neoatherosclerosis group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol Uptake Capacity (CUC)
CUC is a new rapid cell-free assay system to evaluate the functional capacity of HDL to accept additional cholesterol
Measured: an average of a year and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 May 2011
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease ProgressionStudies 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
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kobe University
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hiromasa Otake, Kobe University
- Investigators
- Hiromasa Otake, PhD, Study chair, Kobe University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540381
- Sponsor's protocol ID
- KobeU-152M816M
- Status last verified
- May 2018
- First submitted
- 15 May 2018
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Among Cholesterol Uptake Capacity Which Measure HDL Functionality, Neoatherosclerosis and Target Lesion Revascularization After Stent Implantation
- ClinicalTrials.gov ID
- NCT03540381
- Acronym / sponsor ID
- KobeU-152M816M
- Conditions
- Coronary Artery Disease Progression
- Keywords
- Neoatherosclerosis, Cholesterol Uptake Capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Kobe UniversityIndustry (pharma, biotech, devices)
- Study start
- 1 May 2011 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 30 May 2018 (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.
The aim of this study is to evaluate the relation among cholesterol uptake capacity which measure HDL functionality, neoathrosclerosis and target-lesion revascularization.
Detailed description
Intracoronary stent implantation has markedly reduced the incidence of restenosis in patients with coronary artery disease. However, in-stent restenosis requiring target-lesion revascularization (TLR) occurs even with the use of drug-eluting stents. Emerging evidence suggests that among various potential risk factors, atherogenic progression within the neointima, "neoatherosclerosis" is one of the major contributors to TLR, and that patients' lipid profile is one of the key risk factors for the development of neoatherosclerosis.
Conversely, recent animal and human studies have demonstrated the importance of high-density lipoprotein (HDL) functionality, rather than of HDL-cholesterol levels, in the development of de novo coronary artery disease. Cholesterol efflux capacity, a measure of the ability of HDL to promote cholesterol removal from lipid-laden macrophages, was found to be inversely correlated with the incidence of cardiovascular events and was shown to improve cardiovascular risk prediction beyond that with the use of traditional coronary risk factors. Therefore, the investigators hypothesized that the HDL function of promoting cholesterol removal from lipid-laden macrophages could be associated with TLR through its effect on the process of neoatherosclerosis progression within stents.
Recently, the investigators developed a rapid cell-free assay system to directly evaluate the capacity of HDL to accept additional cholesterol; the measurement of this cholesterol uptake capacity (CUC) enables HDL functionality to be readily evaluated in our daily practice. Thus, the investigators performed this study in order to clarify the potential relationship among CUC, neoatherosclerosis, and TLR by using the novel cell-free assay system, CUC measurement, and optical coherence tomography (OCT) analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Identified neoatherosclerosis group | – | Other: neoatherosclerosisFrom the patients treated with coronary stents, the investigators functionally evaluated their HDL by measuring the CUC. the investigators also performed follow-up OCT to evaluate the presence of neoatherosclerosis. Consecutive patients were divided into two groups. The patients with neoatherosclerosis were identified neoatherosclerosis group and the remaining were not-identified neoatherosclerosis group. After that, clinical follow-up was performed to assess TLR and the investigators examined the relation between CUC, neoatherosclerosis and TLR. |
| Not-identified neoatherosclerosis group | – | – |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study population consist of the consecutive patients who have undergone coronary-artery OCT. the investigators performed OCT for these reasons: (1) planned follow-up coronary angiography and OCT as routine stent follow-up or due to other study protocols, regardless of symptoms; (2) evidence of myocardial ischemia, such as silent myocardial ischemia, stable angina, or acute coronary syndrome; or (3) planned follow-up angiography for other stent segments. Exclusion criteria for OCT were (1) anatomically unsuitable target artery for OCT, according to previously described criteria; (2) apparent congestive heart failure; (3) renal insufficiency with baseline creatinine level of ≥2.0 mg/dL except for under hemodialysis; or (4) no written informed consent from the patient.
Key inclusion criteria (4 listed)
- Clinical diagnosis of coronary artery disease
- Patients who had undergone percutaneous coronary intervention
- Patients who had been treated with bare-metal stents, drug-eluting stents
- Patients who had successfully undergone follow-up OCT for the target stents >6 months after stenting.
Key exclusion criteria (2 listed)
- The stent was implanted in the left main trunk
- OCT images were of insufficient quality
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 |
|---|---|---|
| neoatherosclerosis | Other | Identified neoatherosclerosis group |
Primary outcome
Cholesterol Uptake Capacity (CUC)
Time frame: an average of a year and a half
CUC is a new rapid cell-free assay system to evaluate the functional capacity of HDL to accept additional cholesterol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- 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.
Hiromasa Otake, PhD study chair
Kobe University Graduate School of Medicine
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 Progression, run by Kobe University at 1 site in Japan.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 30 May 2018. 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cholesterol Uptake Capacity (CUC) (time frame: an average of a year and a half). 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 30 May 2018.