Computed Tomography Coronary Angiography Before Stent Implantation

This study has been completed.
Sponsor:
Collaborator:
Ministerstwo Nauki i Szkolnictwa Wyższego, Warszawa, Polska
Information provided by:
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT01205425
First received: June 25, 2010
Last updated: July 4, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Stable Coronary Artery Disease
Other: PCI on the basis of coronary angiography
Procedure: CT guided PCI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Role of Computed Tomography Coronary Angiography in Optimalization of Percutaneous Coronary Interventions With Stent Implantation.

Resource links provided by NLM:


Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:
  • Minimal in stent lumen area as assessed by IVUS [ Time Frame: Up to 10 minutes after stent implantation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean stent lumen area [ Time Frame: Up to 10 minutes after stent implantation ] [ Designated as safety issue: No ]
  • Mean lumen area and plaque and media area in 10mm segments adjucent to stent edges. [ Time Frame: Up to 10 minutes after stent implantation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2009
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CT
Procedure of stent implantation will be planed on the basis of both angiography and computed tomography results.
Procedure: CT guided PCI
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)
Active Comparator: Angio
Procedure of stent implantation will be planned only on the basis of diagnostic coronary angiography.
Other: PCI on the basis of coronary angiography
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01205425

Locations
Poland
Institute of Cardiology
Warsaw, Poland, 04-628
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Ministerstwo Nauki i Szkolnictwa Wyższego, Warszawa, Polska
Investigators
Principal Investigator: Jerzy Pregowski, MD Institute of Cardiology, Warsaw, Poland
  More Information

Additional Information:
No publications provided

Responsible Party: Jerzy Pregowski, Institute of Cardiology, 04-628 Warsaw, Poland
ClinicalTrials.gov Identifier: NCT01205425     History of Changes
Other Study ID Numbers: N N403 295736
Study First Received: June 25, 2010
Last Updated: July 4, 2011
Health Authority: Poland: Ministry of Health

Keywords provided by Institute of Cardiology, Warsaw, Poland:
Computed coronary angiography
Stent implantation
IVUS

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

ClinicalTrials.gov processed this record on August 01, 2014