Multislice CT Angiography of Coronary Bifurcations and Outcomes After Intervention

NCT01943643 | Completed

• 1 other identifier: ZEM - CARD - 001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is prospective, observational study, that will be conducted in two high-volume university interventional cardiology centers. Study population consists of patients with "true" coronary bifurcations (Medina 1.0.1; 0.1.1; 1.1.1) with \>50% stenosis in both main (MB) and side branch (SB). Patients are scheduled to undergo percutaneous coronary intervention (PCI) based on clinical findings. Before PCI, patients will undergo multislice CT angiography (MSCTA). MSCTA before PCI for "true" non left main bifurcation lesions can determine atherosclerotic plaque characteristics in MB and SB and predict significant narrowing of SB after provisional stenting. Primary goal is to determine which plaque characteristics of "true" non left main bifurcation lesions in MB and SB, as assessed by MSCTA, can affect the occurrence of SB ostial compromise after provisional stenting. Patients will be seen in the office visit at 1, 3, 6 and 12 months after the procedure. Clinical evaluation and 12-channel ECG are mandatory at each visit. Comprehensive echocardiogram with 2D-strain analysis will be done at 3-month visit. Repeated coronary angiography will be done at 6-month visit, and will include quantitative analysis of previously treated bifurcation lesion.

Conditions

Coronary Artery Disease

Keywords

angiography, bifurcation, stenting, CT

Outcome Measures

Primary Outcomes (1)

• which atherosclerotic plaque characteristics of "true" non left main bifurcation lesions as assessed by MSCTA, can affect the occurrence of side branch ostial compromise after provisional stenting

  one year

Secondary Outcomes (1)

• To determine whether MSCTA correctly identifies the degree of stenosis and atherosclerotic plaque composition in MB and SB of bifurcation lesions compared to invasive quantitative coronary angiography and IVUS

  one year

Other Outcomes (1)

• correlation between endothelial wall shear stress, computed using mathematical model of fluid dynamic reconstruction of MSCTA findings, and the degree of stenosis and atherosclerotic plaque composition in bifurcation lesion

  one year

Study Arms (1)

CT angiography, coronary bifurcations

EXPERIMENTAL

Procedure: multislice CT angiography

Interventions

multislice CT angiography PROCEDURE

Study patients will undergo MSCTA on Toshiba Aquilion CXL 128 slice CT scanner using predefined protocol. The procedure will include calcium scoring (Agatston) then CT angiography using Ultravist 370 contrast agent ((iopromide concentration 370 mg/ml, Bayer Health Care, Germany). MSCTA angiograms will be analyzed using dedicated software Vital Vitrea Advanced 6.2, Vital Images, Minnetonka, Minnesota, US. The bifurcation lesion analyses will include: the measurement of the angle between MB and SB, measurement of the lesion length, reference diameter of the vessel, degree of stenosis, atherosclerotic plaque analysis 10 mm proximal and distal in the MB, and 5 mm from the ostium of the SB, and at the level of maximum stenosis (minimal lumen diameter).

CT angiography, coronary bifurcations

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has signed the informed consent form prior to entering the study
• Patient has stable angina pectoris, silent ischemia, or proven coronary ischemia on functional testing.
• Patient does not have a medical condition that can be a contraindication for MSCTA and/or PCI, i. e. inability to hold breath for 15 sec, atrial fibrillation and uncontrolled heart rate.
• Patient does not have an allergy to aspirin, clopidogrel or contrast agent.
• Patient does not have active peptic ulcer.
• Patient has "true" bifurcation lesion detected on diagnostic coronary angiogram. "True" bifurcation lesion is defined as significant stenoses of both MB and SB (Medina class 1.0.1; 0.1.1; 1.1.1).
• SB must have diameter greater than 2 mm to be adequately visualized on MSCTA.
• Patient does not have heavy calcifications at the site of bifurcation planned to be treated, based on MSCTA findings (circumferential calcification greater than 180°, and in length of 5 mm or more at the site of bifurcation)
• Patient does not suffer from renal failure with estimated creatinine clearance less than 30 ml/min. Patients with creatinine clearance between 30-60 ml/min must be adequately hydrated before MSCTA and PCI.

You may not qualify if:

• Patient does suffer from manifest heart failure, and does have LVEF \<30%.
• The bifurcation lesion planned to be treated in the study is within the culprit artery causing myocardial infarction, and/or it has been grafted surgically or treated by PCI procedure before entering the study.
• Patient has an allergy to aspirin, clopidogrel or contrast agent.
• Patient has active peptic ulcer.

Sponsors & Collaborators

• Clinical Hospital Center Zemun: lead

Study Sites (1)

Clinical Hospital Center Zemun

Belgrade, 11080, Serbia

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Aleksandar N Neskovic, MD PhD

  Clinical Hospital Center Zemun

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Ivan Ilic

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 17, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: June 2, 2023

Record last verified: 2023-06

Locations

SE (1)