Comparison Between Main Branch and Side Branch Vessels

An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

The purpose of this trial is 1. to compare the clinical significance of the main vessel and the side branch vessel using EKG, pain score and coronary wedge pressure 2. to develop a new scoring system to predict the clinical significance of a side branch 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?: Measuring collateral flow
How many people: 51 participants
Where: 1 siteSouth Korea
Study dates: Jan 2010to Dec 2011
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with significant coronary artery disease, involving the bifurcation lesions

Who may be able to join

Age ≥ 18
Able to verbally confirm understandings of risks, benefits of receiving percutaneous coronary intervention (PCI) for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
Significant stenosis at bifurcation lesion (>50% by visual estimate) which always includes stenosis of side branch (true bifurcation)
Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) in a native coronary artery with diameter of ≥ 2.25 mm
Target lesion(s) amenable for PCI with final kissing balloon angioplasty for the side branch

Who cannot join

Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
Patients refuse to give informed consent
Patients with left main coronary artery stenosis
Patients with total occlusion of the bifurcation lesion
Patients with infarct-related artery at the lesion of interest
Patients with left ventricular ejection fraction<40%

Show all 9Show fewer

Patients with primary cardiomyopathy
Patients with chronic kidney disease defined as serum Cr>2.0
Patients who have severe side effects or contraindication to adenosine

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, 110-744

Other trials in South Korea

About this study

Official title: Comparison of Clinical, Electrical and Physiologic Significance Between Main Branch and Side Branch Vessels

The purpose of this trial is

to compare the clinical significance of the main vessel and the side branch vessel using EKG, pain score and coronary wedge pressure
to develop a new scoring system to predict the clinical significance of a side branch

Read the detailed description

Clinical significance EKG change, pain score during 1 min balloon occlusion
Different characteristics between ST segment elevation vs non-elevation side branches
Comparison of coronary wedge pressure
Establishing a new scoring system to predict the ST elevation during 1min balloon occlusion

Conditions: Coronary Artery Disease
Being tested: Measuring collateral flow
Keywords: Coronary artery disease, Bifurcation, Myocardial infarction, Myocardial ischemia, Collateral
Medical subject headings: Coronary Artery Disease, Myocardial Infarction, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Measuring collateral flowOther
Measuring collateral flow using pressure and/or velocity coronary wire

Study groups in NCT01046409
Study group	Role	What they receive
Main vessel, side branch vessel		Not described Receives: Other: Measuring collateral flow

What is being measured

The primary outcome is the main question the study is designed to answer.

ST elevation during 1min balloon occlusion
Measured: Day 1 after PCI

Secondary outcomes (3)

Pain score during 1min balloon occlusion
Measured: Day 1 after PCI
coronary wedge pressure
Measured: during the procedure
Usefulness of new scoring system
New scoring system includes the vessel size, myocardial territory and relationship with neighboring branches
Measured: During the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Dec 2011

First posted12 Jan 2010 (estimated)
Study startJan 2010
Primary completionDec 2011 (estimated)
Study completionDec 2011 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe sponsor's other registered studies.
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: 51 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01046409
Sponsor's protocol ID: H-0910-003-062
Status last verified: Aug 2011
First submitted: 8 Jan 2010
Last updated: 22 Aug 2011
Results posted: No
Data monitoring committee: No

Publications

Koo BK, Kang HJ, Youn TJ, Chae IH, Choi DJ, Kim HS, Sohn DW, Oh BH, Lee MM, Park YB, Choi YS, Tahk SJ. Physiologic assessment of jailed side branch lesions using fractional flow reserve. J Am Coll Cardiol. 2005 Aug 16;46(4):633-7. doi: 10.1016/j.jacc.2005.04.054.
PubMed 16098427
Pijls NH, van Son JA, Kirkeeide RL, De Bruyne B, Gould KL. Experimental basis of determining maximum coronary, myocardial, and collateral blood flow by pressure measurements for assessing functional stenosis severity before and after percutaneous transluminal coronary angioplasty. Circulation. 1993 Apr;87(4):1354-67. doi: 10.1161/01.cir.87.4.1354.
PubMed 8462157
Pijls NH, Bech GJ, el Gamal MI, Bonnier HJ, De Bruyne B, Van Gelder B, Michels HR, Koolen JJ. Quantification of recruitable coronary collateral blood flow in conscious humans and its potential to predict future ischemic events. J Am Coll Cardiol. 1995 Jun;25(7):1522-8. doi: 10.1016/0735-1097(95)00111-g.
PubMed 7759702
Billinger M, Kloos P, Eberli FR, Windecker S, Meier B, Seiler C. Physiologically assessed coronary collateral flow and adverse cardiac ischemic events: a follow-up study in 403 patients with coronary artery disease. J Am Coll Cardiol. 2002 Nov 6;40(9):1545-50. doi: 10.1016/s0735-1097(02)02378-1.
PubMed 12427404
Koo BK, Lee SP, Lee JH, Park KW, Suh JW, Cho YS, Chung WY, Doh JH, Nam CW, Yu CW, Lee BK, Vassilev D, Gil R, Lim HS, Tahk SJ, Kim HS. Assessment of clinical, electrocardiographic, and physiological relevance of diagonal branch in left anterior descending coronary artery bifurcation lesions. JACC Cardiovasc Interv. 2012 Nov;5(11):1126-32. doi: 10.1016/j.jcin.2012.05.018.
PubMed 23174636

