Coronary Artery DiseaseNCT02131935
Impaired Peripheral Endothelial Function and In-stent Restenosis
An observational study of Coronary Artery Disease, run by Kumamoto University at 1 site in Japan.
Trial summary
The investigators assessed the hypothesis that whether RH-PAT index (RHI) as a marker of endothelial dysfunction could predict occurrence of ISR after percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 513 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2010to May 2014
- How long will I take part?
- 1 Year
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patient sampling This is a prospective observational study of all consecutive patients with coronary artery disease (CAD) treated with PCI at Kumamoto University Hospital between January 2010 and September 2012. Inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant CAD.
Who may be able to join
- Inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant CAD.
Who cannot join
- Exclusion criteria were balloon angioplasty only without stent deployment, death during hospitalization, and patients who had comorbidities affected RH-PAT results such as hemodialysis, advanced cancer, after surgery of breast cancer, dementia, collagen disease, and not performing RH-PAT with uncertain reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impaired Peripheral Endothelial Function as Assessed by Digital Reactive Hyperemia Peripheral Arterial Tonometry and Risk of In-Stent Restenosis
The investigators assessed the hypothesis that whether RH-PAT index (RHI) as a marker of endothelial dysfunction could predict occurrence of ISR after percutaneous coronary intervention (PCI).
Read the detailed description
This is a prospective observational study of all consecutive patients with coronary artery disease (CAD) treated with PCI at Kumamoto University Hospital between January 2010 and September 2012. Inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant CAD.
- Conditions
- Coronary Artery Disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| ISR Group | Patients Group Experienced In-Stent Restenosis (ISR) | |
| Non-ISR | Patients Group Without in-stent restenosis (ISR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of in-stent restenosis
Based on the Japanese clinical routine, follow-up (F/U) angiography will be performed at six and nine months after PCI with bare-metal stent (BMS) and drug-eluting stent (DES), respectively. ISR was defined as percent diameter stenosis >50% at F/U angiography assessed by quantitative coronary angiography.
Measured: within 1 year
Secondary outcomes (1)
Endothelial Function
Fingertip reactive hyperemia peripheral arterial tonometry (RH-PAT) is a new device that provides noninvasive, automatic, and quantitative evaluation of endothelial dysfunction with low intra- and inter-observer variability. We assess the hypothesis that whether RH-PAT index (RHI) as a marker of endothelial dysfunction could predict occurrence of ISR after percutaneous coronary intervention (PCI). RHI will be measured using Endo-PAT2000 (Itamar Medical, Caesarea, Israel) before PCI (initial RHI) and at follow-up angiography (F/U RHI) in consecutive patients who had successful PCI in de novo coronary lesions.
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startJan 2010
- Primary completionSep 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 513 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kumamoto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenichi Tsujita, MD, PhD, Kumamoto University
- Investigators
- Hisao Ogawa, MD, PhD, Study chair, Kumamoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131935
- Sponsor's protocol ID
- 1120
- Status last verified
- May 2014
- First submitted
- 1 May 2014
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Komura N, Tsujita K, Yamanaga K, Sakamoto K, Kaikita K, Hokimoto S, Iwashita S, Miyazaki T, Akasaka T, Arima Y, Yamamoto E, Izumiya Y, Yamamuro M, Kojima S, Tayama S, Sugiyama S, Matsui K, Nakamura S, Hibi K, Kimura K, Umemura S, Ogawa H. Impaired Peripheral Endothelial Function Assessed by Digital Reactive Hyperemia Peripheral Arterial Tonometry and Risk of In-Stent Restenosis. J Am Heart Assoc. 2016 Jun 17;5(6):e003202. doi: 10.1161/JAHA.116.003202.
PubMed 27317348
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired Peripheral Endothelial Function as Assessed by Digital Reactive Hyperemia Peripheral Arterial Tonometry and Risk of In-Stent Restenosis
- ClinicalTrials.gov ID
- NCT02131935
- Acronym / sponsor ID
- 1120
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Kumamoto UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 May 2014 (estimated)
- 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 investigators assessed the hypothesis that whether RH-PAT index (RHI) as a marker of endothelial dysfunction could predict occurrence of ISR after percutaneous coronary intervention (PCI).
Detailed description
This is a prospective observational study of all consecutive patients with coronary artery disease (CAD) treated with PCI at Kumamoto University Hospital between January 2010 and September 2012. Inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant CAD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISR Group | – | –Patients Group Experienced In-Stent Restenosis (ISR) |
| Non-ISR | – | –Patients Group Without in-stent restenosis (ISR) |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patient sampling This is a prospective observational study of all consecutive patients with coronary artery disease (CAD) treated with PCI at Kumamoto University Hospital between January 2010 and September 2012. Inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant CAD.
Key inclusion criteria (1 listed)
- Inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant CAD.
Key exclusion criteria (1 listed)
- Exclusion criteria were balloon angioplasty only without stent deployment, death during hospitalization, and patients who had comorbidities affected RH-PAT results such as hemodialysis, advanced cancer, after surgery of breast cancer, dementia, collagen disease, and not performing RH-PAT with uncertain reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence or absence of in-stent restenosis
Time frame: within 1 year
Based on the Japanese clinical routine, follow-up (F/U) angiography will be performed at six and nine months after PCI with bare-metal stent (BMS) and drug-eluting stent (DES), respectively. ISR was defined as percent diameter stenosis >50% at F/U angiography assessed by quantitative coronary angiography.
1 secondary outcome
Endothelial Function
Time frame: within 1 year
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 28 May 2014.
- Derived from this study: PubMed 27317348Komura N, Tsujita K, Yamanaga K, Sakamoto K, Kaikita K, Hokimoto S, Iwashita S, Miyazaki T, Akasaka T, Arima Y, Yamamoto E, Izumiya Y, Yamamuro M, Kojima S, Tayama S, Sugiyama S, Matsui K, Nakamura S, Hibi K, Kimura K, Umemura S, Ogawa H. Impaired Peripheral Endothelial Function Assessed by Digital Reactive Hyperemia Peripheral Arterial Tonometry and Risk of In-Stent Restenosis. J Am Heart Assoc. 2016 Jun 17;5(6):e003202. doi: 10.1161/JAHA.116.003202.
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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.
Hisao Ogawa, MD, PhD study chair
Kumamoto University
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 Kumamoto 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 1 inclusion and 1 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 28 May 2014. 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?
Presence or absence of in-stent restenosis (time frame: within 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02131935, which also lists 1 linked publication.
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 28 May 2014.