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Computed Tomography Coronary Angiography Before Stent Implantation

Primary Purpose

Stable Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
PCI on the basis of coronary angiography
CT guided PCI
Sponsored by
National Institute of Cardiology, Warsaw, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stable Coronary Artery Disease focused on measuring Computed coronary angiography, Stent implantation, IVUS

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stable coronary artery disease
  • Planned stent implantation into single lesion in native coronary artery
  • Planned stent diameter: 2.5-4.0 mm

Exclusion Criteria:

  • Women younger than 50 years
  • Lesion location in left main coronary artery
  • Atrial fibrilation or other significant arrythmia
  • Severe chronic obturatory pulmonary disease
  • Hyperthyroidism
  • Known allergy to contrast media
  • Glomerular filtration rate < 30
  • Treatment of bifurcation lesion
  • Stent implantation for in-stent restenosis

Sites / Locations

  • Institute of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CT

Angio

Arm Description

Procedure of stent implantation will be planed on the basis of both angiography and computed tomography results.

Procedure of stent implantation will be planned only on the basis of diagnostic coronary angiography.

Outcomes

Primary Outcome Measures

Minimal in stent lumen area as assessed by IVUS
Adequacy of lesion coverage defined as minimal lumen area in reference segments adjacent to stent shoulder.

Secondary Outcome Measures

Mean stent lumen area
Mean lumen area and plaque and media area in 10mm segments adjucent to stent edges.
Qualitative and quantitative assessment of potential complications (tissue prolaps, plaque shift, stent edge dissection and stent malapossition)

Full Information

First Posted
June 25, 2010
Last Updated
July 4, 2011
Sponsor
National Institute of Cardiology, Warsaw, Poland
Collaborators
Ministerstwo Nauki i Szkolnictwa Wyższego, Warszawa, Polska
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1. Study Identification

Unique Protocol Identification Number
NCT01205425
Brief Title
Computed Tomography Coronary Angiography Before Stent Implantation
Official Title
Role of Computed Tomography Coronary Angiography in Optimalization of Percutaneous Coronary Interventions With Stent Implantation.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Cardiology, Warsaw, Poland
Collaborators
Ministerstwo Nauki i Szkolnictwa Wyższego, Warszawa, Polska

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to determine whether results of the computed tomography coronary angiography may be helpful in planning and performing percutaneous angioplasty in patients with stable angina pectoris.
Detailed Description
Currently most percutaneous coronary interventions (PCI) are planned and performed on the basis of invasive coronary angiography which provides the information that is confined to the vessel lumen. This limitation may be partially responsible for the unfavorable long term outcome and complications that occur in some patients. Additional information on the disease burden in angiographically normal coronary segments adjacent to the lesion site could impact the treatment strategy and clinical results. Imaging modalities that allow not only lumen but also vessel wall assessment include both invasive (e.g. intravascular ultrasounds - IVUS) and non-invasive (e.g. multislice computed tomography - MSCT) methods. IVUS guidance of the coronary interventions is expensive and given its invasiveness is related to the additional risk. The number of patients who are referred for coronary angiography with significant stenosis diagnosed with MSCT is rapidly increasing. Most interventional cardiologists are not familiar with coronary vessel images produced by MSCT. The aim of our study is to assess if the analyses of MSCT images before the PCI may impact the treatment strategy and immediate results. The study will enroll subjects with significant coronary stenosis diagnosed with MSCT who are referred to the catheterisation laboratory for invasive angiography and PCI. The study participants will be randomized into two groups: Group 1 - the results of MSCT are analysed by the interventional cardiologist that is to perform angiography and PCI. Based on this analysis preliminary procedural strategy is planned (stent diameters, decision on direct stenting vs. predilatation, decision on postdilation) Group 2 - interventional cardiologist is blinded to the images obtained by MSCT. The PCI procedure is performed solely on the basis of invasive coronary angiography In both study groups IVUS will be performed before and after stent implantation. The operator will be blinded to the results of pre-PCI IVUS. The second IVUS will be performed when angiographic results are optimal in the opinion of the operator. The results of the second IVUS examination will be the efficacy measure of the two compared treatment strategies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Coronary Artery Disease
Keywords
Computed coronary angiography, Stent implantation, IVUS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT
Arm Type
Experimental
Arm Description
Procedure of stent implantation will be planed on the basis of both angiography and computed tomography results.
Arm Title
Angio
Arm Type
Active Comparator
Arm Description
Procedure of stent implantation will be planned only on the basis of diagnostic coronary angiography.
Intervention Type
Other
Intervention Name(s)
PCI on the basis of coronary angiography
Intervention Description
Interventional cardiologist will be blinded to the images obtained by CT. The PCI procedure will be planned and performed solely on the basis of invasive coronary angiography
Intervention Type
Procedure
Intervention Name(s)
CT guided PCI
Intervention Description
The results of the CT scan will be analysed by the interventional cardiologist that is to perform angiography and PCI. Based on this analysis preliminary procedural strategy is planned (stent diameters, decision on direct stenting vs. predilatation, decision on postdilation)
Primary Outcome Measure Information:
Title
Minimal in stent lumen area as assessed by IVUS
Time Frame
Up to 10 minutes after stent implantation
Title
Adequacy of lesion coverage defined as minimal lumen area in reference segments adjacent to stent shoulder.
Time Frame
Up to 10 minutes after stent implantation
Secondary Outcome Measure Information:
Title
Mean stent lumen area
Time Frame
Up to 10 minutes after stent implantation
Title
Mean lumen area and plaque and media area in 10mm segments adjucent to stent edges.
Time Frame
Up to 10 minutes after stent implantation
Title
Qualitative and quantitative assessment of potential complications (tissue prolaps, plaque shift, stent edge dissection and stent malapossition)
Time Frame
Up to 10 minutes after stent implantation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable coronary artery disease Planned stent implantation into single lesion in native coronary artery Planned stent diameter: 2.5-4.0 mm Exclusion Criteria: Women younger than 50 years Lesion location in left main coronary artery Atrial fibrilation or other significant arrythmia Severe chronic obturatory pulmonary disease Hyperthyroidism Known allergy to contrast media Glomerular filtration rate < 30 Treatment of bifurcation lesion Stent implantation for in-stent restenosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerzy Pregowski, MD
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Cardiology
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland

12. IPD Sharing Statement

Links:
URL
http://www.ikard.pl
Description
Web page of Institute of Cardiology, Warsaw

Learn more about this trial

Computed Tomography Coronary Angiography Before Stent Implantation

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