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Clinical, Electrical and Physiologic Significance Between Main Branch and Side Branch Vessels
ClinicalTrials.gov ID: NCT01046409
Acronym / sponsor ID: H-0910-003-062
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease, Bifurcation, Myocardial infarction, Myocardial ischemia, Collateral
Study type: Observational
Recruitment status: Unknown status
Enrolment: 51 participants (estimated)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: Jan 2010
Primary completion: Dec 2011 (estimated)
Study completion: Dec 2011 (estimated)
First posted: 12 Jan 2010 (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 purpose of this trial is

to compare the clinical significance of the main vessel and the side branch vessel using EKG, pain score and coronary wedge pressure
to develop a new scoring system to predict the clinical significance of a side branch

Detailed description

Clinical significance EKG change, pain score during 1 min balloon occlusion
Different characteristics between ST segment elevation vs non-elevation side branches
Comparison of coronary wedge pressure
Establishing a new scoring system to predict the ST elevation during 1min balloon occlusion

Study design

Observational model: Case only
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Main vessel, side branch vessel	–	Other: Measuring collateral flow

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with significant coronary artery disease, involving the bifurcation lesions

Key inclusion criteria (5 listed)

Age ≥ 18
Able to verbally confirm understandings of risks, benefits of receiving percutaneous coronary intervention (PCI) for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
Significant stenosis at bifurcation lesion (>50% by visual estimate) which always includes stenosis of side branch (true bifurcation)
Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) in a native coronary artery with diameter of ≥ 2.25 mm
Target lesion(s) amenable for PCI with final kissing balloon angioplasty for the side branch

Key exclusion criteria (9 listed)

Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
Patients refuse to give informed consent
Patients with left main coronary artery stenosis
Patients with total occlusion of the bifurcation lesion
Patients with infarct-related artery at the lesion of interest

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
Measuring collateral flowMeasuring collateral flow using pressure and/or velocity coronary wire	Other	Main vessel, side branch vessel

Primary outcome

ST elevation during 1min balloon occlusion
Time frame: Day 1 after PCI

3 secondary outcomes

Pain score during 1min balloon occlusion
Time frame: Day 1 after PCI
coronary wedge pressure
Time frame: during the procedure
Usefulness of new scoring system
Time frame: During the procedure

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2011.
Background: PubMed 16098427Koo BK, Kang HJ, Youn TJ, Chae IH, Choi DJ, Kim HS, Sohn DW, Oh BH, Lee MM, Park YB, Choi YS, Tahk SJ. Physiologic assessment of jailed side branch lesions using fractional flow reserve. J Am Coll Cardiol. 2005 Aug 16;46(4):633-7. doi: 10.1016/j.jacc.2005.04.054.
Background: PubMed 8462157Pijls NH, van Son JA, Kirkeeide RL, De Bruyne B, Gould KL. Experimental basis of determining maximum coronary, myocardial, and collateral blood flow by pressure measurements for assessing functional stenosis severity before and after percutaneous transluminal coronary angioplasty. Circulation. 1993 Apr;87(4):1354-67. doi: 10.1161/01.cir.87.4.1354.
Background: PubMed 7759702Pijls NH, Bech GJ, el Gamal MI, Bonnier HJ, De Bruyne B, Van Gelder B, Michels HR, Koolen JJ. Quantification of recruitable coronary collateral blood flow in conscious humans and its potential to predict future ischemic events. J Am Coll Cardiol. 1995 Jun;25(7):1522-8. doi: 10.1016/0735-1097(95)00111-g.
Background: PubMed 12427404Billinger M, Kloos P, Eberli FR, Windecker S, Meier B, Seiler C. Physiologically assessed coronary collateral flow and adverse cardiac ischemic events: a follow-up study in 403 patients with coronary artery disease. J Am Coll Cardiol. 2002 Nov 6;40(9):1545-50. doi: 10.1016/s0735-1097(02)02378-1.
Derived from this study: PubMed 23174636Koo BK, Lee SP, Lee JH, Park KW, Suh JW, Cho YS, Chung WY, Doh JH, Nam CW, Yu CW, Lee BK, Vassilev D, Gil R, Lim HS, Tahk SJ, Kim HS. Assessment of clinical, electrocardiographic, and physiological relevance of diagonal branch in left anterior descending coronary artery bifurcation lesions. JACC Cardiovasc Interv. 2012 Nov;5(11):1126-32. doi: 10.1016/j.jcin.2012.05.018.

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ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
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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 Seoul National University Hospital at 1 site 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Aug 2011. 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 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?

Results are not available in the source record.

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?

ST elevation during 1min balloon occlusion (time frame: Day 1 after PCI). 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 NCT01046409, which also lists 5 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 22 Aug 2011.