Comparison Between Main Branch and Side Branch Vessels

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Seoul National University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Bon-Kwon Koo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01046409
First received: January 8, 2010
Last updated: August 18, 2011
Last verified: August 2011
  Purpose

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

Condition Intervention
Coronary Artery Disease
Other: Measuring collateral flow

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Comparison of Clinical, Electrical and Physiologic Significance Between Main Branch and Side Branch Vessels

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • ST elevation during 1min balloon occlusion [ Time Frame: Day 1 after PCI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain score during 1min balloon occlusion [ Time Frame: Day 1 after PCI ] [ Designated as safety issue: No ]
  • coronary wedge pressure [ Time Frame: during the procedure ] [ Designated as safety issue: No ]
  • Usefulness of new scoring system [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    New scoring system includes the vessel size, myocardial territory and relationship with neighboring branches


Estimated Enrollment: 51
Study Start Date: January 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Main vessel, side branch vessel Other: Measuring collateral flow
Measuring collateral flow using pressure and/or velocity coronary wire

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with significant coronary artery disease, involving the bifurcation lesions

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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%
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046409

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bon-Kwon Koo, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01046409     History of Changes
Other Study ID Numbers: H-0910-003-062
Study First Received: January 8, 2010
Last Updated: August 18, 2011
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Seoul National University Hospital:
Coronary artery disease
Bifurcation
Myocardial infarction
Myocardial ischemia
Collateral

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014