Coronary DiseaseNCT01444599
VH-IVUS Plaque Composition Analysis By Fractional Flow Reserve
An observational study of Coronary Disease, run by Inje University at 4 sites in South Korea.
Trial summary
Recent clinical trials demonstrated that virtual histology-intravascular ultrasound (VH-IVUS) is a useful test predicting clinical outcomes of the coronary artery disease (CAD). Thin cap fibroatheroma (VH-TCFA) was proposed a predictor of cardiovascular event by VH-IVUS combined with more than 70% plaque burden and… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Coronary Disease
- How many people
- 100 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Mar 2010to Dec 2014
- 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: Patients who underwent coronary angiography for the diagnostic purposes because of clinical angina pectoris. Patient who underwent simultaneous virtual histology-intravascular ultrasound (VH-IVUS)and fractional flow reserve (FFR) measurement at the time of coronary angiography would be enrolled consecutively.
Who may be able to join
- clinical angina pectoris who underwent VH-IVUS and FFR during coronary angiography.
- agree with informed consent
Who cannot join
- unable to get informed consent
- low left ventricular ejection fraction less than 35%
- chronic renal failure (Cr>2.0mg/dl)
- acute myocardial infarction related coronary artery
- allergy to adenosine injection
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Keimyung University Dongsan Medical Center
Daegu
Inje University Ilsan Paik Hospital
Goyang, Gyeonggido, 411-709
Seoul National University Hospital
Seoul, Seoul
Ulsan University Hospital
Ulsan
About this study
Official title: Virtual Histology (VH)-Intravascular Ultrasound (IVUS) Tissue Characteristics Analysis of the Intermediate Coronary Artery Stenosis Lesion Predicting Physiologic Myocardial Ischemia by Myocardial Fraction Flow Reserve (FFR)
Recent clinical trials demonstrated that virtual histology-intravascular ultrasound (VH-IVUS) is a useful test predicting clinical outcomes of the coronary artery disease (CAD). Thin cap fibroatheroma (VH-TCFA) was proposed a predictor of cardiovascular event by VH-IVUS combined with more than 70% plaque burden and less than 4mm² minimal lumen area (MLA) by IVUS. Fractional flow reserve (FFR) is an established index of the physiological significance of a coronary stenosis. Recent large scale trials demonstrated FFR guided PCI showed favorable clinical outcomes. VH-IVUS represents anatomical severity, but FFR represents functional severity of CAD. Few studies reported relevance between two tests. Aim of this study was to investigate whether the geometry and composition of lesions were different under FFR criteria.
- Conditions
- Coronary Disease
- Keywords
- coronary atherosclerosis, virtual histology intravascular ultrasound, fractional flow reserve
- Medical subject headings
- Coronary Disease, 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 |
|---|---|---|
| low FFR group (<0.8) | the patient with FFR values less than 0.8 | |
| high FFR group (>0.8) | the patient with FFR values greater than 0.8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences VH-IVUS plaque composition between different FFR groups
VH-IVUS tissue composition (necrotic core, dense calicium, fibrotic, fibrofatty %) and atheroma type will be compared according to different FFR groups at the time of measurement procedure.
Measured: baseline
Secondary outcomes (2)
Serial physiologic and plaque composition changes of deferred lesions at 1 year FFR and VH-IVUS follow-up.
Approximately 60-70 of 100 enrolled patients would be deferred according to FFR values. Patient who provide consent for clinical and angiographic follow-up at one year would be assessed by physiologic FFR and VH-IVUS derived plaque composition. Relationship of serial physiologic and plaque composition changes will be evaluated. Anatomic and physiologic parameters associated with plaque progression and/or regression will be determined.
Measured: one year
Serial physiologic and plaque composition changes of stented lesions at 1 year FFR and VH-IVUS follow-up.
Approximately 30-40 of 100 enrolled patients would be stented according to FFR values. Patient who provide consent for clinical and angiographic follow-up at one year would be assessed by physiologic FFR and VH-IVUS derived plaque composition including stented segment. Relationship of serial physiologic and plaque composition changes will be evaluated. Anatomic and physiologic parameters associated with stent failure will be determined.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startMar 2010
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital
- Responsible party
- Principal investigator, Joon Hyung Doh, Inje University
- Investigators
- Joon Hyung Doh, MDPhD, Principal investigator, Inje University Ilsan Paik Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444599
- Sponsor's protocol ID
- IB-1110-048
- Status last verified
- Mar 2015
- First submitted
- 26 Sep 2011
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brugaletta S, Garcia-Garcia HM, Shen ZJ, Gomez-Lara J, Diletti R, Sarno G, Gonzalo N, Wijns W, de Bruyne B, Alfonso F, Serruys PW. Morphology of coronary artery lesions assessed by virtual histology intravascular ultrasound tissue characterization and fractional flow reserve. Int J Cardiovasc Imaging. 2012 Feb;28(2):221-8. doi: 10.1007/s10554-011-9816-3. Epub 2011 Feb 19.
PubMed 21336551Kubo T, Maehara A, Mintz GS, Doi H, Tsujita K, Choi SY, Katoh O, Nasu K, Koenig A, Pieper M, Rogers JH, Wijns W, Bose D, Margolis MP, Moses JW, Stone GW, Leon MB. The dynamic nature of coronary artery lesion morphology assessed by serial virtual histology intravascular ultrasound tissue characterization. J Am Coll Cardiol. 2010 Apr 13;55(15):1590-7. doi: 10.1016/j.jacc.2009.07.078.
PubMed 20378076Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358.
PubMed 21247313
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Histology (VH)-Intravascular Ultrasound (IVUS) Tissue Characteristics Analysis of the Intermediate Coronary Artery Stenosis Lesion Predicting Physiologic Myocardial Ischemia by Myocardial Fraction Flow Reserve (FFR)
- ClinicalTrials.gov ID
- NCT01444599
- Acronym / sponsor ID
- IB-1110-048
- Conditions
- Coronary Disease
- Keywords
- coronary atherosclerosis, virtual histology intravascular ultrasound, fractional flow reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Collaborators
- Seoul National University Hospital
- Study start
- Mar 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Oct 2011 (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.
Recent clinical trials demonstrated that virtual histology-intravascular ultrasound (VH-IVUS) is a useful test predicting clinical outcomes of the coronary artery disease (CAD). Thin cap fibroatheroma (VH-TCFA) was proposed a predictor of cardiovascular event by VH-IVUS combined with more than 70% plaque burden and less than 4mm² minimal lumen area (MLA) by IVUS. Fractional flow reserve (FFR) is an established index of the physiological significance of a coronary stenosis. Recent large scale trials demonstrated FFR guided PCI showed favorable clinical outcomes. VH-IVUS represents anatomical severity, but FFR represents functional severity of CAD. Few studies reported relevance between two tests. Aim of this study was to investigate whether the geometry and composition of lesions were different under FFR criteria.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low FFR group (<0.8) | – | –the patient with FFR values less than 0.8 |
| high FFR group (>0.8) | – | –the patient with FFR values greater than 0.8 |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent coronary angiography for the diagnostic purposes because of clinical angina pectoris. Patient who underwent simultaneous virtual histology-intravascular ultrasound (VH-IVUS)and fractional flow reserve (FFR) measurement at the time of coronary angiography would be enrolled consecutively.
Key inclusion criteria (2 listed)
- clinical angina pectoris who underwent VH-IVUS and FFR during coronary angiography.
- agree with informed consent
Key exclusion criteria (5 listed)
- unable to get informed consent
- low left ventricular ejection fraction less than 35%
- chronic renal failure (Cr>2.0mg/dl)
- acute myocardial infarction related coronary artery
- allergy to adenosine injection
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
Differences VH-IVUS plaque composition between different FFR groups
Time frame: baseline
VH-IVUS tissue composition (necrotic core, dense calicium, fibrotic, fibrofatty %) and atheroma type will be compared according to different FFR groups at the time of measurement procedure.
2 secondary outcomes
Serial physiologic and plaque composition changes of deferred lesions at 1 year FFR and VH-IVUS follow-up.
Time frame: one year
Serial physiologic and plaque composition changes of stented lesions at 1 year FFR and VH-IVUS follow-up.
Time frame: one 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 24 Mar 2015.
- Background: PubMed 21336551Brugaletta S, Garcia-Garcia HM, Shen ZJ, Gomez-Lara J, Diletti R, Sarno G, Gonzalo N, Wijns W, de Bruyne B, Alfonso F, Serruys PW. Morphology of coronary artery lesions assessed by virtual histology intravascular ultrasound tissue characterization and fractional flow reserve. Int J Cardiovasc Imaging. 2012 Feb;28(2):221-8. doi: 10.1007/s10554-011-9816-3. Epub 2011 Feb 19.
- Background: PubMed 20378076Kubo T, Maehara A, Mintz GS, Doi H, Tsujita K, Choi SY, Katoh O, Nasu K, Koenig A, Pieper M, Rogers JH, Wijns W, Bose D, Margolis MP, Moses JW, Stone GW, Leon MB. The dynamic nature of coronary artery lesion morphology assessed by serial virtual histology intravascular ultrasound tissue characterization. J Am Coll Cardiol. 2010 Apr 13;55(15):1590-7. doi: 10.1016/j.jacc.2009.07.078.
- Background: PubMed 21247313Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358.
Related trials for Coronary Disease
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
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.
Joon Hyung Doh, MDPhD principal investigator
Inje University Ilsan Paik Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by Inje University at 4 sites in South Korea.
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: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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?
Differences VH-IVUS plaque composition between different FFR groups (time frame: baseline). 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 NCT01444599, which also lists 3 linked publications.
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 24 Mar 2015.